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Vol. 37, No. 24

June 13, 2011

top news Congressional cross hairs

Physician-owned device distributors scrutinized Five senior senators want the HHS Office of Inspector General to investigate the proliferation of entities that can steer surgeons to make implant choices based on personal profit. . 13

Do’s and don’t’s

FDA discusses best practices for pre-submission meetings The device center hopes upcoming guidance on pre-submission interactions will reduce inconsistencies in FDA’s handling of the informal meetings. . . . . . . . . . . . . . . . . . . . . 15

Ortho acquisition

Stryker buys Memometal for broader access to $1 billion extremities market Deal will bolster Stryker’s position in the fastest growing segment of the reconstructive orthopedic implant space. . . . . . . . . . . . . . . . . . 18

Device Industry Urges CMS To Protect Use Of Medical Innovations In ACO Program Monica Hogan m.hogan@elsevier.com

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n an attempt to prevent accountable care organizations from stifling medtech innovation, medical device groups are calling for widespread changes to a Medicare Shared Savings Program proposal unveiled earlier this spring.

CMS took comments through June 6 on its proposed ACO program, slated under health care reform to begin next January. (See “Accountable Care Orgs: CMS Proposes Plans For New Health Delivery Strategy” – “The Gray Sheet” April 4, 2011.)

ACO proponents believe that by encouraging more coordination in the care of individual patients, the voluntary program could lower health care costs by reducing duplicative tests and unnecessary hospitalizations, among other savings.

Under the CMS proposal, Medicare would share cost savings with the ACO, which would then distribute its share of savings among participating providers.

Device industry stakeholders support these general aims, but raise concerns that as written, the rulemaking does not do enough to discourage providers from withholding medically necessary products and services.

The Medical Imaging & Technology Alliance recognizes the challenges that an accountable care organization faces in trying to simultaneously achieve the three goals set forth by CMS for the ACO program – better care for individuals, better health for populations and lower growth in expenditures by eliminating waste and inefficiencies – all while not withholding needed care.

“The short, three-year timeframe for agreements under the [Medicare Shared

Device Industry Recommendations A variety of industry trade groups want specific changes to CMS’ ACO proposal. They are asking the agency to: • Develop a comprehensive, independent clinical care monitoring program • Adjust cost-saving performance benchmarks to account for new technologies and procedures • Update quality measures frequently to keep up with medical advances • Promote disease prevention by excluding costs of preventive care services from an ACO’s financial performance evaluation • Clarify the role of independent clinical laboratories in the Medicare ACO program • Adopt safeguards for the use of genetic testing and personalized medicine within ACOs • Establish a mechanism for reporting underutilization or withholding of care • Waive Medicare restrictions on certain telemedicine services in metropolitan counties • Allow telehealth services to originate from a hospice or a patient’s home

Table of Contents > page 3

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t h e n e ws t his w e e k Reimbursement • Device industry urges CMS to protect use of medical innovations in ACO program – In comments to the agency, medical device groups are calling for widespread changes to the Medicare Shared Savings Program proposal unveiled this spring. . . . . . . . . . . . . . . . . . . . Cover • Providers, device firms disagree on ACO fraud and abuse protections – When it comes to waiving fraud and abuse laws for accountable care organizations, health care providers and device companies are on distinctly opposite sides of the fence . . . . . . . . . . . . . . . . . . . . . . . . . 6 • Medical specialists seek vital role in accountable care organizations – Specialists in fields ranging from vascular surgery to orthopedics to gastroenterology are worried that their expertise may be overlooked in ACOs. . . . . . . . 8

Regulatory • FDA discusses best practices for pre-submission meetings – The device center hopes upcoming guidance on pre-submission interactions will reduce inconsistencies in the way various divisions handle these FDA-industry meetings.. . . . . . . . . . . . . . . . . . . . 15 • Shuren announces new clinical trial guidances – FDA device center director says upcoming guidance will clarify issues related to clinical trial design and approval. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14 • Regulatory news in brief – FDA has new procedures to vet information requests from reviewers. More regulatory news. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Business & Finance • AdvaMed pushes for medical innovation office in White House – The post would coordinate innovation-friendly government efforts. “Competitiveness cannot be achieved by a set of isolated policies,” the trade group argues. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

• Financings in brief – Molecular diagnostics firm Agendia seeks to raise up to $110 million in European IPO June 21. More financings. . . . . . . . . . . . . . . . . . . . .19 • News in brief – Roper snaps up Northern Digital. Merge Healthcare buys OIS. Brainlab acquires Voyant Health.

More news briefs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46

Capitol Hill • Physician-owned device distributors scrutinized – Five senior senators are urging the HHS Office of Inspector General to investigate the proliferation of entities that can steer surgeons to make implant choices based on personal profit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Mergers & Acquisitions • Stryker buys Memometal for broader access to $1 billion orthopedic extremities market – Deal will bolster Stryker’s position in the fastest growing segment of the reconstructive orthopedic implant space. . . . . . .18

People • People in brief - Stryker CEO Stephen P. MacMillan is AdvaMed chair-elect. Covidien’s Rich Meelia named chairman of Haemonetics. More people briefs. . . . . . 12

R&D • Edwards, St. Jude Medical transcatheter valve programs mark progress – FDA schedules July 20 panel review of Edwards Lifesciences’ Sapien valve. First patient is implanted with St. Jude’s investigational Portico transcatheter valve.. . . . . . . 20 • BrainScope develops device for TBI/concussion assessment – Neurology device firm BrainScope aims to begin a U.S. clinical trial within the next several months for its Ahead M-100 to aid in the detection and assessment of traumatic brain injury. . . . . . . . . 22

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t h e n e ws t his w e e k ,

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• Insituvue’s ultrasound system projects image on skin to simplify vascular access – Start-up says its investigational SFC 1000 caddy-based ultrasound system could simplify hospital practices by transitioning routine responsibility for performing vascular access procedures from a specialized team to the patient’s nurse.. . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Clinical Trials • Research in brief – Intracranial impact of AF ablation studied. No ICD survival benefit in octogenarians.

More research news . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Digital Health • Digital health in brief – Cell-Life studies HIV messaging in South Africa. ResMed releases mobile sleep assessment app. More digital health news. . . . 26

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4 | June 13, 2011

New Products • New products in brief – J&J debuts Orbit Galaxy coil system for aneurysms. Pathway Medical launches Jetstream Navitus revascularization catheter. More new products. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 • FDA’s April PMA list – Covidien/ev3’s Pipeline embolization device was one of six products to gain full PMA approval in April. FDA also signed off on 85 supplements during the month. . . . . . . . . . . . . . . . . . 30

Recalls • FDA recalls list – June 8 list includes Terumo Cardiovascular’s correction of inadequate instructions for use of the Sarns flexible weighted sucker for removing excess fluid from the surgical field, following two reported adverse events. . . . . . . . . . . . . . . . . . . . . 27

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ACO Program . . . continued from cover

Savings Program] could incentivize ACOs to implement measures that achieve immediate savings for Medicare and the ACO, but would impose costs on beneficiaries and Medicare in later years,” MITA warns in June 6 comments.

In particular, MITA worries that ACOs might restrict access to imaging services, in turn delaying patient diagnosis and treatment, “which ultimately would offset any savings achieved” during the ACO contract period.

“A short-sighted focus on immediate savings also could impede continued improvements in medical care if providers are unwilling or unable to invest in innovative technologies,” MITA adds.

MITA, AdvaMed, the Medical Device Manufacturers Association and other medtech industry stakeholders sent a number of recommendations to CMS for sweeping changes to its ACO proposed rule. (See box.)

AdvaMed wants to make sure “ACOs “don’t have the inadvertent effect of really chilling medical progress,” thus undercutting the administration’s call for federal agencies to choose the regulatory path most supportive of innovation, said David Nexon, AdvaMed senior executive vice president, in a June 8 media call.

Protect Early Adopters, Groups Advise If safeguards are not enacted, ACOs could penalize early adopters of new medical devices or procedures that may be more expensive than those used in the benchmark period, AdvaMed warns.

Under the CMS proposal, ACOs would contract with the Medicare Shared Savings Program for a three-year period.

“We all know that there are going to be important innovations coming in during that three-year period, so there has to be an accommodation within the ACOs to recognize that and to ensure that individuals are able to receive new technologies,” as well as to ensure that providers are not penalized for using them, said AdvaMed Executive Vice President Ann-Marie Lynch during the media call.

MDMA wants CMS to carve out new technologies from the expenditure calculations used to evaluate an ACO’s costsaving performance.

For example, MDMA writes, the agency could exclude the costs of any technology granted a new-technology add-on payment under the hospital inpatient prospective payment system or pass-through status under the outpatient prospective payment system from both the ACO benchmark and expenditure calculations. (See “New-Tech ‘Grace Period’ Among Industry Recommendations For ACOs” – “The Gray Sheet” Dec. 13, 2010.)

AdvaMed also is raising concerns that because Part D drug costs are not included in benchmark or spending calculations in the proposed ACO model, providers might have an artificial incentive to substitute a pain medication, for example, when a surgical procedure would be considered standard of care.

“Fundamentally, you don’t want the ACO to be substituting less expensive care for more expensive care if the more expensive care is really what the patient needs,” AdvaMed’s Nexon said.

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Clinical Laboratories Have A Stake In Changes The American Clinical Laboratory Association wants CMS to clarify the role that independent laboratories will have under a Medicare ACO program. Its concerns resemble those of physician specialty groups that worry primary care providers will take over work traditionally done by specialists. (See “Medical Specialists Seek Vital Role In Accountable Care Organizations” in this issue.)

“In a system where shared savings are awarded on the basis of comparative costs from one year to the next, the natural incentive for ACO-participating entities and professionals will be to reduce their utilization of items and services,” ACLA writes in comments to CMS. The group worries that patient access to advanced tests such as pharmacogenomic and genetic testing could be compromised unless additional safeguards are enacted.

“Many ACOs may default to using laboratories connected to hospitals that are part of the ACO for the majority of their laboratory testing,” ACLA says, but “such laboratories may not always offer these complex types of testing.”

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RCRI Reduces Risks to Clinical Data Clinical data management has traditionally focused on easing site logistic burdens. This can unintentionally introduce issues that may lead to bigger problems down the road. Overlooking data management and analysis requirements jeopardizes the ability to efficiently utilize data in analyses.

This can lead to more time and money spent on data clean-up and, in worst-case, may conclude in uninterruptable results.

RCRI has a robust team of experts with experience in clinical trial management, CRF development, database development, data analysis and medical writing. This broad based experience helps RCRI clients ensure their data are collected and analyzed in an efficient and cost-effective manner.

Led by Maria Schroeder, MPH, the RCRI Information Management team has extensive experience developing integrated data collection, storage, and analysis solutions for simple and complex medical device clinical trials.

Please contact Maria Schroeder, MPH at 952-224-2255 or mschroeder@rcri-inc.com about your data needs.

June 13, 2011 | 5

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Providers, Device Firms Disagree On ACO Fraud And Abuse Protections David Filmore d.filmore@elsevier.com

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hen it comes to waiving fraud and abuse laws for accountable care organizations, health care providers and device companies are on distinctly opposite sides of the fence.

On the one hand, powerful provider groups say it is already a stretch to expect hospitals and doctors to lay out the substantial resources needed to form these new coordinated health care networks, and take on all of the additional requirements for transparency, quality reporting and business practice restrictions that come with them.

The least the government can do, they argue, is to give providers broad latitude to implement ACOs without constant worry of legal action.

The least the government can do, powerful provider groups suggest, is to give hospitals and doctors broad latitude to implement ACOs without constant worry of legal action. ”There is no justification for applying the traditional fraud and abuse laws to ACOs or other types of clinically integrated organizations that engage in the same type of accountable, coordinated care activities,” writes Rick Pollack, executive VP of the American Hospital Association, in recent comments.

But that thinking makes device manufacturers nervous.

Companies see ripe opportunities in proposed ACO regulations for inappropriate financial arrangements between hospitals and clinicians to standardize selection of lower-cost devices, restrict certain treatments or take other actions to lower costs that impact use of new technology.

For industry, it is a continuation of the hospital-physician gainsharing debate that escalated in 2005, but this time on a larger scale. (See “Medicare Gainsharing Demos Still Have A Pulse, CMS Release Confirms” – “The Gray Sheet” Aug. 24, 2009.)

Many of the waivers that are envisioned leave the door wide open to product standardization arrangements, says Thomas Novelli, VP of government relations for the Medical Device Manufacturers Association, in written comments. ”MDMA believes that standardization cannot be achieved without limiting access to innovative items, supplies and devices,” he writes.

Self-Referral, Kickbacks, And Gainsharing CMS issued a proposed rule in March to govern the practices of accountable care organizations that will be set up based 6 | June 13, 2011

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on a provision in the health care reform law enacted last year. To form an ACO, hospitals, doctors and other providers in the same region will join together to coordinate care activities with the goal of reducing costs while maintaining care quality. (See “Accountable Care Orgs: CMS Proposes Plan For New Health Delivery Strategy” – “The Gray Sheet” April 4, 2011.)

Under the new program, intended to be up and running

by January, CMS will share a portion of the savings generated by ACOs with the ACO (and, in some cases, will financially penalize ACOs for going above certain cost benchmarks).

The formation of ACOs and the distribution of “shared savings” among collaborators in an ACO will necessarily trigger new types of financial relationships in health care – relationships that might not technically fall within legal lines under at least three statutes currently on the books: the physician self-referral law, the antikickback statute, and a section of the civil monetary penalty law that restricts “gainsharing” payments from hospitals to physicians to limit services.

Although a range of exceptions and safe harbors to these laws have already been established, such allowances may not cover ACOs, a fact that Congress recognized in the health reform law by specifically providing more leeway for the Health and Human Services Department to waive the laws for the new organizations when necessary.

For industry, it is a continuation of the hospital-physician gainsharing debate that escalated in 2005, but this time on a larger scale.

As a result, CMS and the HHS Office of Inspector General issued a notice in conjunction with the March ACO proposed rule to map out potential waiver policies. Providers and device firms make their divergent views on the topic clear in recent comments responding to the waiver notice.

CMS and OIG say they plan to issue waivers to ACOs under each of the three statutes, with the most emphasis on protecting the practice of distributing shared savings.

The self-referral law restricts referrals by a physician when the clinician has a financial stake in the services being performed more or less often. Due to the likely need for referrals between participants of the ACO to accomplish coordinated, cost-saving practices, transfers of shared savings from one party to another could raise a problematic financial tie.

Thus, HHS says it will waive self-referral restrictions for shared savings distribution between ACO parties and from an ACO to outside parties “for activities necessary for and directly related to” ACO participation.

Waivers would be granted to the kickback and gainsharing statutes for shared savings distributions as well.

Further, HHS proposes to waive the requirements of those © 2011 F-D-C Reports, Inc., an Elsevier company. All rights reserved.

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two laws to protect certain other financial relationships, beyond shared savings distributions. Specifically, there would be allowances for arrangements forged between ACO participants if the agreements are necessary for the operation of the ACO, but only if the agreements fit within previously established exceptions to the physician self-referral law.

Beyond that, the agencies ask for input on what other waivers might be necessary. ”We recognize that the proposed waivers ... do not cover all of the possible financial arrangements involved with setting up and operating an ACO,” CMS and OIG wrote in the proposed notice.

Providers: To Function, ACOs Need Broad Waivers Hospital and doctor groups couldn’t agree more. And they argue that unless the agencies explicitly waive fraud and abuse laws for a much broader set of activities, it could stall the ACO program before it even begins. ”No consideration is made for the significant upfront financial investment that will be required,” American College of Cardiology President David Holmes writes in comments to the agencies. “Nor does the proposed rule consider the potential for novel financial arrangements that might be created to deal with the complexities that arise from increased clinical integration across multiple organizations.”

The American Hospital Association agrees. ”The linchpin of an ACO’s success will be the ability of its participants to work together and provide seamlessly integrated care,” notes AHA’s Pollack. “The participants will have to start their collaboration long before the ACO begins operations and to do that they will need waiver protection that spans the spectrum of activities from the planning stages through the completion of the three-year agreement. ”The waivers discussed in this notice, however, do not begin to address those needs.”

In particular, the problem highlighted by these and other groups is the fact that financial arrangements other than shared savings distributions, while potentially waived from an-

tikickback and gainsharing enforcement, will need to comply with current exceptions to the self-referral law.

This would severely restrict the ability, for instance, of larger hospitals or physicians to invest or donate needed resources to smaller ACO participants to set up systems and processes required to properly coordinate care, they say. ”ACOs are premised on collaboration and integration, innovation, and contributions from all participants – often in-kind – towards success of the overall operation,” Pollack writes. “The Stark [self-referral] law is premised on keeping providers at arm’s length, suspicion of remuneration, rigorous and detailed formularies, and strict liability.”

AHA proposes a much less restrictive “ACO Waiver” program, which would cover just about all ACO activities, from formation through the end of participation in the Medicare ACO program.

Waivers should also allow for a broad range of incentive payments, in addition to shared savings, made by hospitals to physicians or other providers – whether the recipients are direct participants in the ACO or not – to support the overall cost and quality goals of the ACO, provider groups argue. ”More immediate and tangible incentives will be required,” beyond the shared savings distributions, to trigger practice changes among care givers, argues Blair Childs, senior VP of public affairs for the hospital group purchasing organization Premier. ”Otherwise, there is a real danger that the success of the ACO experiment will be clouded by the ‘line of sight’ problem – an inability of physicians to perceive that their individual efforts can really affect the achievement by the entire ACO of shared savings,” Childs writes in Premier’s comments to CMS and OIG.

Device Firms Fear Perverse Incentives This type of talk catches the notice of device executives, who worry about the move of treatment decision-making authority out of the hands of physicians and into the hands of centralized hospitals or ACOs.

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In particular, waiving requirements of the antikickback statute and the gainsharing civil monetary penalty provision “would likely give rise to greater product standardization in the hospital setting and could potentially limit patient access to innovative medical technologies,” writes Thomas Novelli, VP of government relations for the Medical Device Manufacturers Association, to CMS and OIG. MDMA expresses serious reservations about any additional waivers, and in particular calls on the agencies not to create any new physician self-referral exceptions until completion of a Medicare demonstration program (enacted by the 2005 Deficit Reduction Act) that is testing hospital-physician gainsharing on a much more limited, six-hospital basis. That program is actually one of two Medicare gainsharing demonstration projects underway. (See “Gainsharing Snapshot: New Jersey Hospital Exec Discusses Demo Project” – “The Gray Sheet” Sept. 7, 2009.)

In addition, OIG has granted individual waivers to more than a dozen gainsharing programs that include product standardization and other cost-saving measures tied to tight quality monitoring.

But AdvaMed argues that CMS should be able to grant waivers to protect distribution of shared savings without allowing incentives for product standardization and other gainsharing arrangements. And CMS should be explicit about making that distinction in its final rule, the device trade group states in its comments on the waiver issues.

The “critical element” on this matter, writes AdvaMed’s Ann-Marie Lynch, is that the providers participating in the ACO shared savings program will be “paid standard Medicare fee-for-service rates.”

Hospitals, for instance, will receive the same inpatient DRG payment for a procedure whether a less or more expensive device option is employed, and could gain savings if the less expensive option is chosen. But Medicare does not save any money based on that choice, explains Lynch, the trade association’s executive VP of payment and health care delivery policy.

ACOs should therefore not be granted waivers for such practices, she argues for AdvaMed. ”An ACO’s planned and actual distribution of savings should be scrutinized to ensure that savings paid to practitioners do not reflect participation in savings initiatives that financially benefit providers, but not the Medicare program,” she writes.

Generally, AdvaMed, unlike provider groups, supports a very strict interpretation of the CMS and OIG proposal to limit waivers to payments that are “necessary for and directly related to” ACO operations.

The group says it wants to prevent protections for some practices that it describes as “legally problematic,” such as hospitals subsidizing physician office leases or staff expenses or entering into profit-sharing agreements with physicians in exchange for use of lower cost devices.

AdvaMed also highlights the practice of hospitals using products purchased from distributors owned by physicians practicing at the facility “without regard to quality or individual patients needed.” (See in this issue, “Senators Seek Scrutiny Of Physician-Owned Device Distributors.”) ”Expanding the waiver authority would open the door to protecting activity that presents a significant risk of patient abuse,” Lynch argues.

Medical Specialists Seek Vital Role In Accountable Care Organizations

Groups Warn Of Potential Barriers To Care

Monica Hogan m.hogan@elsevier.com

S

pecialists in fields ranging from vascular surgery to orthopedics to gastroenterology are worried that their expertise may too often be overlooked in accountable care organizations formed under a new Medicare Shared Savings Program.

Several specialty societies are warning CMS that medically necessary services could be withheld due to the central role the agency gives to primary care physicians in running accountable care organizations in the proposed ACO rule issued in March.

(See “Accountable Care Orgs: CMS Proposes Plan For New Health Delivery Strategy” – “The Gray Sheet” April 4, 2011.)

In comments due June 6 responding to the proposal, societies ask CMS to clarify the role specialists will play as part of an ACO and to ensure that they have a greater voice in constructing ACO practice guidelines.

The groups also request safeguards that would assure appropriate patient referrals to specialists as well as ACO quality measures that apply to individual medical specialties, such as neurology, endocrinology and gastroenterology.

8 | June 13, 2011

ACOs as envisioned by CMS are integrated networks of hospitals, physicians and other providers formed to coordinate care in a manner that cuts costs but maintains quality. Under the proposed rule an ACO would receive a portion of the savings to Medicare generated by the group’s efforts.

Some specialty groups, while supporting the overall goals of the program, suggest that they are troubled by CMS’ emphasis on primary care physicians playing such a strong role in the formation and governance of ACOs. Proponents of this ACO oversight model believe that primary care physicians are in the best position to curb overutilization of diagnostic tests and unnecessary procedures. But specialists worry that the policy proposal may be weighted too heavily against them.

“Most experts agree that the fee-for-service [payment] model can create inappropriate incentives for providing unnecessary care, driving up costs and reducing quality,” the American Society for Radiation Oncology writes in comments. “On the other end of the spectrum, an ACO can also create inappropriate incentives to stint on care. A balance must be struck between these two models.”

The American Gastroenterological Association notes

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a concern that “CMS’ ACO model inadvertently creates a gatekeeper model that will only create care disruption for patients and erect barriers to care.” It adds that certain patients with complex chronic conditions may even want to designate a specialist as their primary care provider within an ACO.

Some specialist groups suggest that medically necessary services could be withheld because of the central role given to primary care physicians in CMS’ proposed ACO rule.

“Allowance of primary care alone tacitly assumes that unnecessary services or inappropriate care only happens at the specialty level,” says the North American Spine Society.

The Society for Vascular Surgery recommends that CMS require ACOs participating in the Medicare Shared Savings Program to ensure appropriate access to specialists “in accordance with professional society clinical practice guidelines.”

Financial incentives for ACOs to reduce costs could lead primary care physicians to limit their referrals for medically necessary tests and specialist care, SVS warns. It asks CMS to monitor the health status of beneficiaries in ACOs against comparable populations of Medicare beneficiaries outside ACOs. Specialty groups are also concerned that primary care physicians participating in ACOs will attempt to take on the role of specialty physicians in making diagnoses that could be better left to specialists.

For example, neurologists would be in a better position to follow evidence-based medicine to diagnose multiple sclerosis or to treat patients hospitalized for ischemic stroke, the American College of Neurology says.

In joint comments, The American College of Gastroenterology and the American Society for Gastrointestinal Endoscopy worry that in an effort to cut costs, primary care physicians may steer patients away from colonoscopy and perform fecal occult blood tests to screen for colon cancer instead.

Additional Quality Measures Proposed Specialty medical societies are asking CMS to consider requiring quality measures around disease-specific conditions and specialty services, including: • Stroke rehabilitation • Radiation therapy in post-operative breast cancer • Vascular surgery in the frail elderly • Cardiovascular outpatient registry use • Timing of repeat colonoscopies in patients with a history of polyps

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“We want to make sure that patients also have full access to colonoscopy, which allows for the detection and removal of polyps, thus allowing for the prevention of colorectal cancer,” the groups write.

Inclusion Within Governance Boards Specialists further want CMS to clarify their role within ACO governing bodies charged with creating care guidelines for ACO members.

According to the American Association of Orthopaedic Surgeons, “specialist physicians can and should play a vital role” in drafting guidelines such as appropriate use criteria for referral to specialists, as well as advanced diagnostic imaging and other pre-referral testing; appropriate indications for therapeutic procedures; and clinically relevant performance measures related to specialty care.

Other specialty societies also argue for inclusion.

Without strong participation from specialists, “an ACO governing body may decide to disallow endocrinologists to perform certain procedures and remove some of the important tools used by an endocrinologist that enable them to provide the high quality of care for which they underwent years of specialized training,” writes the American Association of Clinical Endocrinologists.

The group wants to protect an endocrinologist’s ability to perform in-office evaluations of thyroid disorder patients using ultrasound guided fine needle aspirations, as well as DXA bone density scans for the early diagnosis of osteoporosis.

The American Association of Clinical Endocrinologists also urges CMS to allow groups of specialists to form ACOs targeting high-risk, high-cost subpopulations of a specific disease or condition, such as diabetes.

Goals Align With Some Device Priorities Device companies expressed similar apprehensions that the ACO regulations could restrict access to specialists, who are often the clinicians who perform device-dependent procedures.

CMS should create guidelines to make sure primary care physicians actively refer patients to specialists when appropriate, MDMA says.

In comments to CMS, AdvaMed argues that incentives to reduce costs can lead providers to attempt to achieve savings by withholding referrals to specialists or high-cost tests and interventions, “even when this is the most appropriate treatment for the individual patient.”

The trade association wants CMS to require ACO providers to create strong informed consent practices that highlight a patient’s right to seek care from specialty providers that are not participants in an ACO. June 13, 2011 | 9

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The Medical Device Manufacturers Association says that CMS must go beyond requiring ACOs to maintain beneficiary freedom of choice in seeking outside specialists, but create guidelines to make sure primary care physicians actively refer patients to specialists when appropriate.

“We are concerned that ACOs might try to control costs by delaying referrals to specialists,” MDMA says. “Such delays could be extremely harmful to the beneficiaries’ health, but the costs of postponing diagnoses and treatments might not be captured during the three-year [ACO] agreement period.”

The Medical Imaging & Technology Alliance, meanwhile, suggests that CMS should require ACOs to consider relevant clinical guidelines developed by specialty societies including the American College of Radiology and the American College of Cardiology as they develop internal guidelines for patient care.

Role Of Quality Measures Industry also calls for additional quality measures specific to specialty care.

“AdvaMed strongly recommends that CMS include rigorous outcome measures specifically ensuring that specialty care is not in any way inappropriately limited or denied,” the group comments.

AdvaMed Pushes For Medical Innovation Office In White House Jessica Bylander j.bylander@elsevier.com

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evice industry trade group AdvaMed is urging the Obama administration to create an office of medical innovation policy within the White House.

The post is needed to coordinate and advocate for innovation-friendly government efforts, the group says.

The president should also require that all new regulations include a statement about their “innovation impact,” as means of forcing agencies to consider how their actions impact device and drug makers, AdvaMed says.

The trade group announced several policy proposals June 6 aimed at improving the competitiveness of the U.S. medical device industry.

A White House medical innovation office would “serve as our advocate across the government” – AdvaMed’s Steve Ubl AdvaMed is calling for a government-wide strategy to boost American competitiveness and innovation in the life sciences industries to include FDA regulatory reforms, Medicare coding and payment reforms, and updated trade and tax policies that are more favorable to U.S. industry.

10 | June 13, 2011

The 65 quality measures that CMS has proposed for its ACO program “are useful but insufficient to assure quality care,” AdvaMed says. It notes that the agency’s proposed rulemaking does not include measures for a number of serious illnesses prevalent within the Medicare population, including cervical, ovarian, pancreatic and lung cancer; Alzheimer’s disease; glaucoma; osteoarthritis and gout.

The fact that the 65 quality measures do not go far enough in measuring an ACO’s quality of care is “not so much a commentary on CMS as it is on the current state of the art in quality measures,” David Nexon, senior executive vice president for AdvaMed, acknowledged during a June 8 media call.

Several specialty societies are also requesting additional quality measures to address performance in the areas of focus of their members. (See box.)

But other provider groups are asking CMS to cut back on the number of required quality measures that ACOs need to report – or at least to phase them in slowly over time to reduce administrative burdens.

But AdvaMed’s Nexon does not think it would be a good idea to step back from quality measures. “One of the main goals of this program is not to just cut cost, but also to improve quality,” he stressed.

Coordinated Innovation Strategy But first and foremost, innovation efforts need a home in the White House, AdvaMed argues. ”Competitiveness cannot be achieved by a set of isolated policies,” the association wrote in materials released June 6.

“It requires a coordinated, government-wide strategy involving all the agencies that affect industry.”

A White House office of medical innovation policy would provide a focal point for voicing concerns about the impact

AdvaMed’s Competitiveness Agenda The agenda includes six main pillars.

1. Life science innovation must become a government priority, such as with the creation of a White House medical innovation policy office.

2. The FDA review process must be reformed.

3. New payment policies, such as accountable care organizations, must support medical innovation.

4. Trade policies, such as free trade agreements, must support export growth and level the playing field for U.S. manufacturing.

5. Tax policies that level the playing field between U.S. and foreign governments, such as comparable R&D tax credits, must be implemented.

6. American R&D infrastructure must be improved, such as with increased funding for Small Business Innovation Research grants.

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that agency decisions and policies will have on competitiveness and innovation, and “serve as our advocate across the government,” AdvaMed President and CEO Steve Ubl said on a June 6 conference call.

President Obama issued an executive order earlier this year requiring federal agencies to write regulations that protect public health and safety while also “promoting economic growth, innovation and competitiveness.” (See “Device Innovation: Report Paints Dire Picture; Prez, FDA Take ‘Positive’ Steps” – “The Gray Sheet” Jan. 24, 2011.)

But AdvaMed urges the administration to go a step further and require that all new regulations include an innovation impact statement. ”The goal would be to assure that every agency takes into account the effect of its actions on medical innovation and related domestic employment, and economic growth,” the group’s competitiveness agenda states.

For instance, AdvaMed says, CMS’ recently published proposed rule on accountable care organizations does not discuss what impact the measure would have on innovation.

The association has previously pitched to the President’s Council of Advisors on Science and Technology the ideas of a White House-based innovation office and a mandatory innovation-impact statement. (See “Gephardt-Led Group Steps Up Medical Innovation Lobbying Effort” – “The Gray Sheet” June 14, 2010.) But the group suggested it was renewing efforts to engage White House officials on the proposals. ”I think there’s going to be interest in all aspects of the agenda,” David Nexon, AdvaMed senior executive VP, said on the call.

“We’re hopeful that they’ll be willing to move forward on it.”

Recommended FDA Reforms AdvaMed’s additional policy recommendations reflect many long-standing advocacy goals of the device industry.

The group calls on FDA to reduce the total time it takes to review new medical devices, and improve its investigational device exemption process to make it easier to begin clinical trials in the U.S. ”Delays in IDE approval … are a major drag on U.S. competitiveness and one of the most important factors leading manufacturers to move clinical trials and first product introductions abroad,” AdvaMed stated.

FDA must also do a better job of considering the “least burdensome” means of establishing device safety and effectiveness, and eliminate requirements that are not necessary to protect public health, AdvaMed argues. ”When FDA insists companies submit greater data than is needed to meet the statutory requirements of a reasonable assurance of safety and effectiveness, the cost and time necessary to develop new treatments and diagnostics soars,” AdvaMed wrote.

FDA: Already Addressing These Issues FDA says it is already addressing most of AdvaMed’s proposals for the agency through its planned 510(k) and PMA program reforms. ”We are already taking actions that will help improve the competitiveness of the American medical device inUnauthorized photocopying is prohibited by law.

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Losing The Lead?

While the U.S. currently dominates the roughly $350 billion global device market, that leadership is threatened, AdvaMed says, noting that: • 87.5% of companies in one AdvaMed survey foresee higher employment growth outside the U.S. in the future.

• The trade balance for the med-tech industry, while still positive, has been cut by two-thirds over the last 10 years.

• The value of the U.S. R&D tax credit ranks 24th out of 38 Organization of Economic Cooperation and Development countries.

Source: AdvaMed and U.S. government data

dustry,” an agency spokeswoman said, adding that FDA’s mandate requires it to look out for patients, as well as industry interest.

FDA acknowledges that it has not always applied the least burdensome principle consistently, and is making internal changes to address this, including the formation of a CDRH Center Science Council that will monitor and ensure the consistency of the center’s scientific decision making.

In other specific proposals, AdvaMed says the federal research and development tax credit should be raised to 20% and offered to small start-ups that have not yet made a profit, perhaps as a refundable credit.

Meanwhile, the group argues that the 2.3% excise tax on medical device sales, passed as part of health reform, should be repealed.

AdvaMed announced the competitiveness agenda at an event at a Stryker manufacturing facility in Kalamazoo, Mich.

House Energy and Commerce Committee Chairman Fred Upton, R-Mich., and Sen. Debbie Stabenow, D-Mich., also attended the June 6 event. ”Streamlining … unnecessary and duplicative regulations will keep U.S. companies competitive on the global market,” Upton said.

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Peo p le I n B rief Stryker CEO MacMillan is AdvaMed chair-elect

Stryker president and CEO Stephen P. MacMillan is on deck to be the next chairman of the board of AdvaMed, starting in March 2012, according to the trade group.

MacMillan was named chairman-elect in March. He will serve a two-year term, succeeding current chairman James V. Mazzo, president of Abbott Medical Optics.

MacMillan is an active lobbying force for Stryker and for device issues in general, and maintains frequent contact with House Energy and Commerce Committee Chairman Fred Upton, R-Mich. Stryker’s headquarters in Kalamazoo is in the committee chairman’s home district.

(See “Device Industry Friend to Head Energy And Commerce Panel” – “The Gray Sheet” Dec. 13, 2010.) MacMillan joined Stryker in 2003 as president and chief operating officer, and became CEO in January 2005.

Systagenix CEO

British wound management company names Ernest Waaser CEO, effective June 6. Waaser most recently was president of Teleflex Medical, and prior to that served as president and CEO of Hill-Rom. (See “Teleflex Takes Aim At Critical Care Market With Arrow Acquisition” – “The Gray Sheet” July 30, 2007.) He replaces Steve Atkinson, who will continue to work with One Equity Partners as a consultant and advisor on device investments. Waaser is expected to help Systagenix enter the field of wound diagnostics with its Woundchek diagnostics franchise.

Hansen Medical CFO

Maker of robotics for 3D catheter control taps Peter J. Mariani to

12 | June 13, 2011

serve as chief financial officer, effective June 20. Mariani replaces Peter Osborne, who has been interim CFO since February 2010.

Mariani’s background includes 12 years in senior financial positions at Guidant Corp. He will report directly to President and CEO Bruce Barclay, who said Mariani’s experience “will be very useful as we prepare for an expected launch of our vascular robotic system later this year.” (See “Robotics: Corindus, Hansen Pursue Vascular Cath Lab Indications” – “The Gray Sheet” March 14, 2011.)

Minntech CEO injured in plane crash

Roy K. Malkin, president and CEO of Minntech Corp., a subsidiary of the infection prevention and control product maker Cantel Medical Corp., suffered serious injuries after his private single-engine plane crashed at Crystal Airport near Minneapolis on June 4. Malkin’s condition was listed as serious but stable as of June 10. During his recovery, division heads at Minntech will report to Cantel president and CEO Andrew Krakauer, while Minntech Executive VP Paul Helms will serve as site leader, assisting with oversight of the firm’s day-to-day operations. Cantel acquired Minntech, a dialysis products and renal dialyzer reprocessing company, in May 2001.

Meelia elected Haemonetics chairman

Blood management solutions firm has elected Rich Meelia chairman of the board, effective June 6. Meelia will retire as Covidien’s president and CEO July 1, remaining as non-executive chairman of that firm. He replaces former Haemonetics chairman Brad Nutter, who served at Haemonetics

as CEO until November 2010 and is now retiring as chairman. Meelia, a former Tyco executive with close to 40 years of health care industry experience, will be succeeded at Covidien by Joe Almeida. (See “People In Brief” – “The Gray Sheet” March 21, 2011.)

NovoStent chair

The privately held start-up focusing on stents to treat peripheral artery disease has appointed Rick Randall chairman of the board, effective April 2011. Randall is currently chairman and CEO of Avantis Medical Systems and chairman of TransS1, developer of treatments for degenerative spine conditions. (See “People In Brief” – “The Gray Sheet” Jan. 10, 2011.)

Randall replaces Timothy Mills, who will remain a board member.

NovoStent President and CEO G. Ray Martin said Randall’s experience with development-stage companies will be an asset for the firm, whose SAMBA stent and delivery system received a CE mark in Europe in March 2010.

Cayenne Medical’s new medical director

Sports medicine device firm specializing in soft tissue reconstruction appoints Dev K. Mishra medical director, firm says June 1. Mishra will provide counsel in the areas of medical education and clinical research activities. He is board certified in orthopedic surgery and orthopedic sports medicine, and currently advises several venture capital firms, including SV LifeSciences, Onset Ventures and the Innovation Factory. Cayenne Medical CEO David Springer said Mishra’s experience in sports medicine will be invaluable for the firm’s development of new products.

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Senators Seek Scrutiny Of Physician-Owned Device Distributors David Filmore d.filmore@elsevier.com

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ive senior senators are urging the Health and Human Services Office of Inspector General to investigate the proliferation of entities that can steer surgeons to make implant choices based on personal profit.

The bipartisan group of lawmakers is also calling on CMS to make sure it protects against inappropriate conflicts of interest that may arise from these physician-owned distributors, or PODs, as part of two major regulations the agency plans to release this year.

In letters to CMS and the HHS OIG dated June 9, the lawmakers say PODs, which typically buy orthopedic implants from manufacturers and resell them to the hospitals where the physician investors practice, clearly raise significant potential for conflicts of interest. Namely: surgeons can profit by choosing to implant devices sold by the distributor in which they have an ownership investment.

While orthopedic implants are the largest focus of PODs, the model is quickly branching out into other markets, including cardiac implants, the Hatch report notes.

But, the senators note, the physician-owned entities exist in a legal gray zone. ”There are a variety of models which are utilized, some of which may indeed be appropriate, but the potential for conflicts of interest in this physician ownership model, the safety concerns for patients, and the potential impact on costs to the health care system raise a number of troubling issues about PODs and other similar arrangements which we believe merit further inquiry,” the lawmakers state in both letters.

The senators, led by Orrin Hatch, R-Utah, ask HHS Inspector General Daniel Levinson to take a more detailed look into PODs than OIG has in the past, and to report back findings, including recommendations for enforcement actions and legislation.

The request follows a recent inquiry initiated into the physician-owed device distributors by Hatch, who is ranking member of the Senate Finance Committee. Chuck Grassley, R-Iowa; Finance Committee Chairman Max Baucus, D-Mont.; and Special Committee on Aging leaders Herb Kohl, D-Wis., and Bob Corker, R-Tenn., also signed the letters.

PODs Are Proliferating According to a June 9 report issued by Hatch’s staff, PODs started to crop up in California in 2003, and have rapidly proUnauthorized photocopying is prohibited by law.

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liferated in that state and others during the past 18-24 months.

The POD model is being used “very aggressively” in rural areas, the report notes. And while orthopedic implants are by far the largest focus of PODs, the model is “quickly branching out” into other markets including cardiac implants, according to the report. The assessment was based on interviews with 50 people, including physicians, hospital employees and device industry representatives.

Business models adopted by PODs include those that mirror a traditional distributor model, arrangements where the original device manufacturer is treated as a contract manufacturer, or structures where PODs act as physician group purchasing organizations, the report explains.

Some physician-owned groups have apparently instituted protections to prevent direct conflicts, such as not tying physician compensation in any way to implant volumes, but there are other set-ups in which compensation appears to directly depend on implant volumes, the report notes.

Regardless, the lawmakers tell OIG that questions have been raised in interviews conducted for the report “about whether PODs serve any legitimate value.”

AdvaMed Has Encouraged POD Scrutiny The scrutiny from lawmakers aligns with priorities of device trade group AdvaMed, which has complained about the business practices of PODs for years.

AdvaMed said that it “welcomes” the inquiry. ”We have long expressed concerns that physician owned distributorships raise ethical and legal concerns, specifically issues relating to the anti-kickback statute,” said Chris White, AdvaMed’s general counsel, in a prepared statement. “No patient should ever be concerned that financial incentives are distorting their care in the selection of one medical technology over another.”

AdvaMed is urging the Medicare agency to include public disclosure requirements for physician investment in PODs in upcoming draft regulations for the physician payment sunshine law that was enacted as part of health care reform. (See “Device, Hospital Groups Want All-Encompassing Physician Sunshine Rule” – “The Gray Sheet” April 18, 2011.)

The senators make the same request in their separate letter addressed to CMS Administrator Donald Berwick. ”The POD model at its basic level is exactly the type ... envisioned by the Sunshine Act, which would require disclosure of the financial interests of their physician investors,” the letter states.

The lawmakers’ comments to Berwick also mirror AdvaMed concerns on the potential for new fraud and abuse waivers that are being entertained for new accountable care organizations to protect inappropriate activities by PODs. (See in this issue, “Providers, Device Firms Disagree On ACO Fraud And Abuse Protections.”)

CMS is aiming to finalize regulations by year end for a shared savings program to encourage development of ACOs. “The final rule should prohibit ACOs from purchasing products and services from entities that are owned by physicians participating in the ACO,” the senators write.

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Large Ortho Firms Stand To Gain From Scrutiny Financial analysts who follow the implantable device market see the congressional scrutiny as an opportunity for the bigger players in the orthopedic space, particularly the spine market, where PODs have delivered some market share to smaller players and driven down prices.

According to Larry Biegelsen, an analyst with Wells Fargo, the focus will likely “lead to PODs either being eliminated or severely restricted, but this may take a year or so to play out,” he noted in a June 9 research note. “Such an outcome would be beneficial to the larger spine players.”

AdvaMed brought the PODs issue to the attention of OIG back in 2006 with an inquiry into the office’s opinion on the legality of the entities.

OIG responded that the entities should be “closely scrutinized under the fraud and abuse laws.”

Shuren: New Clinical Trial Guidelines In The Works Jessica Bylander j.bylander@elsevier.com

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DA device center director Jeffrey Shuren says new guidance documents coming down the pike will clarify issues related to clinical trial design and approval.

Shuren announced the upcoming guidances at a June 9 session of the Medical Device Manufacturers Association annual meeting in Washington, D.C. FDA is developing guidelines on first-in-human studies to address very early investigations of a new device, prior even to feasibility studies, with an eye to facilitating this type of research domestically. Industry and clinical researchers have recently lamented the dearth of earlystage studies in the U.S. (See “U.S. Could Speed Device Innovation Through Clinical Research Reforms” – “The Gray Sheet” March 7, 2011.) ”How can we move that along the device development pathway so we can start those studies even earlier in the U.S., and allow for you to do those iterative changes without coming back through a mound of process and bureaucracy,” Shuren said.

That guidance is expected out by the end of October.

FDA is also developing guidance on its criteria for approving the start of a clinical trial, including clarifications on “conditional approval” of a trial. FDA often grants conditional approval of investigational device exemption studies, allowing the trial to begin, but noting lingering questions or concerns that must be addressed. About 5% of IDEs receive full approval without conditions, the agency says.

14 | June 13, 2011

But the senators stressed that more specific guidelines and enforcement policies are sorely needed. ”There is as much confusion in [OIG’s] stance on PODs as there is confusion in the health care community about how to arrange these in a legal manner,” they write. “Until there is clarity, inappropriate versions of these entities could continue to proliferate, potentially driving up medical device costs to the Medicare and Medicaid programs and putting patient safety at risk.” ”You can expect OIG will look into it,” said Julie Taitsman, chief medical officer of the HHS OIG, during a June 10 session of the Medical Device Manufacturers Association annual meeting in Washington, D.C. “But we would look at it just using the same principles that we apply to all business arrangements,” she said, noting that OIG has no “special rules” for PODs. The lawmakers want to hear back from CMS by July 15. Meanwhile, they expect an initial report from OIG by Aug. 12.

”There are times where we will say, as a condition of approval, here are the things we expect,” Shuren said. “Well, in some cases, the things we expect really don’t matter that much. If they don’t matter that much, then they shouldn’t be a true condition of approval.”

Some firms say the use of “conditional” can be confusing for institutional review boards or payers, who assume there are still major outstanding issues with the device. ”The terminology conditional approval, for some IRBs, is almost like a death sentence,” Shuren acknowledged. “We’re looking to also clarify that for IRBs.” That guidance also should be out by the end of October, he said.

Another guidance, due out in July, will focus on the quality and conduct of clinical trials, with recommendations on how to design a study “so that it appropriately minimizes bias while applying the ‘least burdensome’ principle,” Shuren said.

Risk-Benefit Guidance Separately, FDA is crafting guidance on the appropriate factors to use to make benefit-risk determinations. Industry has called for changes to how FDA weighs benefits and risks. (See “Innovation Efforts Offer A Way To Change FDA’s Views On Risk, Industry Says” – “The Gray Sheet” March 21, 2011.) ”We make those decisions all the time in the center, but nowhere is it written down, ‘Here are the things you take into consideration,’” said Shuren, who is taking the lead on that guidance working group.

The guidance will detail the risk and benefit factors FDA considers, as well as what the agency takes into consideration when weighing the two, such as disease severity and the patient’s tolerance of risk.

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Making The Most Of PreSubmission Meetings: FDA Discusses Best Practices Jessica Bylander j.bylander@elsevier.com

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DA’s device center hopes upcoming guidance on presubmission interactions will cut down on inconsistencies in how various divisions handle these FDA-industry meetings. ”Different divisions have different approaches for how they deal with meeting scheduling, and how they approach that,” Angela Krueger, a regulatory advisor in the Office of Device Evaluation, explained during a June 7 Regulatory Affairs Professional Society device submissions workshop.

Some ODE divisions have checklists or guidelines for what should be included in a pre-submission meeting request package, but others do not. ”Some of them do have that process a little more formalized,” Krueger said.

Upcoming guidance aims to make pre-submission meeting policies more consistent from division to division.

And some divisions informally limit the number of presubmission meetings that firms can request, she said. Further, pre-submission meeting procedures may differ between the device evaluation office and the diagnostics office. ”Right now there are a lot of problems with [the program],” CDRH Director Jeffrey Shuren acknowledged at the Medical Device Manufacturers Association annual meeting last week in Washington, D.C. ”In revamping the guidance, pre-submission policies should be more consistent from division to division,” Krueger told “The Gray Sheet.”

FDA’s draft guidance on pre-submission interactions is expected out in November. (See “Industry Experts Debate Impact Of FDA’s Upcoming Pre-IDE Guidance” – “The Gray Sheet” May 16, 2011.)

Agency and industry representatives offered tips on how to make the most of pre-submission meetings with FDA at the RAPS workshop in Rockville, Md.

Pre-IDEs Steadily Increasing Pre-submission meetings, in particular, have become popular in recent years.

FDA says the number of applications for pre-submission feedback has nearly doubled over the last five years, up to 650 applications in 2009, the most recent year for which data is available.

The “pre-IDE” program was created in 1995 to encourUnauthorized photocopying is prohibited by law.

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age early interaction between FDA and sponsors prior to submission of an investigational device exemption application. But firms now use the program to obtain feedback on 510(k)s, PMAs and humanitarian device exemption filings as well, FDA says.

FDA has been encouraging companies to hold pre-PMA meetings, Krueger said. ”The goal of these meetings is essentially to discuss your PMA strategy,” she said. “Discuss what the format of that application will be, reflect on any key preclinical and clinical finding, and really call out the anomalies or the things that you think are going to be issues.”

The upcoming draft guidance will address the various types of applications, Krueger said.

Binding Meetings A Bust?

A primary criticism of the pre-IDE program is that both sponsors and FDA are technically free to ignore the advice from these informal meetings.

But while firms can pursue binding pacts with FDA through either determination or agreement meetings, they rarely do.

These formal pre-submission meetings were authorized in the 1997 FDA Modernization Act. Sponsors of PMA products can request determination meetings where FDA defines what constitutes the valid scientific evidence needed to demonstrate effectiveness of the device.

Agreement meetings, where FDA and industry agree on a binding investigational plan and study protocol, are available for PMA and 510(k) products that are class III devices or implants.

The statute allows FDA to deviate from the binding agreement in limited instances. Mela Sciences last month charged that FDA reneged on its binding protocol agreement without due cause. (See “Citizen Petition: FDA Reneged On Binding Agreement For Melanoma Device” – “The Gray Sheet” May 16, 2011.)

Overall, however, binding agreements have not proven particularly useful, Krueger acknowledged. ”These aren’t used all that much,” she said. “Folks have found that utilizing the more informal pre-IDE process as opposed to these formal meetings is a more efficient approach for them.”

Krueger added that FDA generally doesn’t backtrack on recommendations from informal pre-IDE meetings unless the meeting was held years before an application was submitted or FDA learns of problems with that particular device class or study design. ”We should be standing behind that advice,” device center director Shuren commented at the MDMA meeting. “That requires a bit of a culture change because we have some people who do it in the center and some people who don’t.”

According to Heather Rosecrans, former head of FDA’s 510(k) staff, binding recommendations seem good on paper, in terms of reducing uncertainty in pre-market reviews, but “it’s very difficult to make that process work.” ”They’re just not perfect because science isn’t perfect,” June 13, 2011 | 15

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said Rosecrans, now a consultant with Greenleaf Health. “Science is just not black and white.”

The former FDAer agreed that the informal pre-submission program is often inconsistently applied. ”When it works, it’s great, but the process is not really uniform,” she said.

To be most helpful to industry, the new guidance should explain what to include in a pre-IDE request and what firms can expect from the agency in terms of timelines and feedback, Rosecrans said.

The guidance should also explain what the program can be used for, and what it can’t. For instance, pre-submission interactions should not involve a review of the sponsor’s data, she cautioned. ”I don’t believe the pre-IDE process was set up for review of data,” she said.

Codifying the pre-IDE program in a regulation would provide greater predictability, Rosecrans said, but adequate guidance may suffice.

Pre-Submission How-To Sharon Timberlake, director of regulatory affairs at Palomar Medical Technologies, detailed what firms should include in the meeting request packet they send to FDA.

Too often, firms come to the meetings with more questions than answers, FDA says.

A cover letter should give sponsor information, explain why the meeting is being requested, the device name and proposed intended use, a draft agenda for the meeting and specific questions the firm would like to address during the meeting.

Sponsors should also explain who will attend and name three to four potential meeting dates and times, Timberlake suggested.

The packet should also include a device description, a summary of any previous testing and a description of the planned pilot or pivotal study.

Start-u -Up

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ierBI.com Intelligenc e | www.Elsev Elsevier Business

JANUARY 2011 | Vol. 16 No. 1 |

1 VALUATION WATCH

The A-List:

’s Trend-Shaping 10 2010 gs Series A Financin

Investors Will Rise Of Corporate Returns?

Lead To Return Of Device

AND TOM LASH, MARK RATNER

SALEMI

ALEX infusion of venture seeking their first e Investments for start-ups firms seek later-stag be scarce as venture of capital continue to their own chances liquidity to improve opportunities and raising new funds.

BY PAUL BONANOS,

: Masterminds Of Ardian

view With InventorsLevin 24 AnMarkInterGelfa nd And Howard

of Ardian, the object s the inventors behind acked medical device Start-Up interview riced venture capital-b five other medical one of the highest-p the two of them, acquisitions, and between device companies.

BY MARY STUART

PROFILES

Emerging Medical Ventures

Wave Of Benlysta May Lead Lupus Drugs New Approvals For

approval for an easier pathway to of Benlysta may create ty for other 34 The looming approval while leaving a potentially broad opportuni s, other lupus candidate its label. protein. drugs to fill gaps in

2 VENTURE ’ROUND

y Ltd. Cancer Research Technolog To CancerBiopharma’s Gateway Focused Academic Research Where Private Medtech In 2010 Investment Dollars Went VCs, Genocea Chooses Corporate Sale?

Perhaps Presaging A

51 SCIENCE MATTERS

Finds Antigen-Free Screening For Antibody Biomarkers Alzheimer’s Diagnosis

52 ON THE MOVE

In Who’s Going Where Biopharma And Medtech Start-Ups

Elsevier Business Intelligenc

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e | www.ElsevierBI.com

| Vol. 15 No. 7 | JUly/AUGU ST 2010

all pro File S iSS ue

Alzheimer’s start -Ups face A Discovery And Clinic al Crossroads With big Phase III failures heating debate about must

the amyloid hypothesis convince investors that , small biotechs early research is pointed ones must design clinical in the right direction, trials with care. and larger 10 AlzProtect’s drugs boost neuroprotective factors to prevent Alzheimer’s 12 Axerion Therapeut . ics targets prions to halt Alzheimer’s progressio n.

14 Cognition Therapeut ics takes on toxic proteins that lead to Alzheimer’s 15 Galantos’ galantamin . e prodrug modulates nicotinic receptors to treat Alzheimer’s.

The future Of Lapa rosco 18 singl e incision, nOTEs py: And

robots

The skill sets of laparoscop all converging to create y, endoscopy, robotics and even interventio the the new surgical instrument least invasive surgeries. Start-ups are nal cardiology are innovating to supply s.

22 EndoControl gives endoscopic surgeons

a robotic helping hand. over-the-scope wound closure for flexible endoscopy . fundamental problems of access with new ports of entry.

26 Virtual Incision’s in vivo mini robots work where surgeons can’t.

23 Ovesco Endoscopy offers

24 SurgiQuest solves the

start-Ups 28 Acros s Health Care

Emerging Medical Ventures

1 Valuat ion Watch

As Some VCs Run On Empty, Others Are Topping Off The Tank

2 Ventur e ’round Calithera Biosciences Takes $40 Million First Round

TCT Medical Offers A New Model For Device Distribution In China Cadence, VCs Relieve J&J’s Pain, Map Out A Clever Exit In The Process

46 on the moVe Who’s Going Where In Biopharma And Medtech Start-Ups

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59 EXECUTIVE SUMMARIES

eradicate type 2 diabetes

16 | June 13, 2011

Of Recent Financings Private Companies And Tech Transfers Between Academia And Industry

Audax Medical, Fluence

Therapeutics, Implandata

Ophthalmic Products,

Metagenomix

recent financings Of Private Companies And Tech Transfers Between Academia And Industry

Firms should be careful not to overload the packet, Timberlake said. “You really want to focus on the device itself, indications, and why you’re having this meeting.”

If the company plans to discuss a pilot or pivotal study, it should describe the patient population to be studied, inclusion and exclusion criteria, the treatment and follow-up schedule, sample size justifications, statistical analysis methods and the number of planned investigation sites, she said. ”The primary endpoints and the assessment tools for safety and effectiveness: those you really want to nail down,” Timberlake emphasized. “That’s really what’s probably going to get you clearance of your product.”

Too often, FDA’s Krueger said, firms come to the meetings with more questions than answers. ”We’re not going to be able to provide consulting advice,” she said. ”They don’t write your protocols, they don’t write your endpoints, but if you put something together and you’re able to defend it, they’ll … critique it and give you some valuable input,” Timberlake added.

Meeting Tip: No Surprises Timberlake and Krueger also cautioned firms not to introduce new material at the pre-submission meeting that was not included in the request packet. ”FDA is not prepared,” Timberlake said. “They’ve only seen what you provided them. You can try to go back and add information before your meeting, but keep in mind that may delay [it.]”

If a company is contemplating a significant change, such as redesigning a protocol, it makes sense to delay the meeting, she noted. ”If you’re going to submit extensive new information, you should plan to postpone or cancel a meeting you already have scheduled,” Krueger added.

Usually pre-submission meetings last an hour. Sponsors should build in time to set up their presentation, and should leave as much as half an hour for questions after the presentation.

If for some reason a key FDA expert cannot attend at the last minute, “definitely continue on with the meeting,” Timberlake said. Send meeting minutes to the expert later for his or her input, she said.

Within 6-8 weeks of receiving a request, FDA generally sets a date for the meeting, Timberlake noted.

In addition to pre-submissions meetings, firms may also request meetings with FDA during a PMA or 510(k) review, such as to discuss a deficiency letter or labeling disagreement, Krueger said.

For instance, FDA encourages all PMA sponsors to request a so-called 100-day meeting when they submit their application. These meetings allow FDA and sponsors to address deficiencies that may have been identified, and to “facilitate the end game,” Krueger said.

Firms can always cancel the 100-day meeting later if they don’t need it, she said. © 2011 F-D-C Reports, Inc., an Elsevier company. All rights reserved.

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R egulator y N ews I n B rief FDA will vet information requests to sponsors

FDA says it is implementing new procedures this month to make sure that it is appropriately vetting device reviewers’ requests for additional information on pre-market submissions. Device makers have raised concerns that FDA review times are delayed by unnecessary demands for new information and data. In its own analysis, FDA found that longer review times may be attributed to unnecessary information requests from FDA in less than 10% of 510(k)s.

But, “That should never happen,” CDRH Director Jeff Shuren acknowledged at the Medical Device Manufacturers Association annual meeting June 9. “If you’re going to ask for something different than you asked for before, you have to lay out [the reasons] why,” Shuren told reporters at the meeting.

Nanotech guidance

FDA does not establish a regulatory definition for nanotechnology in draft guidance issued June 9, but the agency describes its current thinking on when regulated products contain nanomaterials or involve the application of nanotechnology. “It is critical for FDA to understand how changes in physical, chemical or biological properties seen in nanomaterials affect the safety, effectiveness, performance or quality of a product that contains such materials,” the agency said on release of the draft.

FDA says it will develop additional guidance on specific products or product categories as needed.

Also on June 9, the White House

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Office of Science and Technology Policy, Office of Management and Budget, and Office of the United States Trade Representative issued policy principles on nanotech regulation. Nanotechnology involves manipulating or engineering materials on the molecular scale.

Colorant guidance in the works

FDA is developing guidance on the use of colorants in medical devices, an agency device staffer said last week. Device makers say they have been receiving increasing inquires from CDRH about use of colorants in PMA and 510(k) devices. “We’re seeing many more questions on biocompatibility, especially around colorants,” Candice Burns, a regulatory affairs manager at Boston Scientific, said at a June 7 Regulatory Affairs Professional Society meeting in Rockville, Md. Colorant requirements are part of the statute, Angela Krueger, a regulatory advisor with CDRH, emphasized during the meeting. “We do plan on putting guidance out on what we’re looking for for colorants later this year, so hopefully that will help,” she said.

X-ray equipment assemblers: updated guidance

FDA released updated guidance for assemblers of diagnostic X-ray equipment June 3, replacing a guide that dates back to 1980. The guidance distinguishes between the reporting, labeling, installation and other responsibilities of diagnostic X-ray equipment assemblers and those of manufacturers, based on various performance standards.

Assemblers, who install or replace components of an X-ray system,

are not subject to most of the same reporting and record-keeping requirements as full-fledged manufacturers, the guidance says.

Philips/Oridion recall Philips Healthcare and Oridion Medical recalled lots of infant and neonatal-sized FilterLine H Set and VitaLine H Set Microstream carbon monoxide sampling lines due to findings that plastic strands on the inner surface of an airway adapter could dislodge and be inhaled by the patient. The firms initiated the recall in April and FDA deemed it a high-risk Class I action on June 6. Inhalation of the plastic strands may cause respiratory problems, which could result in serious illness or death. To date, neither company has received reports of injury related to this issue.

Datascope balloon pump recall FDA classified Datascope Corp/ Maquet’s voluntary worldwide field correction of certain intra-aortic balloon pumps as a Class I recall, the firm said June 6. Datascope initiated the field correction of its 98/98XT, CS100/CS100i, and CS300 IABP models in March. To date, 840 U.S. customer pumps and 453 international pumps have been affected. The fan assembly to the power supply in the defective units could potentially contain a misshapen retaining ring, which could disengage within the fan, causing the fan blade assembly to stop rotating. As a result, the power supply would detect an overheating event and shut down.

The firm provided an upgraded power supply to customers with affected balloon pumps.

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Stryker Buys Memometal For Broader Access To $1 Bil. Extremities Market Zach Miners z.miners@elsevier.com

“When you look at the extremities market, we’re really focused on the growth that has occurred for the surgical podiatrist” – Stryker VP Curt Hartman Memometal sells elbow, wrist, hand, ankle and foot implants made from nitinol, a nickel-titanium alloy that allows the implant to be modified after it is anchored to bone.

Specific offerings include Anchorage foot and ankle joint plating systems, Smart Toe implants for hammertoe arthrodesis, MemoStep heat-activated fixation devices and Easy Clip stapling products. Memometal notes that a majority of its devices available in Europe under CE mark approval also have received FDA market go-ahead.

In extremities, Stryker already markets the Dynamic Joint Distractor II (elbow), Hoffman II Compact External Fixation System (wrist) and VariAx plating system (hand), among other offerings. The firm reported sales of $222.6 million in its trauma and extremities segment for the most recent quarter, up 2%.

The Memometal deal will help Stryker build up its foot and ankle offerings in particular, noted Curt Hartman, Stryker VP and chief financial officer.

“When you look at the extremities market, we’re really focused on the growth that has occurred for the surgical podiatrist,” Hartman said at the June 7 Jefferies 2011 Glob18 | June 13, 2011

Photo: Memometal

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tryker will expand its presence in the orthopedic extremities market through its purchase of privately held French firm Memometal Technologies for $150 million up front, plus up to $12 million in milestone payments. The definitive agreement was announced June 6.

The roughly $1 billion worldwide orthopedic extremities market is currently the fastest-growing segment of the reconstructive orthopedic implant space, expanding at a roughly mid-teens percentage rate, analysts say.

Stryker is paying a premium for that growth, with the purchase price coming in at a relatively hefty 5.4 times Memometal’s 2010 sales of $30 million. However, Memometal notes that it expects to generate 2011 sales of $45 million – up 50% over the prior year.

The deal will bolster Stryker’s current status as the second-largest player in orthopedic extremities, behind firstplace player Johnson & Johnson/DePuy, analysts note. Other large competitors in the sector include Zimmer, Wright Medical and Biomet.

Memometal’s Smart Toe implant for arthrodesis provides enhanced fixation due to its super-elastic properties, the company claims. al Healthcare Conference in New York.

“We have internally developed some products that have allowed us to participate in that segment, but certainly not to the scale and magnitude that the market growth is demanding. So we’re very excited about the acquisition,” Hartman said.

Beyond feet and ankles, Stryker is not downplaying the importance of the hand and wrist sub-sector. “It would be a reasonable assumption that we will focus on the broad extremities segment over time and build out our presence” through internal development or acquisitions, or both, the exec suggested.

Other Stryker offerings include a broad range of artificial hip and knee reconstructive implants, as well as medical/surgical equipment, neurotechnology and spine devices. Stryker’s total reconstructive ortho implant sales were roughly flat in the first quarter at $911.1 million.

Nitinol Technology A Key Asset The super-elasticity and “shape memory” properties of the nitinol technology behind many of Memometal’s implants is a key asset of the deal.

The technology allows the implants to return to their original shape after deformation, upon reaching a certain temperature, the company explains.

According to Hartman, Stryker is interested in leveraging the technology and applying it to “not only extremities, but perhaps other platforms within the company.”

While Stryker “is paying a premium for Memometal, we think it is justified by Memometal’s nitinol capabilities and the extremities market’s mid-teens growth rate,” said device analyst Michael Matson of Mizuho Securities in a June 6 report.

The market growth “is primarily being driven by product innovation, which allows favorable mix shifts and better pricing” than other segments of the ortho space, Matson said.

The growth potential could make more acquisitions likely in the extremities space. However, “as larger firms increasingly focus on the extremities market, we think competition is likely to increase for smaller extremities players” like Integra © 2011 F-D-C Reports, Inc., an Elsevier company. All rights reserved.

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LifeSciences, Tornier and Wright Medical, Matson noted.

The broader orthopedic space is currently particularly ripe for consolidation, analysts say.

The Memometal purchase comes less than a month after Stryker’s purchase of Orthovita. Stryker announced a definitive agreement to buy the ortho firm and its line of synthetic orthobiologics for $316 million on May 16. (See “Stryker Bets $316 Million It Can Invigorate Orthovita’s Biologics Biz” – “The Gray Sheet” May 23, 2011.)

The latter deal came on the heels of competitor J&J’s massive $21.3 billion purchase of orthopedic implant maker Synthes in April. (See “J&J Doubles Down On Orthopedics With Synthes Deal, Takes Lead In Trauma” – “The Gray Sheet” May 2, 2011.)

Other Stryker acquisitions over the past year include support surface and pressure ulcer management company Gaymar Industries, biomaterial and surgical implant maker Porex Surgical, and the neurovascular business of Boston Scientific.

F inancings I n B rief Agendia plans IPO

Maker of the MammaPrint in vitro diagnostic multivariate index assay for predicting breast cancer recurrence seeks to raise up to $110 million through an initial public offering on the NYSE Euronext stock exchange in Amsterdam, the firm announced June 6. The Dutch molecular diagnostics firm plans to offer up to 4.59 million shares at $24.01 to $28.12 per share, based on current exchange rates. The proceeds are tabbed mainly to expand U.S. sales and marketing capabilities.

Agendia’s flagship MammaPrint is part of the firm’s Symphony suite of four currently available breast cancer tests, which also includes TargetPrint, BluePrint and TheraPrint. The complementary tests provide “a comprehensive support system for oncologists to determine whether a breast cancer patient is likely to benefit from hormonal therapy, chemotherapy and targeted therapies,” Agendia explains. The company, which reported 2010 sales of $6.9 million, gained an initial FDA market go-ahead for MammaPrint in 2007. (See “FDA Clears First-Of-AKind Breast Cancer Recurrence Test” – “The Gray Sheet” Feb. 12, 2007.)

Agendia products in the pipeline include the firm’s ColoPrint gene expression profiling test for colon cancer recurrence. A portion of the IPO proceeds is earmarked “to complete technical and clinical validation and initial commercialization of ColoPrint,” the company says. Agendia plans

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to seek FDA market clearance for ColoPrint within the next two years.

R&D projects also include expanded breast cancer offerings and a test for lung cancer. Agendia expects trading of its IPO shares to begin on June 21 under the stock symbol “AGDX.” Underwriters for the offering include ABN AMRO, ING, KBC Securities and Kempen & Co.

Mauna Kea Technologies eyes IPO

Maker of the 510(k)-cleared Cellvizio probe-based confocal laser endomicroscopy system for in vivo cellular imaging plans an initial public offering later this year on the NYSE Euronext Paris stock exchange, according to the company.

The Paris-based firm notes that Cellvizio is cleared by FDA for use in the gastrointestinal and pulmonary tracts and also has received a CE mark in Europe. The device can be used for cellular-level imaging of tissue in the body to improve the diagnosis of cancer and other diseases, according to the company.

Mauna Kea Technologies announced its preliminary IPO filing June 6. “The potential IPO is planned for 2011, depending on market conditions and [Autorite des Marches Financiers, or French market authority] approval of the company’s prospectus,” the company says.

Arstasis raises $25.5 million

Arterial access device maker raises $25.5 million in a “Series E” private placement with a combination of 12 institutional and individual investors, the firm announced May

25. Headquartered in Redwood City, Calif., Arstasis announced earlier in May the U.S. launch of its Axera nextgeneration system for femoral artery access. Use of the device allows minimal manual compression to be used for secure closure of the vessel following a femoral procedure, the company explains. The device makes Arstasis’ first-generation Arstasis One Access device obsolete, as it “streamlines procedural steps to make the overall procedure easier,” the company explains. The latter device debuted in January. Arstasis has raised $67 million in capital to date. (See “Arstasis Angioplasty Device Launch” – “The Gray Sheet” Jan. 17, 2011.)

Sapiens gets $19 million Sapiens Steering Brain Stimulation raises $19 million in a “Series A” private placement co-led by Wellington Partners and Edmond de Rothschild Investment Partners, announced June 1. The funds will be used for further development of Sapiens’ deep brain stimulation (DBS) system, as well as software, first-in-man validation and regulatory approval in Europe, according to the company. The Dutch firm is initially developing its MRI-compatible DBS implant for patients with Parkinson’s disease.

The SBS steering brain stimulation system comprises both implants and navigation and steering software to facilitate accurate placement of electrodes in the target area of the brain, the company explains.

June 13, 2011 | 19

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Edwards, St. Jude Transcatheter Valve Programs Mark Progress David Filmore d.filmore@elsevier.com

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dwards Lifesciences and St. Jude Medical each marked notable milestones in the closely watched transcatheter aortic valve space last week.

Of most near-term significance to the U.S. market, Edwards on June 7 announced that FDA has officially scheduled, for July 20, an advisory panel meeting to address the company’s Sapien transcatheter valve. The firm also received some positive incremental reimbursement news.

And much further back in the development cycle, St. Jude announced the first-ever human implant of its Portico transcatheter valve.

Neither of the disclosures comes as a big surprise to market observers.

Panel Date In Line With 2011 Sapien Launch Plan

Photo: St. Jude Medical

The July 20 FDA panel meeting will specifically address Edwards’ PMA application for delivery of the Sapien valve via the transfemoral artery to treat inoperable severe aortic stenosis patients.

Edwards is working toward a late-2011 U.S. launch of Sapien for this indication. Market analysts believe that goal will likely be met based on the strength of the mortality advantage Sapien showed compared to medical management in pivotal trial data reported last year. (See “ Getting Set For Sapien: With Data In, Discussion Moves To Adoption Dynamics” – “The Gray Sheet” April 11, 2011.)

St. Jude says its investigational Portico transcatheter aortic heart valve can be repositioned following initial placement during a procedure.

20 | June 13, 2011

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Edwards is also prepping a separate FDA submission (which could require a second panel meeting) for tranfemoral or transapical delivery of Sapien in high-risk, but operable patients.

Coincidentally, also last week CMS quietly finalized its ICD9-CM procedure codes, including distinct new codes for femoral and apical delivery of a transcatheter aortic valve (and a code for transcatheter pulmonary valves, as well).

CMS has finalized new ICD-9 codes for transcatheter valve procedures.

The codes are in the same category as the established reimbursement identifier for open-heart aortic valve replacement. This may support Edwards’ short-term reimbursement goal for the Sapien procedure to be paid under the same inpatient diagnosis-related group as open surgery.

It also supports the longer-term goal of Edwards and other transcatheter-valve-focused firms for an eventual separate payment category for the nascent procedures.

St. Jude: CE Mark Trial To Begin By Year End St. Jude, already a notable player in the surgical heart valve space, first disclosed its transcatheter valve development plans in 2009. At that time, the firm stoked expectations of initiating clinical trials by the end of 2010 at the earliest. (See “St. Jude Unveils Plan To Launch Transcatheter Aortic Valve By 2012” – “The Gray Sheet” Feb. 16, 2009.)

The first implant of the Portico system took place last week at St. Paul’s Hospital, Vancouver, British Columbia. The procedure kicks off a small feasibility trial that St. Jude hopes to follow up on with a larger study by the end of the year to support a European CE mark.

The firm has previously suggested it could gain a CE mark sometime in 2012. It also expects to submit an investigational device exemption application to FDA for the device in the first half of next year.

In Europe, Portico would come up against two already well-established players in the field – Sapien and Medtronic’s CoreValve.

St. Jude says Portico will compete with significant technical advantages. In particular, the firm highlights that the valve can be re-sheathed, repositioned or retrieved during a procedure, following its initial placement.

But St. Jude is not the only firm to make the claim of improved positioning for a second-generation transcatheter valve.

Boston Scientific, with its recently acquired Sadra Medical Lotus valve, as well as Direct Flow Medical, JenaValve and Symetis (Acurate TA), have all reported first-in-man studies for valves that the firms say can be repositioned or retrieved, or include other technology enhancements, to aid precise positioning.

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N ew Products I n B rief J&J/Codman’s Orbit Galaxy

Johnson & Johnson subsidiary Codman & Shurtleff debuts Orbit Galaxy detachable coil system for endovascular treatment of cerebral aneurysms June 8. The 510(k)cleared system is comprised of a family of coils, Codman says, for physicians to treat the majority of cerebral aneurysms from start to finish. Also, the system’s complex, random loop design results in significantly higher packing than helical coils and complex coils with pre-determined shapes, the release states. The first device in the Orbit Galaxy line, the Xtrasoft Orbit Galaxy endovascular finishing coil, launched last summer as part of a phased rollout of the product family, the company explains.

Animas/Dexcom’s Animas Vibe

Johnson & Johnson/Animas gains European CE mark for its Animas Vibe, an integrated, continuous glucose monitoring-enabled insulin pump system developed in collaboration with CGM device maker Dexcom. The first integrated product from Animas and Dexcom, the device incorporates the latter firm’s G4 CGM technology – the only sensor approved for up to seven days of wear, according to the company. (See “Dexcom Deals Integrate Glucose Monitor With Insulin Pumps” – “The Gray Sheet” Jan. 14, 2008.)

The pump functions as a receiver for the glucose sensor, and the system “delivers real-time glucose information, alerts for high and low readings, and glucose trend information,” J&J/Animas explains in a June 2 release.

Pathway’s Jetstream Navitus

Pathway Medical Technologies launches its Jetstream Navitus revascularization catheter for treatment of peripheral vascular

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disease following receipt of 510(k) clearance, announced June 6.

Building on the capabilities of the firm’s Jetstream G3 peripheral atherectomy catheter, which debuted in 2010, Navitus’enhanced features enable improved performance in tortuous anatomy as well as active aspiration, which allows the user to continually remove excised tissue and thrombus while operating the device, Pathway says. This “both reduces procedure time and minimizes the risk of distal embolization,” the company explains in a June 6 release.

The catheter also features, for the first time, “an expandable blade that makes it possible for physicians to use a single device to treat blockages in arteries of varying sizes, from the superficial femoral artery to below the knee,” a spokesperson told “The Gray Sheet.”

Its cutting tip safely debulks and preemptively removes both hard and soft plaque as well as calcium, thrombus and fibrotic lesions, the device maker says.

Gore hybrid vascular graft

W.L. Gore & Associates commences U.S. launch of its Gore hybrid vascular graft, indicated for use “as a vascular prosthesis for dialysis access or bypass for other peripheral vascular diseases,” the firm announces June 1. Originally 510(k)-cleared in March 2010, the device was further evaluated in a 130-patient clinical evaluation prior to the official launch, the company explains. Three-month follow-up data on 76 of the study patients “demonstrates a trend toward a reduction in revision procedures, thrombosis events and seroma, as compared to historical graft data,” the device maker explains.

Gore says the device’s over-thewire deployment simplifies vessel access through a smaller than usual

incision in the skin that reduces vessel injury and dissection. “The [graft] has been used to create new access sites in anatomical locations that would have been abandoned otherwise,” the Flagstaff, Ariz.-based firm claims.

Mazor Robotics’ Renaissance Firm’s Renaissance next-generation robotic surgical guidance system debuts June 6. The device, which was 510(k)-cleared in April and also has a CE mark, builds on the capabilities of the Israeli firm’s SpineAssist predecessor system, incorporating new interface, hardware and software technologies that extend the range of clinical applications, enabling osteotomies, transfacet and translaminar-facet implant placements, in addition to spinal fusions and scoliosis corrections, the company claims.

The technology is intended to offer enhanced performance in spinal surgery, compared to freehand surgeries, by increasing placement accuracy and reducing neurologic risks, Mazor says.

ThermoGenesis’ Res-Q 60 Firm plans a commercial launch by year-end for its Res-Q 60 system for preparing autologous platelet rich plasma from a small sample of blood at the patient’s point of care. ThermoGenesis announced 510(k) clearance for the application June 2. The platelet rich plasma is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics, the company explains. Platelet rich plasma also has been shown to enhance healing, according to ThermoGenesis. The company’s first product, Res-Q 60 BMC, is used to concentrate stem cells from bone marrow aspirate.

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BrainScope Develops Device For TBI/Concussion Assessment Rebecca Kern rebecca.kern@elsevier.com

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Photo: BrainScope

eurology firm BrainScope aims to begin a clinical trial in U.S. emergency departments within the next several months for its Ahead M-100 to aid in the detection and assessment of traumatic brain injury.

BrainScope CEO Michael Singer says miniaturization, simplicity and usability are the most important features of the novel device.

“Our philosophy is that if a device is very usable, it will be used. So that’s why we spent so much time on the simplification, usability and the hand-held size,” Singer said in an interview.

The company’s initial market focus is the U.S. military, where traumatic brain injury has been “a major problem,” Singer said. Eventually, he sees use of the device in U.S. civilian settings, as well.

The firm also expects to begin a clinical validation study this summer on its Ahead EU-100 for urgent care use in the U.K. On the larger European front, BrainScope aims to obtain a CE mark by the end of the year.

According to Singer, U.S. emergency rooms report approximately 1.4 million visits a year for head injuries; in the U.K., the figure is about 1 million.

“Being able to identify and classify TBI early on is a dramatic benefit to all constituencies in the health care system – patients,

first and foremost, and certainly providers and payers,” he said.

Ahead M-100 consists of a portable, hand-held electroencephalography (EEG) device, which is connected by a cable to a disposable headset containing eight electrodes. Placement of the headset on the patient can be done and EEG read-outs obtained in about five minutes, Singer said.

“This device is a way for there to be triage that will also save all of us unnecessary costs and unnecessary radiation exposure” – BrainScope CEO Michael Singer That contrasts with traditional EEG machines, which are bulky, require expert data interpretation, may involve 19-64 electrodes, and can take 20-40 minutes for placement and output, Singer said.

A medical professional should be able to use the Ahead M-100 after just one day of training, he added.

Structural And Functional Brain Assessment The hope is that the device will help clinicians initially determine whether a patient has sustained structural injury. In addition, the company wants the device to help identify various levels of functional brain injury.

“The read-outs are meant to be straightforward and actionable for triage,” Singer said. ”We focus a lot on being able to disaggregate a person who has normal brain function and a person who has signs of abnormal brain function,” he explained.

Going even further, the company is attempting to have the device disaggregate gradations of more or less abnormal brain function. “That’s a very important element for clinicians: not only to understand if the patient is normal or not, but if the patient is functionally abnormal, just how bad might it be.”

BrainScope’s technology relies on a unique algorithm to interpret and classify the electrical brain activity picked up by the headset electrodes.

“We are attempting to make sense out of the digital wave form and to try to create these unique algorithms for appropriate classification,” Singer said.

“This device is a way for there to be triage that will also save all of us unnecessary costs and unnecessary radiation exposure, which can lead to long-term consequences.”

But in the end, Singer says, the final neurological assessment is up to the physician. “This is all still based on physician decision. We are one of many tools that physicians can use to help determine the level of injury that a person has sustained when they hit their head.”

U.S. Clinical Trial The Ahead M-100 hand-held device provides an assessment and categorization of structural and functional brain injury.

22 | June 13, 2011

In May, BrainScope and FDA reached concurrence on key design elements for the firm’s U.S. pivotal clinical trial.

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Challenges In Developing Devices For TBI/Concussion Diagnosis Experts discussed the challenges around developing technology to aid in the diagnosis of traumatic brain injury and concussion at a June 2-3 FDA workshop in Silver Spring, Md. Potential approaches to helping identify TBI range from electroencephalography technology, neuro-cognitive tools and reaction time tools to blood biomarkers, serum studies and genetic studies.

“One very common theme from this workshop that had very wide consensus was that, in general, none of these devices can be used for diagnosis of concussion, but rather to document brain dysfunction so that the clinician can make an accurate diagnosis,” said Jeffrey Kutcher, assistant professor of neurology at the University of Michigan and director of the school’s Michigan NeuroSport concussion pro-

gram, who participated in the workshop and spoke later with “The Gray Sheet.”

There are many challenges in identifying a concussion with a device, Kutcher said, the first being the technical challenge of developing a system that can be used reliably in acute settings. A larger hurdle is conducting the background research “so that we know what the output means,” he said. Brain wave activity, he explained, “can be affected by so many other things.”

Current devices that incorporate electro-physiology, including EEG, “are fraught with the same problem, which is what are they measuring and what does it mean clinically?” he said.

“I think moving forward, there is a need for devices that do all kinds of things, including blood markers that can pick up injury, including EEG, including neuro-cognitive devices.”

While BrainScope says the product is a non-significant risk device that does not require a formal investigational device exemption from FDA, it remains unclear what type of premarket regulatory application the firm will need to submit.

“It’s novel, but it’s non-significant risk; it’s a major health problem; the military needs it badly. You add all of these variables together and it’s going to be an FDA call as to how it’s classified,” Singer said.

The prospective trial will take place in 10 emergency departments across the U.S., with the possible addition of more sites that have expressed interest.

The trial will enroll hundreds of patients who have sustained head injuries and seek to identify whether or not they have brain injuries. In particular, it will examine “that discrimination between visible structural brain injury and functional impairment,” according to Singer.

Also confounding TBI diagnosis are co-morbid conditions, such as ADHD, or physiological states, like sleep deprivation, which can affect the test output.

“There are just so many things that can affect overall brain frequency that we have to make sure that these devices are stable, with those things being considered,” explained Kutcher.

Companies hoping to obtain FDA clearance or approval for TBI/concussion diagnostic devices should provide a clear definition of concussion, the intended device user and their level of expertise, and the intended environmental setting of use, workshop participants advised. Developers should also clearly define what the device output means and how to interpret it, they said.

“We are very focused on making sure this is a product that is heavily used, and the only way any product is heavily used is for it to have substantial clinical efficacy and for it have price value,” he said. “One of our major levels of focus is to ensure that pricing is compelling for those to use it.”

Following regulatory clearance, the firm plans to pursue reimbursement discussions in the U.S. “There are very substantial reasons why insurance companies can and should look at these problems; there’s so much under-diagnosis,” he said.

The firm also plans to begin a clinical trial at three sites in the U.K. this summer. The trial will have the same protocol as the U.S. clinical trial.

Britain’s National Health Service “likes clinical proof,” observed Singer, “so we’ve taken a very unique step as a small company in stepping into that system and doing the hard work of clinical proof locally there.”

BrainScope recently formed a subsidiary in the U.K. to help commercialize the product throughout Europe. It was aided

by Think London, London’s official foreign direct investment agency, and U.S. Trade & Investment, the British government’s international development agency.

Although he declined to discuss pricing specifics, Singer said the firm intends to make the system affordable.

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Photo: BrainScope

Wooing Britain’s National Health Service

The disposable headset contains eight electrodes.

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R esearch I n B rief AF ablation: intracranial impact?

Medtronic/Ablation Frontiers’ PVAC multielectrode radiofrequency ablation catheter was associated with a significantly higher incidence of asymptomatic embolic lesions following an atrial fibrillation pulmonary vein isolation procedure compared to ablation with a conventional irrigated RF catheter or a cryoablation catheter in an observational study posted online June 8 in the Journal of the American College of Cardiology.

Researchers from Germany and France performed ablations on 74 patients with AF using one of the three types of catheter systems.

They took magnetic resonance imaging scans before and after the procedures. A single new embolic lesion was spotted on the MRI post-procedure in two of 27 patients treated with a standard RF catheter (Biosense Webster’s ThermoCool or St. Jude Medical’s Cool Path Duo) and in one of 23 treated with Medtronic’s Arctic Front cryoablation catheter. But nine of 24 patients treated with PVAC showed on average 2.7 new lesions following the procedure.

More study on the PVAC procedure is needed to understand the origins of the lesions, which did not cause symptoms but could be a risk factor for neuropsychological deficits, the researchers note. PVAC is available in Europe, but not yet in the U.S. The catheter employs 10 electrodes to ablate more tissue at once to speed what are often laborious pulmonary vein isolation procedures. (See “Medtronic Makes Another Big Play In A-Fib, Purchases Ablation Frontiers” – “The Gray Sheet” Jan. 19, 2009.)

No ICD survival benefit in octogenarians

Patients aged 80 and older with left ventricular dysfunction

24 | June 13, 2011

gain no survival benefit from use implantable cardioverter defibrillators, researchers concluded in study results posted June 2 in The American Journal of Cardiology.

A team from the University of Pittsburgh Medical Center retrospectively analyzed outcomes from 99 patients who received an ICD at their institution from January 2000 through December 2008 and another 53 patients at the center with similar clinical characteristics who did not get an ICD. In both groups, patients were at least 80 years old, had a left-ventricular ejection fraction of 35% or less and were followed for an average of 2.3 years.

On a direct comparison, patients with the implant experienced better one-year survival rates. But after adjusting for age, ejection fraction and various comorbidities, there was no survival advantage in the device group, the researchers concluded.

RF-aided vertebral augmentation

A vertebral augmentation procedure employing radio-frequency-treated bone cement shows promise for improving pain in patients with vertebral compression fractures due to multiple myeloma, according to a study reported last week at the American Society of Neuroradiology annual meeting in Seattle. DFINE, which markets the StabiliT RFtargeted vertebral augmentation device, announced the results June 8.

The system employs RF energy to transform polymethylmethacrylate into an ultra-high-viscosity state that the company says allows for more controlled and precise delivery of the substance into a cavity-creation device inserted into a fracture. Researchers from the University of Arkansas treated 66 patients for upper thoracic malignant vertebral compression fractures with the system. After six months of follow-up, there were statistically significant improvements

in pain, activity and narcotics use; no pulmonary or neurological complications; and one instance of asymptomatic cement leakage, the team said. Vertebroplasty and balloon kyphoplasty are not commonly performed in the upper thoracic spine, which is a riskier part of the anatomy than the lower thoracic or lumbar spine regions, the researchers pointed out.

DFINE launched the StabiliT system based on a 510(k) clearance in 2008.

Lymph node irradiation

Regional lymph node irradiation improves disease-free survival and lessens the chance of cancer recurrence in women with earlystage breast cancer who have had a breast lumpectomy, according to a study presented June 6 at the American Society of Clinical Oncology annual meeting in Chicago.

Researchers from the NCIC Clinical Trials Group followed for five years 1,800 women who had undergone surgery and drug therapy combined with either whole-breast radiation or whole-breast radiation plus regional lymph node irradiation.

They observed a more than 30% improvement in disease-free survival for woman receiving regional lymph node irradiation, associated with a 41% lower rate of recurrences in the breast and lymph nodes, and a 36% recurrence rate reduction in other regions. Prior to treatment, most of the women had three positive lymph nodes, while 10% had high-risk, node-negative breast cancer.

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Don’t Look Away: Insituvue’s Ultrasound Device Projects Image On Skin To Simplify Vascular Access Mark Hollmer m.hollmer@elsevier.com

Insituvue Quick Facts • Lead product: SFC 1000 • Venture funding: Conducting a “Series A” round to raise $2.5 million • Number of employees: 3 • Founded: 2010 • Location: Pittsburgh • Development efforts: Mostly outsourced

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nsituvue says its investigational SFC 1000 caddy-based ultrasound system could simplify hospital practices by transitioning routine responsibility for performing vascular access procedures from a specialized team to a patient’s nurse.

At least that is the feedback the Pittsburgh-based startup has received so far.

“We’ve had medical executives at large facilities [who have looked at] this and said it has the potential to eliminate specialized IV teams,” said Gary Rosensteel, Insituvue’s executive VP. “Nurses in the units will be able to do these procedures themselves.”

The firm, which plans a 510(k) submission by year-end for the device, emphasizes the simplicity of the product, which is designed to aid tasks such as placing a peripherally inserted central catheter or an intravenous line.

A researcher tests an alpha prototype of Insituvue’s caddybased ultrasound system, which uses imaging to aid vascular access procedures. (Photo: Insituvue) According to Rosensteel, one of the central marketing advantages for the SFC 1000 will be its ability to project an ultrasound image directly over the site on which the vascular procedure will be performed, rather than on a monitor.

Practitioners “don’t have to look away, so they can go in with their needle stick, just going, pointing and shooting at the image they see right in front of them,” he explained.

It works using Insituvue’s proprietary Sonic Flashlight technology, in which a display screen residing in a transducer probe projects the ultrasound image onto a see-through mirror. This pushes the image “directly in [clinicians’] line of sight at the point of the procedure,” Rosensteel said.

The system consists of a rechargeable battery-powered caddy unit that can be carried to the patient from a plugged-in cart where the unit docks. The transducer probe docks inside the caddy unit and is connected to the unit via cable.

Insituvue is also developing a fully-handheld device called the SFH 5000.

A researcher tests an alpha prototype of Insituvue’s cart-based ultrasound system, which uses imaging to aid vascular access procedures.

Many Efforts Are Outsourced; Acquirer Sought To support the firm’s 510(k) submission, a CE mark filing in Europe planned for early next year and new product development, Insituvue is in the midst of a “Series A” venture round with a funding goal of $2.5 million. The firm expects to raise at least $1 million of that amount before the end of June.

The 510(k) is not expected to require clinical data, although prototypes of the technology have been tested on some patients at the University of Pittsburgh. The firm plans to support the CE mark with data collected as part of routine use of the device in the U.S., where several facilities have lined up to use the system, Rosensteel said.

“We can show somebody how to use the device in 15 minutes” – Insituvue’s Rosensteel Insituvue, with only three employees, is aiming to keep its infrastructure very small by outsourcing all of its electronics and software engineering, product design, and regulatory and quality-control work to contractors.

Once SFC 1000 is cleared, manufacturing will be handled by a separate Singapore-based company recently founded by Rosensteel and Insituvue CEO Karl Im. Insituvue will also work with distribution partners to sell the system.

The goal is for Insituvue to be purchased by a larger company with a few years. “We already have some discussions underway with potential acquirers,” Rosensteel said.

Keeping Things Simple To Stand Out Insituvue’s corporate structure mirrors its approach to developing the SFC 1000: In both cases a defining philosophy appears to be, ‘keep it simple.’

Large-cart and portable ultrasound devices, made by firms

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including GE Healthcare, Siemens and Philips, are prevalent on the market.

But those devices “are built in one-size-fits-all models,” Rosensteel said. And, he points out, those products are designed to perform multiple functions, requiring training to handle “so many different settings and controls.”

Insituvue’s device, on the other hand, is designed expressly for the vascular access market, where “ultrasound has not been used to a huge extent,” he said.

Because of that targeted focus, the device only needs a limited feature set so it can be “very easy to use and understand,” the executive explained.

“We can show somebody how to use the device in 15 minutes,” Rosensteel said. “It is pretty much, pick it up, turn it on and go.”

The estimated cost for the SFC 1000 cart, caddy and probe will retail about $12,000, which is “less than half of the nextlowest-cost unit,” he claimed.

D igital H ealth I n B rief Mobile messaging impact on HIV testing in South Africa

Motivational messages sent via cell phone were more successful in encouraging recipients to have an HIV test than were strictly informational messages sent via cell phone, according to randomized clinical trials conducted in South Africa, said Peter Benjamin, managing director of CellLife, a nonprofit that develops technical systems for the health sector. Benjamin gave a presentation on Cell-Life’s Cellphones 4 HIV mobile messaging project during a June 6 webinar from Cape Town, South Africa, co-sponsored by the mHealth Alliance. (See “Mobile Health Requires Validation To Reach Critical Mass – Bill Gates” – “The Gray Sheet” Nov. 15, 2010.)

ResMed mobile app for sleep assessment

Medical device maker ResMed, which markets a range of sleep therapy systems for patient and clinical use, recently introduced its ResMed Sleep Assessment mobile application for use on the iPhone mobile platform.

The app uses a snore recorder and a clinically validated questionnaire to help measure a person’s risk of sleep apnea.

The self-assessment tool is not 510(k)cleared and does not stand in for clinical diagnosis by a health care professional, a spokesperson for the company noted.

MIT, industry team up for MEDRC

GE Global Research, Analog Devices Inc. and the Massachusetts

26 | June 13, 2011

Institute of Technology have created the Medical Electronic Device Realization Center to create prototype devices and intellectual property that can act as catalysts to reduce health care costs in the developed and developing worlds, the parties said May 24. “A radical change is taking place in how medical care is being delivered, with delivery moving to ‘point of care’ rather than having patients travel to a doctor’s office or hospital,” said MEDRC co-founder Charles Sodini, LeBel professor of electrical engineering at MEDRC. The Cambridge, Mass., center will be led by Brian W. Anthony, director of the master of engineering in manufacturing program, and Joel Voldman, associate professor of electrical engineering and computer science, both at MIT.

Heart-rate-monitoring car seat under development

Engineers with Ford Motor Co. working with the RheinischWestfälische Technische Hochschule Aachen University in Germany have developed a car seat with built-in electronic sensors that can monitor a driver’s heart rate through many types of clothing. According to the auto maker, the company is researching how data collected by the sensors could be analyzed by onboard computer software or linked to remote medical monitoring services. The May 24 announcement

closely follows a May 18 media event at Ford headquarters in Dearborn, Mich., unveiling a research project on health and wellness applications for vehicles equipped with Ford’s SYNC voice-activated communications system. (See “Medtronic Teams With Ford To Explore In-Vehicle Mobile Health Concepts” – “The Gray Sheet” May 23, 2011.)

CellScope named to mobile health accelerator program A start-up called CellScope, whose mission is to bring medical microscopy to the mobile phone platform, is one of 11 start-ups selected to participate in an inaugural digital health accelerator program sponsored by the seed accelerator Rock Health. (See “Health apps incubator” – “The Gray Sheet” April 18, 2011.) Led by Daniel A. Fletcher, a professor of bioengineering at University of California, Berkley, CellScope aims to link high-resolution microscopic imaging with clinical expertise through microscopyenabled cell phones, the company says on its website.

Other health and wellness startups chosen for the technology incubator program include BrainBot, Genomera, Health In Reach, Omada Health, Pipette, Skimble and WeSprout, plus “three additional start-ups in stealth mode,” Rock Health said in a June 2 press release.

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FDA Recalls List – June 8, 2011 CLASS I Vitek 2 Gram Negative Susceptibility Card The cards are intended for use with the Vitek 2 systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic/anaerobic gram-negative bacilli to antimicrobial agents.

Manufacturer:

Biomerieux Inc., Hazelwood, MO.

Recalled by:

Manufacturer, by letter dated March 30, 2011, and April 4, 2011, and by press release on April 8, 2011. Firm-initiated recall is ongoing.

Distribution:

Canada and Sweden; 3,493 boxes as of 3/31/11 were distributed.

Reason:

The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional seven organisms; and the same drug is providing false resistant results for K. pneumoniae.

Recall numbers:

Z-2049/2050-2011.

CLASS II AC Power Adaptor (Transformer) Manufacturer:

Medela Inc., McHenry, IL.

Recalled by:

Manufacturer, by letter dated April 4, 2011. FDA-initiated recall is ongoing.

Distribution:

Nationwide and internationally; 17,681 units alone, 461,142 units with product were distributed.

Reason:

The power adaptor (transformer) used with the Pump In Style Advanced family of breast pumps have power cords that may easily become damaged if not properly handled.

Recall number:

Z-2386-2011.

Acuson S2000 Ultrasound System Manufacturer:

Siemens Medical Solutions USA Inc., Mountain View, CA.

Recalled by:

Manufacturer, by letter on March 15, 2011. Firm-initiated recall is ongoing.

Distribution:

Nationwide and internationally; 1,533 units were distributed.

Reason:

The firm discovered a software error on the Accuson S2000 ultrasound systems affecting the measurement results in the patient report.

Recall number:

Z-2051-2011.

Cell-Dyn Shear Valve Assembly Designed for in vitro diagnostic use in clinical laboratories.

Manufacturer:

Abbott Laboratories, Santa Clara, CA.

Recalled by:

Manufacturer, by letters on March 15, 2011. Firm-initiated recall is ongoing.

Distribution:

Nationwide and internationally; 170 instruments were distributed.

Reason:

The nylon washer has an outer diameter which is undersized, resulting in the inability to generate patient results.

Recall numbers:

Z-2014/2020-2011.

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CLASS II Inter x 5002 Device, Inter x Professional Sport Device, Inter x 1000 Personal Device and InterX Personal Sport packaged with Triad Alcohol Wipes Manufacturer:

H & P Industries Inc., Hartland, WI.

Recalled by:

Neuro Resource Group Inc., Plano, TX, by press release on Feb. 7, 2011, and by e-mail on March 2, 2011. Firm-initiated recall is ongoing.

Distribution:

Nationwide and internationally; 57,252 units.

Reason:

Product package contains alcohol prep pads recalled by Triad Group because the prep pads have the potential to be contaminated with an objectionable organism.

Recall number:

Z-2105-2011.

Lubricating Jelly Manufacturer:

H & P Industries, Inc., Hartland, WI.

Recalled by:

DeRoyal Processing Center, New Tazewell, TN, by letter dated March 18, 2011. Firm-initiated recall is ongoing.

Distribution:

Nationwide; 323,400 units were distributed.

Reason:

Possible contamination due to sterilization issue. Inspection of contract manufacturer found cGMP deficiencies.

Recall number:

Z-2013-2011.

Rapid Response HUT (Head Up Tilt) Table Used in clinical and hospital settings by trained radiologists.

Manufacturer:

Medical Positioning Inc., Kansas City, MO.

Recalled by:

Manufacturer, by letter on Feb. 1, 2010. Firm-initiated recall is complete.

Distribution:

Nationwide and Canada; 58 units were distributed.

Reason:

The tilt tables work intermittently and some have become stuck in an inclined or reclined position during procedures.

Recall numbers:

Z-1973/1975-2011.

S8-3t Micro TEE Transducer Indicated for adult cardiac, pediatric cardiac and transesophageal uses.

Manufacturer:

Philips Medical Systems North America Co., Phillips, Bothell, WA.

Recalled by:

Philips Medical Systems Nederlands, Best, Netherlands, by letter on March 28, 2011. Firm-initiated recall is ongoing.

Distribution:

Nationwide and internationally; 155 units were distributed.

Reason:

Users of the Philips model S8-3t Micro TEE Transducer have reported that significant image quality degradation may occur after a number of use/cleaning cycles. If users do not inspect the transducer for such damage prior to each use, imaging may not always be available, which could pose a risk for patients.

Recall number:

Z-2062-2011.

Sarns Flexible Weighted Sucker Indicated for stationary use to remove excess fluid from the surgical field.

Manufacturer:

Terumo Cardiovascular Systems Corp., Ann Arbor, MI.

Recalled by:

Manufacturer, by letter dated unknown.

Distribution:

Nationwide and internationally; 11,690 units were distributed.

Reason:

The firm has received two reports of the Terumo Weighted Flexible Sucker becoming ensnared in cardiac tissue after it was inserted into a ventricle through a valve. The firm has determined that the product’s instructions for use are inadequate; the product should not be used to drain a cardiac chamber or inserted through a valve. However this is not stated in the IFU. The firm is conducting this recall to inform users of the hazards associated with using the weighted sucker to drain a cardiac chamber or placing it through a valve.

Recall numbers:

28 | June 13, 2011

Z-2001/2012-2011.

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CLASS II SoftPerm (Synergicon A) Daily Wear Contact Lenses Manufacturer:

CIBA Vision Puerto Rico Inc., Cidra, PR.

Recalled by:

Manufacturer, by letters dated June 2010 and Feb. 1, 2011. Firm-initiated recall is ongoing.

Distribution:

Nationwide and internationally; 28,124 units were distributed.

Reason:

Out of specification values were obtained for sterility testing. The pH of the saline solution may be higher than the spec (up to pH 8.6 compared to a spec limit of pH 7.8). The osmolarity of the saline solution may be lower than specification (263 mOsm/kg compared to a spec limit of 270).

Recall number:

Z-1976-2011.

UVAR XTS Procedural Kits Indicated for use in ultraviolet-A (UVA) irradiation.

Manufacturer:

Therakos Inc., Raritan, NJ.

Recalled by:

Manufacturer, by letter dated Feb. 1, 2011. Firm-initiated recall is ongoing.

Distribution:

Nationwide and internationally; 4,323 kits were distributed.

Reason:

Therakos received an increased rate of complaints of centrifuge bowl leaks for certain lots of Therakos UVAR XTS procedural kits.

Recall number:

Z-2067-2011.

XiO Radiation Treatment Planning System Manufacturer:

Computerized Medical Systems Inc., Maryland Heights, MO.

Recalled by:

Manufacturer, by letters beginning September 2010. Firm-initiated recall is ongoing.

Distribution:

Nationwide and internationally; 1,377 units were distributed.

Reason:

XiO software is not transferring the correct information regarding coordinates for the radiation beam. The coordinates may not be accurate. If all the information is transferred at once, the information appears to be correct. If something is changed, edited, or the information is transmitted in parts, the coordinate information may not be accurate. Two patients were mistreated.

Recall number:

Z-2408-2011.

Xpert Infinity Software V 4.1a Manufacturer:

Cepheid, Sunnyvale, CA.

Recalled by:

Manufacturer, by letter dated April 13, 2011. Firm-initiated recall is ongoing.

Distribution:

Nationwide and internationally; 19 units were distributed.

Reason:

A mismatch of Patient ID or Sample ID and the Host Order from the hosted LIS and its requested test results could occur when running in batch mode and cartridges are introduced in rapid succession.

Recall number:

Z-2401-2011.

CLASS III Drainage Bag Manufacturer:

Remington Medical Inc., Alpharetta, GA.

Recalled by:

Manufacturer, by letter dated Jan. 12, 2011. Firm-initiated recall is ongoing.

Distribution:

Nationwide; 89,294 units were distributed.

Reason:

There have been complaints of the drainage bags leaking from the outlet and the inlet port.

Recall number:

Z-2405-2011.

EDITORS’ NOTE: Tabulation prepared from information provided by FDA. The agency has three classes of recalls. Class I - violative product poses reasonable probability of serious adverse health consequences or death; Class II - violative product may cause temporary or medically reversible adverse health consequences; probability of serious consequences remote; Class III - violative product not likely to cause adverse health consequences.

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FDA’s April 2011 Report of Medical Device Approvals Premarket Approvals Trade Name [App. No.]:

Cobas HPV Test [P100020]

Applicant/Date Approved:

Roche Molecular Systems Inc., Pleasanton, CA; 4/19/11

Description:

Approval for the Cobas HPV Test, a qualitative in vitro test for the detection of Human Papillomavirus (HPV) in patient specimens. The test utilizes amplification of target DNA by Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies types HPV 16 and HPV 18 while concurrently detecting the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). The cobas HPV Test is indicated: 1) To screen patients 21 years and older with ASC-US (atypical squamous cells of undetermined significance) cervical cytology test results to determine the need for referral to colposcopy; and 2) For patients 21 years and older with ASC-US cervical cytology results, to assess the presence or absence of high-risk HPV genotypes 16 and 18. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy; 3) In women 30 years and older, the Cobas HPV test can be used with cervical cytology to adjunctively screen to assess the presence or absence of high risk HPV types. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management; and 4) In women 30 years and older, the Cobas HPV test can be used to assess the presence or absence of HPV genotypes 16 and 18. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. Cervical specimens that may be tested with the Cobas HPV test include the following liquid based collection media and collection device: a) ThinPrep Pap Test PreserCyt Solution; and b) Endocervical Brush/Spatula.

Trade Name [App. No.]:

ION Paclitaxel-Eluting Coronary Stent System (Monorail and Over-The-Wire Systems) [P100023]

Applicant/Date Approved:

Boston Scientific Corp., Maple Grove, MN; 4/22/11

Description:

Approval for the ION Paclitaxel-eluting coronary stent system. This device is indicated for improving luminal diameter for the treatment of de novo lesions in native coronary arteries ≥ 2.25 mm to <4.00 mm in diameter in lesions < 34 mm in length.

Trade Name [App. No.]:

NovoTTF-100A System [P100034]

Applicant/Date Approved:

NovoCure Ltd., Rye Beach, NH; 4/8/11

Description:

Approval for the NovoTTF-100A System. The device is indicated for treatment of adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme, following histologically- or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.

Trade Name [App. No.]:

Pipeline Embolization Device [P100018]

Applicant/Date Approved:

Covidien/ev3 Inc., Menlo Park, CA; 4/6/11

Description:

Approval for the Pipeline embolization device. This device is indicated for the endovascular treatment of adults (age 22 and above) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments.

Trade Name [App. No.]:

St. Jude Medical Trifecta Valve [P100029]

Applicant/Date Approved:

St. Jude Medical, St. Paul, MN; 4/20/11

Description:

Approval for the St. Jude Medical Trifecta Valve. The Trifecta Valve is intended as a replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic heart valve.

30 | June 13, 2011

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Premarket Approvals Trade Name [App. No.]:

Valiant Thoracic Stent Graft with the Captivia Delivery System [P100040]

Applicant/Date Approved:

Medtronic Vascular, Santa Rosa, CA; 4/1/11

Description:

Approval for the Valiant Thoracic Stent Graft with the Captivia Delivery System. This device is indicated for the endovascular repair of fusiform aneurysms and saccular aneurysms/penetrating ulcers of the descending thoracic aorta in patients having appropriate anatomy, including: 1) iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories; 2) non-aneurysmal aortic diameter in the range of 18-42 mm; and 3) non-aneurysmal aortic proximal and distal neck lengths > 20 mm.

Trade Name [App. No.]:

1782 Tendril Leads [P960013/S064]

Applicant/Date Approved:

St. Jude Medical Inc., Sylmar, CA; 4/6/11

Description:

Addition of an alternate supplier for the connector ring crimp core.

Trade Name [App. No.]:

Activa Implantable Neurostimulators [P960009/S090]

Applicant/Date Approved:

Medtronic Neuromodulation, Minneapolis, MN; 4/22/11

Description:

Approval for minor design changes to the L283 multi- function integrated circuit contained in the neurostimulators of the devices.

Trade Name [App. No.]:

Activa Implantable Neurostimulators [P960009/S113]

Applicant/Date Approved:

Medtronic Neuromodulation, Minneapolis, MN; 4/29/11

Description:

Implementation of manufacturing changes for Activa devices.

Trade Name [App. No.]:

Acuity Spiral Leads and Lead Stabilizer Accessory [P010012/S264]

Applicant/Date Approved:

Boston Scientific, St. Paul, MN; 4/7/11

Description:

Approval for reassignment of a mechanical input specification, Suture Sleeve Resistance to Cut-Through from the suture sleeve, to the lead body for the Acuity spiral implantable lead.

Trade Name [App. No.]:

Acuity Steerable Leads [P050046/S010]

Applicant/Date Approved:

Boston Scientific Corp., St. Paul, MN; 4/29/11

Description:

Change in biological indicator model used as part of the manufacturing process.

Trade Name [App. No.]:

Adapta, Versa, Sensia, Relia IPGs [P980035/S208]

Applicant/Date Approved:

Medtronic Inc., Mounds View, MN; 4/4/11

Description:

Upgrades to test system hardware and software.

Trade Name [App. No.]:

Adiana Permanent Contraception System [P070022/S016]

Applicant/Date Approved:

Hologic Inc., Marlborough, MA; 4/14/11

Description:

Change in inspection procedure.

Trade Name [App. No.]:

Adiana Permanent Contraception System [P070022/S017]

Applicant/Date Approved:

Hologic Inc., Marlborough, MA; 4/8/11

Description:

Implementation of a microbiology laboratory.

Trade Name [App. No.]:

Advisa DR A4DR01 Implantable Pulse Generator and Model 9995 Application Software v7.3 [P980035/S134]

Applicant/Date Approved:

Medtronic Inc., Mounds View, MN; 4/4/11

Description:

Approval for the Advisa DR A4DR01 implantable pulse generator, Model 9995 application software v7.3, CareLink monitor model 2490G upgrade, CardioSight Reader Model 2020A upgrade, and Model 2491 DDMA upgrade.

Premarket Approval Supplements

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Premarket Approval Supplements Trade Name [App. No.]:

Affinity/Integrity/Victory Family of Pacemakers [P880086/S195]

Applicant/Date Approved:

St. Jude Medical, Sunnyvale, CA; 4/4/11

Description:

Approval for Model 3330 Version 12.1 Software for the Model 3650 Merlin patient care system.

Trade Name [App. No.]:

Akreos Posterior Chamber Intraocular Lens [P060022/S008]

Applicant/Date Approved:

Bausch & Lomb, Aliso Viejo, CA; 4/29/11

Description:

Approval to implement the proposed change to the bioburden testing for the Akreos posterior chamber intraocular lens.

Trade Name [App. No.]:

Alair Bronchial Thermoplasty System [P080032/S006]

Applicant/Date Approved:

Boston Scientific Corp., Sunnyvale, CA; 4/7/11

Description:

Approval of the post-approval study protocol.

Trade Name [App. No.]:

Amplatzer Duct Occluder [P020024/S033]

Applicant/Date Approved:

AGA Medical Corp., Plymouth, MN; 4/8/11

Description:

Modifications to pouch sealing equipment.

Trade Name [App. No.]:

Amplatzer Muscular VSD Occluder [P040040/S018]

Applicant/Date Approved:

AGA Medical Corp., Plymouth, MN; 4/8/11

Description:

Modifications to pouch sealing equipment.

Trade Name [App. No.]:

Amplatzer Septal Occluder [P000039/S041]

Applicant/Date Approved:

AGA Medical Corp., Plymouth, MN; 4/8/11

Description:

Modifications to pouch sealing equipment.

Trade Name [App. No.]:

AneuRx AAAdvantage Stent Graft with Xcelerant Hydro Delivery System [P990020/S043]

Applicant/Date Approved:

Medtronic Vascular, Santa Rosa, CA; 4/12/11

Description:

Approval to extend the scope of the receiving and manufacturing activities conducted at a third party storage location.

Trade Name [App. No.]:

AngioJet Rheolytic Thrombectomy System [P980037/S035]

Applicant/Date Approved:

Medrad Inverventional/Possis, Minneapolis, MN; 4/7/11

Description:

Approval for changes to the AngioJet Ultra XMI Thrombectomy Set TruSeal Introducer.

Trade Name [App. No.]:

AngioSculpt PTCA Scoring Balloon Catheter, Easy Exchange [P050018/S013]

Applicant/Date Approved:

Angioscore Inc., Fremont, CA; 4/8/11

Description:

Addition of an inflation lumen inspection.

Trade Name [App. No.]:

Angio-Seal Vascular Closure Device [P930038/S066]

Applicant/Date Approved:

St. Jude Medical, St. Paul, MN; 4/8/11

Description:

Elimination of a component cleaning.

Trade Name [App. No.]:

Apligraf (Graftskin) [P950032/S063]

Applicant/Date Approved:

Organogenesis Inc., Canton, MA; 4/6/11

Description:

Approval for the introduction of keratinocyte cell strain (HEP071) into the manufacture of Apligraf.

32 | June 13, 2011

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‘‘The Gray Sheet’’

http://TheGraySheet.ElsevierBI.com

®

Premarket Approval Supplements Trade Name [App. No.]:

Architect Ausab [P050051/S007]

Applicant/Date Approved:

Abbott Labs, Abbott Park, IL; 4/4/11

Description:

Approval for a manufacturing site located at Abbott Ireland Diagnostics Division in Sligo, Ireland.

Trade Name [App. No.]:

Architect Ausab [P050051/S005]

Applicant/Date Approved:

Abbott Labs, Abbott Park, IL; 4/4/11

Description:

Approval for a manufacturing site located at Abbott Ireland Diagnostics Division in Sligo, Ireland and a manufacturing site at Abbott Diagnostics Division, Murex Biotech Ltd. in Kent, United Kingdom.

Trade Name [App. No.]:

Architect HBsAg and Architect HBsAg Confirmatory Assays [P060007/S012]

Applicant/Date Approved:

Abbott Labs, Abbott Park, IL; 4/21/11

Description:

Test method conversions, raw material and vendor changes.

Trade Name [App. No.]:

Architect HBsAg and HBsAg Confirmatory [P060007/S004]

Applicant/Date Approved:

Abbott Labs, Abbott Park, IL; 4/4/11

Description:

Approval for a manufacturing site located at Abbott Ireland Diagnostics Division in Sligo, Ireland.

Trade Name [App. No.]:

Arctic Front Cardiac CryoAblation Catheters [P100010/S002]

Applicant/Date Approved:

Medtronic CryoCath LP, Pointe Claire, Quebec, Canada; 4/1/11

Description:

Approval for a design modification of the thermocouple wire bonding to the guidewire lumen.

Trade Name [App. No.]:

Arctic Front Cardiac CryoAblation Catheters [P100010/S004]

Applicant/Date Approved:

Medtronic CryoCath LP, Pointe Claire, Quebec, Canada; 4/8/11

Description:

Approval for a design modification of guide wire lumen materials.

Trade Name [App. No.]:

Attain Ability Left Ventricular Lead [P080006/S005]

Applicant/Date Approved:

Medtronic CRDM, Mounds View, MN; 4/29/11

Description:

Approval for a shelf life extension from 6 to 24 months.

Trade Name [App. No.]:

Attain Ability Plus Lead [P080006/S002]

Applicant/Date Approved:

Medtronic Inc., Mounds View, MN; 4/1/11

Description:

Approval for the Attain Ability Plus model 4296 lead.

Trade Name [App. No.]:

AutoDelfia hAFP [P970037/S005]

Applicant/Date Approved:

PerkinElmer Inc., Indianapolis, IN; 4/8/11

Description:

Change in a raw material used in the manufacture of the Enhancement Solution auxiliary reagent used with the AutoDelfia hAFP kit.

Trade Name [App. No.]:

AxSym Anti-HCV [P970027/S013]

Applicant/Date Approved:

Abbott Labs, Abbott Park, IL; 4/15/11

Description:

Approval for a manufacturing site located at Abbott Ireland Diagnostics Division in Sligo, Ireland.

Trade Name [App. No.]:

AxSym AUSAB [P060003/S008]

Applicant/Date Approved:

Abbott Labs, Abbott Park, IL; 4/15/11

Description:

Approval for a manufacturing site located at Abbott Ireland Diagnostics Division in Sligo, Ireland.

Unauthorized photocopying is prohibited by law.

June 13, 2011 | 33

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Premarket Approval Supplements Trade Name [App. No.]:

AxSym Core 2.0 [P060012/S006]

Applicant/Date Approved:

Abbott Labs, Abbott Park, IL; 4/15/11

Description:

Approval for a manufacturing site located at Abbott Ireland Diagnostics Division in Sligo, Ireland.

Trade Name [App. No.]:

AxSym Core 2.0 [P060012/S007]

Applicant/Date Approved:

Abbott Labs, Abbott Park, IL; 4/21/11

Description:

Approval for a change of test method with a different assay for determining antibody to hepatitis B virus core antigen specific activity and allowing for use of High Titer IgG and Low Titer IgG in place of each other when their concentrations overlap.

Trade Name [App. No.]:

AxSym Core-M 2.0 [P060009/S004]

Applicant/Date Approved:

Abbott Labs, Abbott Park, IL; 4/15/11

Description:

Approval for a manufacturing site located at Abbott Ireland Diagnostics Division in Sligo, Ireland.

Trade Name [App. No.]:

AxSym Core-M 2.0 [P060009/S005]

Applicant/Date Approved:

Abbott Labs, Abbott Park, IL; 4/4/11

Description:

Changes to replace reagents for in- process testing of the HBV core antigen (anti-HBc) specific activity and to allow the use of two alternative precursors for manufacturing of the Purified Filtered HBc IgG within the Abbott Park, Illinois manufacturing facility.

Trade Name [App. No.]:

AxSym HBsAg/Confirmatory [P050049/S006]

Applicant/Date Approved:

Abbott Labs, Abbott Park, IL; 4/15/11

Description:

Approval for a manufacturing site located at Abbott Ireland Diagnostics Division in Sligo, Ireland.

Trade Name [App. No.]:

Balloon Catheter [P100010/S009]

Applicant/Date Approved:

Medtronic CryoCath LP, Pointe Claire, Quebec, Canada; 4/29/11

Description:

Transfer the gas filling and testing operations for the compressor subassembly to the supplier.

Trade Name [App. No.]:

Biocor Standard Aortic Models, Biocor Standard Mitral Models, Biocor Supra Models, Epic Standard Aortic Models, Epic Standard Mitral Models, Epic Supra Models [P040021/S014]

Applicant/Date Approved:

St. Jude Medical, St. Paul, MN; 4/1/11

Description:

Approval for a manufacturing site located at St. Jude Medical in Alajuela, Croatia.

Trade Name [App. No.]:

Bio-Rad Monolisa Anti-HBc EIA [P060031/S005]

Applicant/Date Approved:

Bio-Rad Labs Inc., Redmond, WA; 4/28/11

Description:

Change in the scale of manufacture of the Conjugate reagent component of the Bio-Rad Monolisa Anti-HBc EIA.

Trade Name [App. No.]:

Birmingham Hip Resurfacing System [P040033/S019]

Applicant/Date Approved:

Smith & Nephew Orthopaedics, Memphis, TN; 4/1/11

Description:

Approval of the post-approval study protocol.

Trade Name [App. No.]:

BV1% OVD (1% Sodium Hyaluronate Viscoelastic Surgical Aid Fluid) [P960011/S019]

Applicant/Date Approved:

Ferring Pharmaceuticals Inc., Parsippany, NJ; 4/1/11

Description:

Alternate rheometer for testing in-process control and finished product samples.

34 | June 13, 2011

© 2011 F-D-C Reports, Inc., an Elsevier company. All rights reserved.

‘‘The Gray Sheet’’

http://TheGraySheet.ElsevierBI.com

®

Premarket Approval Supplements Trade Name [App. No.]:

Cadence Family of ICDs [P910023/S254]

Applicant/Date Approved:

St. Jude Medical, Sunnyvale, CA; 4/4/11

Description:

Approval for Model 3330 Version 12.1 Software for the Model 3650 Merlin Patient Care System.

Trade Name [App. No.]:

Cadence ICDs [P910023/S253]

Applicant/Date Approved:

St. Jude Medical, Sunnyvale, CA; 4/25/11

Description:

Approval for an alternate supplier for the RF antenna module.

Trade Name [App. No.]:

CareLink Monitor, CardioSight Reader and Device Data Management Application (DDMA) [P890003/S169]

Applicant/Date Approved:

Medtronic Inc., Mounds View, MN; 4/4/11

Description:

Approval for the Advisa DR A4DR01 Implantable Pulse Generator, Model 9995 Application Software v7.3, CareLink Monitor Model 2490G upgrade, CardioSight Reader Model 2020A upgrade, and Model 2491 DDMA upgrade.

Trade Name [App. No.]:

CareLink Remote Home Monitor and CardioSight Reader [P890003/S217]

Applicant/Date Approved:

Medtronic Inc., Mounds View, MN; 4/6/11

Description:

The transfer of final device packaging inspection activities.

Trade Name [App. No.]:

Celsius ThermoCool, Celsius RMT ThermoCool, NaviStar, NaviStar RMT, EZ Steer, EZ Steer Nav Catheters [P030031/S032]

Applicant/Date Approved:

Biosense Webster Inc., Diamond Bar, CA; 4/6/11

Description:

Addition of a second qualified chamber for the sterilization process.

Trade Name [App. No.]:

Celsius, RMT, EZ Steer, EZ Steer DS Non-Temperature Sensing Ablation Catheters [P950005/S034]

Applicant/Date Approved:

Biosense Webster Inc., Diamond Bar, CA; 4/6/11

Description:

Addition of a second qualified chamber for the sterilization process.

Trade Name [App. No.]:

Celsius, ThermoCool, Celsius RMT ThermoCool, NaviStar, NaviStar RMT, EZ Steer, EZ Steer Nav Catheters [P040036/S023]

Applicant/Date Approved:

Biosense Webster Inc., Diamond Bar, CA; 4/6/11

Description:

Addition of a second qualified chamber for the sterilization process.

Trade Name [App. No.]:

Chilli Cooled Ablation System – Chilli Tubing Kit [P980003/S025]

Applicant/Date Approved:

Boston Scientific Corp., San Jose, CA; 4/8/11

Description:

Approval for ten design changes to the CircuCool Model 8005 Pump System to address stoppage and motor noise complaints. These changes include: 1) Changing a Schotky diode from ON Semiconductor’s 1N5822 (40V maximum reverse voltage) to ON Semiconductor’s MBR360 (60V maximum reverse voltage); 2) Addition of a 33.3V voltage suppressor (ON Semiconductor P6KE39AG) across motor terminals at the motor; and 3) Dimensional and tolerance revisions to the roller sleeve, shaft rotor and roller components.

Trade Name [App. No.]:

Cochlear Nucleus 5 Cochlear Implant System [P970051/S068]

Applicant/Date Approved:

Cochlear Americas, Centennial, CO; 4/7/11

Description:

Approval for additional labeling for the CI500 Series Cochlear Implant.

Trade Name [App. No.]:

Consulta D224TRK, Concerto II D274TRK, and Maximo II D284TRK ICDs with Cardiac Resynchronization Therapy (CRT-D) [P010031/S150]

Applicant/Date Approved:

Medtronic Inc., Mounds View, MN; 4/4/11

Description:

Approval for the Advisa DR A4DR01 Implantable Pulse Generator, Model 9995 Application Software v7.3, CareLink Monitor Model 2490G upgrade, CardioSight Reader Model 2020A upgrade, and Model 2491 DDMA upgrade.

Unauthorized photocopying is prohibited by law.

June 13, 2011 | 35

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Premarket Approval Supplements Trade Name [App. No.]:

Contak CD, Livian, and Cognis Families of CRT-Ds and Easytrak and Acuity Spiral Families of Leads [P010012/S266]

Applicant/Date Approved:

Boston Scientific Corp., St. Paul, MN; 4/29/11

Description:

Change in biological indicator model used as part of the manufacturing process.

Trade Name [App. No.]:

Contak Renewal TR Family of CRT-Ps [P030005/S074]

Applicant/Date Approved:

Boston Scientific Corp., St. Paul, MN; 4/29/11

Description:

Change in biological indicator model used as part of the manufacturing process.

Trade Name [App. No.]:

Contak Renewal TR CRT-Ds [P030005/S067]

Applicant/Date Approved:

Boston Scientific Corp., St. Paul, MN; 4/8/11

Description:

Approval for the addition of a receiving inspection step for setscrews on header components.

Trade Name [App. No.]:

Contak Renewal TR2 and Livian Families of CRT-Ds [P010012/S247]

Applicant/Date Approved:

Boston Scientific Corp., St. Paul, MN; 4/8/11

Description:

Approval for the addition of a receiving inspection step for setscrews on header components.

Trade Name [App. No.]:

Delta and Vista Families of Pacemakers [P840068/S049]

Applicant/Date Approved:

Boston Scientific Corp., St. Paul, MN; 4/29/11

Description:

Change in biological indicator model used as part of the manufacturing process.

Trade Name [App. No.]:

Driver and Micro-Driver Coronary Stent Systems [P030009/S050]

Applicant/Date Approved:

Medtronic Vascular, Santa Rosa, CA; 4/12/11

Description:

Approval for a change to allow the removal of the in-process functional testing completed on the stents of Driver and Micro-Driver coronary stent systems and Endeavor Sprint Zotarolimus-eluting coronary stent systems.

Trade Name [App. No.]:

Driver, Micro-Driver, and Integrity Coronary Stent Systems [P030009/S051]

Applicant/Date Approved:

Medtronic Vascular, Santa Rosa, CA; 4/12/11

Description:

Approval to extend the scope of the receiving and manufacturing activities conducted at a third party storage location.

Trade Name [App. No.]:

ELCA Coronary Atherectomy Catheters [P910001/S042]

Applicant/Date Approved:

Spectranetics Inc., Colorado Springs, CO; 4/20/11

Description:

Approval to implement the use of an automated method instead of a manual method of dispensing epoxy adhesive.

Trade Name [App. No.]:

Endeavor Sprint Zotarolimus-Eluting Coronary Stent Systems [P060033/S060]

Applicant/Date Approved:

Medtronic Vascular, Santa Rosa, CA; 4/12/11

Description:

Approval for a change to allow the removal of the in-process functional testing completed on the stents of Driver and Micro-Driver coronary stent systems and Endeavor Sprint Zotarolimus-eluting coronary stent systems.

Trade Name [App. No.]:

Endotak Family of Leads [P910073/S096]

Applicant/Date Approved:

Boston Scientific Corp., St. Paul, MN; 4/29/11

Description:

Change in biological indicator model used as part of the manufacturing process.

Trade Name [App. No.]:

Endotak Reliance Leads [P910073/S095]

Applicant/Date Approved:

Boston Scientific Corp.–CRM, St. Paul, MN; 4/29/11

Description:

Make BSC the primary supplier of the 4-SITE lead terminal assembly.

36 | June 13, 2011

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‘‘The Gray Sheet’’

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®

Premarket Approval Supplements Trade Name [App. No.]:

Epic HF CRT-Ds [P030054/S176]

Applicant/Date Approved:

St. Jude Medical, Sunnyvale, CA; 4/25/11

Description:

Approval for an alternate supplier for the RF antenna module.

Trade Name [App. No.]:

Epic HF/Atlas+HF Family of CRT-Ds [P030054/S177]

Applicant/Date Approved:

St. Jude Medical, Sunnyvale, CA; 4/4/11

Description:

Approval for Model 3330 Version 12.1 Software for the Model 3650 Merlin Patient Care System.

Trade Name [App. No.]:

Euflexxa (1% Sodium Hyaluronate) [P010029/S012]

Applicant/Date Approved:

Ferring Pharmaceuticals Inc., Parsippany, NJ; 4/1/11

Description:

Alternate rheometer for testing in-process control and finished product samples.

Trade Name [App. No.]:

Evia DR, DR-T, SR and SR-T, Entovis DR, DR-T, SR and SR-T, Estella DR, DR-T, SR and SR-T, Ecuro DR, DR-T, SR and SR-T and Effecta D, DR, S and SR [P950037/S094]

Applicant/Date Approved:

Biotronik Inc., Lake Oswego, OR; 4/6/11

Description:

New supplier site for the manufacture of electrical modules.

Trade Name [App. No.]:

Express SD Renal Monorail Premounted Stent System [P060006/S014]

Applicant/Date Approved:

Boston Scientific Corp., Maple Grove, MN; 4/1/11

Description:

Approval for the removal of the monthly ongoing product particulate testing at the Maple Grove manufacturing facilities.

Trade Name [App. No.]:

Express/Express 2 Coronary Stent System [P020009/S065]

Applicant/Date Approved:

Boston Scientific Corp., Maple Grove, MN; 4/1/11

Description:

Approval for the removal of the monthly ongoing product particulate testing at the Maple Grove manufacturing facilities.

Trade Name [App. No.]:

External Test Stimulator [P840001/S178]

Applicant/Date Approved:

Medtronic Neuromodulation, Minneapolis, MN; 4/4/11

Description:

Approval for minor design, manufacturing, and labeling changes to the Model 3625 External Test Stimulator in order to establish compliance with functional requirements in the harmonized standards IEC (International Electrotechnical Commission) 60601-1 and IEC 60601-1-2.

Trade Name [App. No.]:

External Test Stimulator [P960009/S108]

Applicant/Date Approved:

Medtronic Neuromodulation, Minneapolis, MN; 4/4/11

Description:

Approval for minor design, manufacturing, and labeling changes to the Model 3625 External Test Stimulator in order to establish compliance with functional requirements in the harmonized standards IEC (International Electrotechnical Commission) 60601-1 and IEC 60601-1-2.

Trade Name [App. No.]:

External Test Stimulator [P970004/S104]

Applicant/Date Approved:

Medtronic Neuromodulation, Minneapolis, MN; 4/4/11

Description:

Approval for minor design, manufacturing, and labeling changes to the Model 3625 External Test Stimulator in order to establish compliance with functional requirements in the harmonized standards IEC (International Electrotechnical Commission) 60601-1 and IEC 60601-1-2.

Trade Name [App. No.]:

EZ Steer Nav DS and Qwikstar DS Catheters [P010068/S024]

Applicant/Date Approved:

Biosense Webster Inc., Diamond Bar, CA; 4/6/11

Description:

Addition of a second qualified chamber for the sterilization process.

Unauthorized photocopying is prohibited by law.

June 13, 2011 | 37

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®

Premarket Approval Supplements Trade Name [App. No.]:

Freestyle Aortic Root Bioprosthesis [P970031/S032]

Applicant/Date Approved:

Medtronic Inc., Santa Ana, CA; 4/15/11

Description:

Approval for modifications to your secondary and tertiary packaging, including the addition of two new materials: a temperature indicator (to be placed in the secondary package) and a clear end seal label.

Trade Name [App. No.]:

Freezor, Freezor Xtra, Freezor Max Cryoablation Catheters [P020045/S038]

Applicant/Date Approved:

Medtronic CryoCath LP, Pointe Claire, Quebec, Canada; 4/29/11

Description:

Transfer the gas filling and testing operations for the compressor subassembly to the supplier.

Trade Name [App. No.]:

FreshLook (phemfilcon A) Soft Contact Lenses for Extended Wear [P830037/S052]

Applicant/Date Approved:

Ciba Vision Corp., Duluth, GA; 4/21/11

Description:

Upgrading the control system in the Finn Aqua Sterilizer FA5.

Trade Name [App. No.]:

Frontier/Frontier II Family of CRT-Ps [P030035/S075]

Applicant/Date Approved:

St. Jude Medical, Sunnyvale, CA; 4/4/11

Description:

Approval for Model 3330 Version 12.1 Software for the Model 3650 Merlin Patient Care System.

Trade Name [App. No.]:

Gore Excluder AAA Endoprosthesis [P020004/S061]

Applicant/Date Approved:

W.L. Gore & Associates, Flagstaff, AZ; 4/8/11

Description:

Automation of the trimming process during the trunk wrapping and forming step.

Trade Name [App. No.]:

Gore Viabahn Endoprosthesis and Gore Viabahn Endoprosthesis with Heparin Bioactive Surface [P040037/S033]

Applicant/Date Approved:

W.L. Gore & Associates Inc., Flagstaff, AZ; 4/20/11

Description:

Approval for changes to the sterilization process.

Trade Name [App. No.]:

Gynecare Thermachoice III Uterine Balloon Therapy System [P970021/S034]

Applicant/Date Approved:

Ethicon, Women’s Health and Urology, Somerville, NJ; 4/5/11

Description:

Manufacturing location change of a raw material supplier.

Trade Name [App. No.]:

Hancock II Porcine Bioprosthesis [P980043/S030]

Applicant/Date Approved:

Medtronic Inc., Santa Ana, CA; 4/15/11

Description:

Approval for modifications to your secondary and tertiary packaging, including the addition of two new materials: a temperature indicator (to be placed in the secondary package) and a clear end seal label.

Trade Name [App. No.]:

HercepTest [P980018/S013]

Applicant/Date Approved:

Dako Denmark A/S, Glostrup, Denmark; 4/18/11

Description:

Approval for labeling changes that add a precaution and an instruction that is intended to enhance the safe use of HercepTest.

Trade Name [App. No.]:

Hoya iSpheric Intraocular Lens [P080004/S006]

Applicant/Date Approved:

Hoya Surgical Optics Inc., Chino Hills, CA; 4/7/11

Description:

Changes to the previously approved test laboratory and to the LAL test method.

Trade Name [App. No.]:

Immulite/Immulite 2000 AFP [P010007/S005]

Applicant/Date Approved:

Siemens Healthcare Diagnostics, Tarrytown, NY; 4/26/11

Description:

Approval for introduction of a new instrument model Immulite 2000 XPi Analyzer, as a family member of the currently cleared Immulite 2000 Analyzer.

38 | June 13, 2011

© 2011 F-D-C Reports, Inc., an Elsevier company. All rights reserved.

‘‘The Gray Sheet’’

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®

Premarket Approval Supplements Trade Name [App. No.]:

Immulite/Immulite 2000 Free PSA [P060005/S004]

Applicant/Date Approved:

Siemens Healthcare Diagnostics, Tarrytown, NY; 4/26/11

Description:

Approval for introduction of a new instrument model Immulite 2000 XPi Analyzer, as a family member of the currently cleared Immulite 2000 Analyzer.

Trade Name [App. No.]:

Immulite/Immulite 2000 PSA [P930027/S011]

Applicant/Date Approved:

Siemens Healthcare Diagnostics, Tarrytown, NY; 4/26/11

Description:

Approval for introduction of a new instrument model Immulite 2000 XPi Analyzer, as a family member of the currently cleared Immulite 2000 Analyzer.

Trade Name [App. No.]:

Infuse Bone Graft [P000054/S027]

Applicant/Date Approved:

Medtronic Sofamor Danek, Memphis, TN; 4/4/11

Description:

Approval for an additional source of recombinant insulin.

Trade Name [App. No.]:

Infuse Bone Graft [P050053/S018]

Applicant/Date Approved:

Medtronic Sofamor Danek, Memphis, TN; 4/4/11

Description:

Approval for an additional source of recombinant insulin.

Trade Name [App. No.]:

Infuse Bone Graft/LT-Cage Lumbar Tapered Fusion [P000058/S040]

Applicant/Date Approved:

Medtronic Sofamor Danek, Memphis, TN; 4/4/11

Description:

Approval for an additional source of recombinant insulin.

Trade Name [App. No.]:

Insignia Pulse Generators [D970003/S122]

Applicant/Date Approved:

Boston Scientific Corp., St. Paul, MN; 4/8/11

Description:

Approval for the addition of a receiving inspection step for setscrews on header components.

Trade Name [App. No.]:

Interface Cables [P990071/S012]

Applicant/Date Approved:

Biosense Webster Inc., Diamond Bar, CA; 4/6/11

Description:

Addition of a second qualified chamber for the sterilization process.

Trade Name [App. No.]:

Latitude Communicator [P910077/S112]

Applicant/Date Approved:

Boston Scientific Corp., St. Paul, MN; 4/29/11

Description:

Rework of Printed Circuit Assemblies (PCAs) used in the manufacture of the Latitude Communicator.

Trade Name [App. No.]:

LifeVest Wearable Defibrillator WCD 4000 [P010030/S023]

Applicant/Date Approved:

Zoll Lifecor Corp., Pittsburgh, PA; 4/19/11

Description:

Approval for updated bare board artwork for use in the LifeVest Wearable Defibrillator WCD 4000.

Trade Name [App. No.]:

Maxum System [P010023/S004]

Applicant/Date Approved:

Ototronix LLC, St. Paul, MN; 4/8/11

Description:

Approval for the change to a digital processor in the external integrated processor and coil (IPC). The Maxum Digital IPC replaces the analog processor with a standard commercial digital processor intended for hearing aid use.

Trade Name [App. No.]:

Medtronic Endeavor Sprint Zotarolimus-Eluting Coronary Stent Systems [P060033/S061]

Applicant/Date Approved:

Medtronic Vascular, Santa Rosa, CA; 4/12/11

Description:

Approval to extend the scope of the receiving and manufacturing activities conducted at a third party storage location.

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June 13, 2011 | 39

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Elsevier Business Intelligence

®

Premarket Approval Supplements Trade Name [App. No.]:

Medtronic Endeavor Zotarolimus-Eluting Coronary Stent System [P060033/S063]

Applicant/Date Approved:

Medtronic Vascular, Santa Rosa, CA; 4/20/11

Description:

Approval for a modification to the regulatory elution specification. The device, as modified, will be marketed under the trade name Medtronic Endeavor Zotarolimus-eluting coronary stent system and is indicated for improving luminal diameter.

Trade Name [App. No.]:

Microny Family of Pacemakers [P970013/S038]

Applicant/Date Approved:

St. Jude Medical, Sunnyvale, CA; 4/4/11

Description:

Approval for Model 3330 Version 12.1 Software for the Model 3650 Merlin Patient Care System.

Trade Name [App. No.]:

Monolisa Anti-HBs EIA [P050048/S004]

Applicant/Date Approved:

Bio-Rad Technologies, Redmond, WA; 4/25/11

Description:

Approval for use of the Monolisa Anti-HBs EIA on the Evolis Automated Microplate System, adding lithium heparin and sodium heparin to the list of acceptable plasma specimen types, a change in the dye color in the Cutoff Calibrator, revision to the specimen storage requirements, and modification of the storage instructions for the Working Conjugate. The device, as modified, will be marketed under the trade name Monolisa Anti-HBs EIA and is indicated for the detection of antibody to hepatitis B surface antigen in human serum and EDTA, heparin, or citrated plasma.

The assay results may be used as an aide in the determination of susceptibility of hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection.

A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. The Monolisa Anti-HBs EIA is intended for manual use and with the Bio-Rad Evolis Automated Microplate System in the detection of antibody to hepatitis B surface antigen.

Trade Name [App. No.]:

Mosaic Porcine Bioprosthesis [P990064/S037]

Applicant/Date Approved:

Medtronic Inc., Santa Ana, CA; 4/15/11

Description:

Approval for modifications to your secondary and tertiary packaging, including the addition of two new materials: a temperature indicator (to be placed in the secondary package) and a clear end seal label.

Trade Name [App. No.]:

Multi-Link Vision and Multi-Link Mini-Vision OTW and RX Coronary Stent Systems [P020047/S033]

Applicant/Date Approved:

Abbott Vascular Inc., Temecula, CA; 4/8/11

Description:

Change in extruded tubing length, and a change from a manual tube cutting process to an automated process.

Trade Name [App. No.]:

Multi-Link Zeta Coronary Stent System [P970020/S062]

Applicant/Date Approved:

Abbott Vascular Inc., Temecula, CA; 4/8/11

Description:

Change in extruded tubing length, and a change from a manual tube cutting process to an automated process.

Trade Name [App. No.]:

Mynx Cadence Vascular Closure Device [P040044/S037]

Applicant/Date Approved:

AccessClosure Inc. (ACI), Mountain View, CA; 4/5/11

Description:

Approval for a minor design change to modify the advancer tube to incorporate a dual slit design at the proximal end of the advancer tube. The device, as modified, will be marketed under the trade name Mynx Cadence Vascular Closure Device and is indicated for use to seal femoral arterial access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath.

Trade Name [App. No.]:

NaviStar, RMT, EZ Steer Nav, Qwikstar Interface Cables [P990025/S028]

Applicant/Date Approved:

Biosense Webster Inc., Diamond Bar, CA; 4/6/11

Description:

Addition of a second qualified chamber for the sterilization process.

40 | June 13, 2011

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‘‘The Gray Sheet’’

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®

Premarket Approval Supplements Trade Name [App. No.]:

Neomend Progel Pleural Air Leak Sealant [P010047/S009]

Applicant/Date Approved:

Neomend Inc., Irvine, CA; 4/13/11

Description:

Approval for a manufacturing site located in Irvine, California.

Trade Name [App. No.]:

NovaSure Impedance Controlled Endometrial Ablation System [P010013/S034]

Applicant/Date Approved:

Hologic Inc., Marlborough, MA; 4/8/11

Description:

Implementation of a microbiology laboratory.

Trade Name [App. No.]:

PathVysion HER-2 DNA Probe Kit [P980024/S005]

Applicant/Date Approved:

Abbott Molecular Inc., Des Plaines, IL; 4/18/11

Description:

Approval for the implementation of process changes to the manufacture of the PathVysion HER-2 DNA Probe Kit Assay, including a new FISH DNA extraction process, and RNA reduction step, new sonication equipment, and a new amination/labeling procedure.

Trade Name [App. No.]:

Pulsar, Pulsar Max, Insignia, and Altrua Families of Pacemakers [D970003/S127]

Applicant/Date Approved:

Boston Scientific Corp., St. Paul, MN; 4/29/11

Description:

Change in biological indicator model used as part of the manufacturing process.

Trade Name [App. No.]:

Qiagen Digene Hybrid Capture 2 (HC2) HPV DNA Test Qiagen Digene Hybrid Capture 2 (HC2) High Risk HPV DNA Test [P890064/S026]

Applicant/Date Approved:

Qiagen, Gaithersburg, MD; 4/20/11

Description:

Approval for software design change of the hc2 System Suite consisting of an hc2 system software upgrade from version 2.0 to version 3.0.

Trade Name [App. No.]:

Reliaty Family of Pacing System Analyzers [P950037/S088]

Applicant/Date Approved:

Biotronik Inc., Lake Oswego, OR; 4/20/11

Description:

Approval for: 1) new display screen; 2) alternate battery; 3) modified battery cartridge; 4) modified battery contacts; 5) new firmware; 6) updated software; 7) modified control knob; 8) modified circuit boards; and 9) Technical Manual and device labeling changes.

Trade Name [App. No.]:

Renamic Programmer and Software Version PSW 1004.U [P950037/S089]

Applicant/Date Approved:

Biotronik Inc., Lake Oswego, OR; 4/15/11

Description:

Approval for the Renamic Programmer and Software Version PSW 1004.U.

Trade Name [App. No.]:

Renamic Programmer and Software Version PSW 1004.U [P000009/S042]

Applicant/Date Approved:

Biotronik Inc., Lake Oswego, OR; 4/15/11

Description:

Approval for the Renamic Programmer and Software Version PSW 1004.U.

Trade Name [App. No.]:

Renamic Programmer and Software Version PSW 1004.U [P050023/S039]

Applicant/Date Approved:

Biotronik Inc., Lake Oswego, OR; 4/15/11

Description:

Approval for the Renamic Programmer and Software Version PSW 1004.U.

Trade Name [App. No.]:

Renamic Programmer and Software Version PSW 1004.U [P070008/S019]

Applicant/Date Approved:

Biotronik Inc., Lake Oswego, OR; 4/15/11

Description:

Approval for the Renamic Programmer and Software Version PSW 1004.U.

Unauthorized photocopying is prohibited by law.

June 13, 2011 | 41

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Premarket Approval Supplements Trade Name [App. No.]:

Reply SR/DR and Esprit SR/DR Implantable Cardiac Pacemakers [P950029/S058]

Applicant/Date Approved:

Sorin CRM Inc., Plymouth, MN; 4/8/11

Description:

Update to the electronic hybrid module cleaning process.

Trade Name [App. No.]:

RES-Q and RES-Q Micron Families of Leads [P940008/S027]

Applicant/Date Approved:

Boston Scientific Corp., St. Paul, MN; 4/29/11

Description:

Change in biological indicator model used as part of the manufacturing process.

Trade Name [App. No.]:

Restore Family of Neurostimulators [P840001/S159]

Applicant/Date Approved:

Medtronic Neuromodulation, Minneapolis, MN; 4/22/11

Description:

Approval for minor design changes to the L283 multi- function integrated circuit contained in the neurostimulators of the devices.

Trade Name [App. No.]:

Revo MRI SureScan Pacing System [P090013/S006]

Applicant/Date Approved:

Medtronic Inc., Mounds View, MN; 4/15/11

Description:

Approval for the relocation of a sterilizer system and an additional BPA supplier.

Trade Name [App. No.]:

Sculptra Aesthetic (injectable poly-L-lactic acid) [P030050/S007]

Applicant/Date Approved:

Sanofi Aventis, US LLC, Bridgewater, NJ; 4/5/11

Description:

Approval of the post-approval study protocol.

Trade Name [App. No.]:

Secura DR/VR D224DRG/D224VRC, Virtuoso II DR/VR D274DRG/D274VRC and Maximo II DR/VR D284DRG/ D284 VRC Implantable Cardioverter Defibrillators (ICDs) [P980016/S187]

Applicant/Date Approved:

Medtronic Inc., Mounds View, MN; 4/4/11

Description:

Approval for the Advisa DR A4DR01 Implantable Pulse Generator, Model 9995 Application Software v7.3, CareLink Monitor Model 2490G upgrade, CardioSight Reader Model 2020A upgrade, and Model 2491 DDMA upgrade.

Trade Name [App. No.]:

Selute Lead Family [P950001/S022]

Applicant/Date Approved:

Boston Scientific Corp., St. Paul, MN; 4/29/11

Description:

Change in biological indicator model used as part of the manufacturing process.

Trade Name [App. No.]:

Sensolog/Dialog/Regency Family of Pacemakers [P880006/S070]

Applicant/Date Approved:

St. Jude Medical, Sunnyvale, CA; 4/4/11

Description:

Approval for Model 3330 Version 12.1 Software for the Model 3650 Merlin Patient Care System.

Trade Name [App. No.]:

Spot-Light HER2 CISH Kit [P050040/S002]

Applicant/Date Approved:

Life Technologies Corp., Frederick, MD; 4/29/11

Description:

Approval for changes in the product insert: 1) Manufacturing address change; 2) Copyright change from Invitrogen Corp. to Life Technologies. Invitrogen will remain the brand name and therefore is still included on the product insert and labeling; and an addition of literature references to the bibliography.

Trade Name [App. No.]:

St. Jude Mechanical Heart Valves [P810002/S073]

Applicant/Date Approved:

St. Jude Medical, St. Paul, MN; 4/8/11

Description:

Revised steam sterilization load configuration.

42 | June 13, 2011

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‘‘The Gray Sheet’’

http://TheGraySheet.ElsevierBI.com

®

Premarket Approval Supplements Trade Name [App. No.]:

Staar Surgical Implantable Collamer Lens (Visian ICL) [P030016/S018]

Applicant/Date Approved:

Staar Surgical Company, Monrovia, CA; 4/8/11

Description:

Approval for a labeling modification to reflect results from an Axial Length Post-Approval Study Protocol.

Trade Name [App. No.]:

Surpass Acetabular System [P040051/S002]

Applicant/Date Approved:

Stelkast Company, McMurray, PA; 4/22/11

Description:

Approval of the post-approval study protocol.

Trade Name [App. No.]:

Sweet Tip Rx, Sweet Picotip Rx, and Flextend Families of Leads [P960006/S030]

Applicant/Date Approved:

Boston Scientific Corp., St. Paul, MN; 4/29/11

Description:

Change in biological indicator model used as part of the manufacturing process.

Trade Name [App. No.]:

Talent Abdominal Stent Graft System [P070027/S025]

Applicant/Date Approved:

Medtronic Inc., Santa Rosa, CA; 4/19/11

Description:

Approval of the post-approval study protocol.

Trade Name [App. No.]:

Talent Abdominal Stent Graft with the Xcelerant Hydro Delivery System [P070027/S027]

Applicant/Date Approved:

Medtronic Vascular, Santa Rosa, CA; 4/12/11

Description:

Approval to extend the scope of the receiving and manufacturing activities conducted at a third party storage location.

Trade Name [App. No.]:

Talent Thoracic Stent Graft with the Xcelerant and Captivia Delivery System [P070007/S026]

Applicant/Date Approved:

Medtronic Vascular, Santa Rosa, CA; 4/12/11

Description:

Approval to extend the scope of the receiving and manufacturing activities conducted at a third party storage location.

Trade Name [App. No.]:

Tetrafilcon A [N17679/S035]

Applicant/Date Approved:

Cooper Vision Inc., Pleasanton, CA; 4/29/11

Description:

Changes in criteria for acceptance for water content from 5% to 2%, and revision to maximum specifications of lens material components and the specification for water content.

Trade Name [App. No.]:

Therakos Cellex Photopheresis System [P860003/S058]

Applicant/Date Approved:

Therakos Inc., Raritan, NJ; 4/21/11

Description:

Approval for an additional sterilization site located at Sterigenics US LLC in Charlotte, North Carolina.

Trade Name [App. No.]:

Thinline/Fineline Families of Leads [P960004/S049]

Applicant/Date Approved:

Boston Scientific Corp., St. Paul, MN; 4/29/11

Description:

Change in biological indicator model used as part of the manufacturing process.

Trade Name [App. No.]:

Universal CryoConsole [P020045/S036]

Applicant/Date Approved:

Medtronic Inc., Mounds View, MN; 4/29/11

Description:

Addition of an additional calibration, calibration equipment, and associated documentation change.

Trade Name [App. No.]:

Urologix Targis System for the Treatment of BPH [P970008/S056]

Applicant/Date Approved:

Urologix Inc., Minneapolis, MN; 4/29/11

Description:

Changes in the quality control testing.

Unauthorized photocopying is prohibited by law.

June 13, 2011 | 43

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®

Premarket Approval Supplements Trade Name [App. No.]:

UroVysion Bladder Cancer Kit [P030052/S005]

Applicant/Date Approved:

Abbott Molecular Inc., Des Plaines, IL; 4/8/11

Description:

Changes to the reference DNA manufacturing and the small scale fermentation processes.

Trade Name [App. No.]:

Ventak AV, Ventak Prizm DR/VR, Vitality, Confient and Livian Families of ICDs [P960040/S243]

Applicant/Date Approved:

Boston Scientific Corp., St. Paul, MN; 4/29/11

Description:

Change in biological indicator model used as part of the manufacturing process.

Trade Name [App. No.]:

Ventak Family of ICDs [P830060/S068]

Applicant/Date Approved:

Boston Scientific Corp., St. Paul, MN; 4/29/11

Description:

Change in biological indicator model used as part of the manufacturing process.

Trade Name [App. No.]:

Ventak P Family of ICDs [P890061/S019]

Applicant/Date Approved:

Boston Scientific Corp., St. Paul, MN; 4/29/11

Description:

Change in biological indicator model used as part of the manufacturing process.

Trade Name [App. No.]:

Ventak P2 Family of ICDs [P930035/S020]

Applicant/Date Approved:

Boston Scientific Corp., St. Paul, MN; 4/29/11

Description:

Change in biological indicator model used as part of the manufacturing process.

Trade Name [App. No.]:

Ventak PRx/Mini Families of ICDs [P910077/S113]

Applicant/Date Approved:

Boston Scientific Corp., St. Paul, MN; 4/29/11

Description:

Change in biological indicator model used as part of the manufacturing process.

Trade Name [App. No.]:

VeriFlex (Liberté) Bare Metal Coronary Stent System [P040016/S059]

Applicant/Date Approved:

Boston Scientific Corp., Maple Grove, MN; 4/1/11

Description:

Approval for the removal of the monthly ongoing product particulate testing at the Maple Grove manufacturing facilities.

Trade Name [App. No.]:

Vigor DR/SR, Discovery, and Meridian Families of Pacemakers [P940031/S071]

Applicant/Date Approved:

Boston Scientific Corp., St. Paul, MN; 4/29/11

Description:

Change in biological indicator model used as part of the manufacturing process.

Trade Name [App. No.]:

Vistakon (etafilcon A) Contact Lenses, Clear and Visibly Tinted with UV blocker [N18033/S054]

Applicant/Date Approved:

Johnson & Johnson Vision Care Inc., Jacksonville, FL; 4/7/11

Description:

Change in the sampling frequency of an in-process quality audit.

Trade Name [App. No.]:

Vitality Family of ICDs [P960040/S227]

Applicant/Date Approved:

Boston Scientific Corp., St. Paul, MN; 4/8/11

Description:

Approval for the addition of a receiving inspection step for setscrews on header components.

Trade Name [App. No.]:

Vitros Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator [P030026/S021]

Applicant/Date Approved:

Ortho Clinical Diagnostics Inc., Rochester, NY; 4/22/11

Description:

Change in the manufacturing scale of a reagent component.

44 | June 13, 2011

© 2011 F-D-C Reports, Inc., an Elsevier company. All rights reserved.

‘‘The Gray Sheet’’

http://TheGraySheet.ElsevierBI.com

®

Premarket Approval Supplements Trade Name [App. No.]:

VNS Therapy System [P970003/S124]

Applicant/Date Approved:

Cyberonics Inc., Houston, TX; 4/19/11

Description:

Revision to the test tab routing steps.

Trade Name [App. No.]:

VNS Therapy System [P970003/S125]

Applicant/Date Approved:

Cyberonics Inc., Houston, TX; 4/29/11

Description:

Modification of visual inspection acceptance criteria for three capacitors.

Trade Name [App. No.]:

Xience V and Promus Everolimus Eluting Coronary Stent System [P070015/S061]

Applicant/Date Approved:

Abbott Vascular Inc., Temecula, CA; 4/8/11

Description:

Change in extruded tubing length, and a change from a manual tube cutting process to an automated process.

Trade Name [App. No.]:

Xience V and Promus Everolimus Eluting Coronary Stent Systems [P070015/S062]

Applicant/Date Approved:

Abbott Vascular, Temecula, CA; 4/8/11

Description:

Remove redundant cleaning and treatment steps.

Trade Name [App. No.]:

Xience V and Promus Everolimus Eluting Coronary Stent Systems [P070015/S063]

Applicant/Date Approved:

Abbott Vascular, Temecula, CA; 4/8/11

Description:

Modification of cleanroom classification and gowning requirements.

Trade Name [App. No.]:

Xience V Eluting Coronary Stent System and Promus Everolimus Eluting Coronary Stent System [P070015/S066]

Applicant/Date Approved:

Abbott Vascular, Temecula, CA; 4/29/11

Description:

Modification of a sampling plan for particulate testing.

Trade Name [App. No.]:

Xience and Promus Everolimus Eluting Coronary Stent System [P070015/S065]

Applicant/Date Approved:

Abbott Vascular, Temecula, CA; 4/29/11

Description:

Extension of shelf life and retest date of an intermediate component.

ACO Program . . . continued from page

5

ATA Wants Fewer Telehealth Restrictions In April 25 comments to CMS, the American Telemedicine Association writes that the agency does not go as far as the health reform law intended in promoting the use of telehealth and remote patient monitoring in the accountable care organization program. (See “ACOs Could Drive Growth In Digital Health Sector, Tech Firms Predict” – “The Gray Sheet” Jan. 24, 2011.)

ATA calls for CMS to waive “arbitrary barriers” to the use of telemedicine in ACOs by permitting, for example, the use of video conferencing in metropolitan areas to help in timely diagnosis of ischemic stroke.

“Stroke care is a good example of an urban health shortage alleviated by telemedicine,” ATA argues, noting that it is critical for patients to receive an ischemic stroke diagnosis within three or four hours of symptom onset in order to start clot-busting drug treatment.

Unauthorized photocopying is prohibited by law.

Provider Groups Suggest Changes In comments due to CMS June 6, groups representing hospitals, physicians and other providers recommend that the agemcy: • Offer alternate start dates for ACO participation in 2012 beyond Jan. 1, such as July 1 • Issue an interim final (rather than final) rule so that improvements can be readily made • Find new ways to encourage ACO participation by smaller groups or in rural areas • Reconsider the prior-approval requirement on all provider communications with Medicare beneficiaries related to ACO functions • Rethink health information technology meaningful use requirements • Allow individual ACOs to tailor their set of quality measures used in their programs

June 13, 2011 | 45

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®

N ews I n B rief Roper snaps up Northern Digital

Diversified health care, energy and industrial product provider Roper Industries acquires Canadian imaging device maker Northern Digital Inc. from investor group Audax for $204 million on June 6. Northern Digital’s optical and electromagnetic technology is used for image-guided surgical, industrial test and measurement, and research applications.

Merge Healthcare buys OIS

Health IT provider Merge Healthcare will acquire ophthalmic digital imaging and informatics systems maker Ophthalmic Imaging Systems for $30.3 million in stock under a definitive agreement announced June 6. The deal will add ophthalmic imaging and informatics to Merge Healthcare’s current portfolio of imaging solutions for radiology, cardiology and orthopaedics, according to the company. Under the terms of the agreement, Merge Healthcare will exchange about $1 of its stock for each share of OIS – representing a roughly 17% premium over the latter firm’s June 3 stock price close of $0.85. Merge Healthcare expects the deal to close

by Sept. 30.

Brainlab acquires Voyant Health

Image-guided surgical navigation system maker Brainlab will gain Voyant Health’s flagship TraumaCad orthopedic surgical planning system by acquiring the company for undisclosed terms, under a definitive agreement announced June 6.

Israeli firm Voyant’s technologies also include VoyantLink, which provides hospitals and care providers with easier access to diagnostic images from their referral network, and OrthoWeb, a web-based image uploading tool that integrates well with Munich-based Brainlab’s Quentry online network, the company explains. “By combining the capabilities of VoyantLink, OrthoWeb 46 | June 13, 2011

and Quentry, not only will we make diagnostic images available anytime and anywhere, but enriching, sharing and using that data for surgical treatment will be easier than ever,” Brainlab CEO Stefan Vilsmeier said.

Covidien looking to unload drug unit?

Diversified device maker Covidien is reportedly looking to divest its pharmaceuticals business to become a pure-play medical device and supply company, according to a June 8 Bloomberg report citing unnamed sources. Such a sale would likely boost revenue growth and operating margins, though it would reduce earnings-per-share, analysts say. The drug unit, which accounted for 19% of Covidien’s revenue in fiscal 2010 (ended Sept. 24), had sales of about $2 billion for the year, down 5%. Meanwhile, the firm’s medical devices and medical supplies segments posted sales of $6.72 billion (up 11%) and $1.72 billion (down 2%), respectively. While Covidien is not commenting on the divestiture rumors, cash generated from such a sale could be used for device acquisitions, debt repayment and/or stock repurchases, analysts speculate.

“Selling the pharma business would make sense for Covidien, in our view,” notes J.P. Morgan analyst Michael Weinstein in a June 8 report.

CARE Act

Bipartisan bill (H.R. 2104) requiring training and certification of certain health care personnel who conduct medical imaging and radiation therapy procedures is introduced in the House June 2 by Reps. Ed Whitfield, R-Ky., John Barrow, D-Ga., and 18 co-sponsors. The CARE Act would require all individuals who perform or plan imaging exams or radiation therapy, minus physicians, nurse practitioners and physician assistants, to undergo appropriate education and competency assessment through certification,

Whitfield said. The proposed measure, which has no counterpart in the Senate, is supported by the American Society of Radiation Oncology and Medical Imaging & Technology Alliance. It has been referred to the House Energy and Commerce and House Ways and Means Committees.

Pioneer ACO program deadlines pushed back

The Center for Medicare and Medicaid Innovation within CMS has extended two deadlines related to its “Pioneer ACO” model for accountable care organizations.

Letters of intent to file an application under the program are due June 30, and applications must be postmarked

by Aug. 19, instead of the original deadline of July 18. (See “CMS Seeks To Jumpstart Accountable Care Organization Program” – “The Gray Sheet” May 23, 2011.)

Given Imaging’s PillCam Colon 2

Capsule endoscopy firm begins 800-patient pivotal trial of its PillCam Colon 2 digestible video imaging capsule to support a planned 510(k) submission for use as an alternative to standard colonoscopy. The double-blind clinical trial will enroll patients aged 50-75 years who are at average risk for colonic polyps at 11 sites in the U.S. and six sites in Israel.

Comparing capsule endoscopy to optical colonoscopy, the primary endpoint will be the identification of patients with polyps greater than or equal to six millimeters in size. Given Imaging says the wireless camera device will benefit the approximately 50% of Americans who should be screened for colon cancer but who are unwilling or unable to undergo standard colonoscopy. The device, which gained a European CE mark in 2009, incorporates next-generation PillCam platform technology.

Current Given offerings also include PillCam systems for imaging the esophagus and small bowel. © 2011 F-D-C Reports, Inc., an Elsevier company. All rights reserved.