HospiMedica International June 2016 by Globetech

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Vol.34 No.3 • 5-6/2016

L E A D E R DAILY CLINICAL NEWS

ISSN 0898-7270

Proton Radiotherapy Bests Standard Radiotherapy roton beam therapy (PBT) to treat medulloblastoma in pediatric patients appears to be as safe as conventional treatment and offers similar survival rates, according to a new study. Researchers at Massachusetts General Hospital (MGH; Boston, MA, USA; www.massgeneral.org) and Brigham and Women’s Hospital (Boston, MA,

Medical Device Manufacturers Required To Incorporate Cybersecurity Features he US Food and Drug Administration (FDA; Silver Spring, MD, T USA; www.fda.gov) has issued a draft guidance outlining important steps medical device manufacturers should take to address cybersecurity risks. According to the FDA, cybersecurity threats to medical devices are a growing concern, and exploitation of

cybersecurity vulnerabilities presents a potential risk to the safety and effectiveness of such devices. While manufacturers can incorporate controls in the design of a product to help prevent these risks, they must also consider improvements during maintenance of devices, since the evolving nature of cyber threats means risks

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Hybrid PET/MRI Enhances Breast Cancer Imaging

Fusion Biopsy Detects Malignant Prostate Cancers ew MRI technologies, such as fusion biopsy, are helping urologists locate malignant prostate cancer lesions more accurately. Fusion biopsy enables physicians to perform biopsies with the help of direct guidance of the needle, using real-time ultrasound imaging, to the suspicious lesion. The patient first undergoes a Magnetic Resonance Imaging (MRI) exam of the prostate gland. The images are then evaluated by a

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Skin Regeneration System Treats Diabetic Foot Ulcers n advanced skin replacement matrix encourages new skin and tissue to regenerate and heal diabetic foot ulcers (DFUs) and third-degree burns. The Integra LifeSciences (Plainsboro Township, NJ, USA; www. integralife.com) Omnigraft Dermal Regeneration Template – previously known as the Integra Dermal Regeneration Template (IDRT) – is a complex three-dimensional (3D) porous collagen matrix made of silicone,

n innovative imaging technique named Digital Hybrid Breast PET/MRI for Enhanced Diagnosis of Breast Cancer (HYPMED) can improve breast cancer detection and characterization as well as help clinicians better evaluate a patient’s response to treatment.

A Image: Courtesy of Philips Healthcare

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new portable three dimensional (3D) ultrasound instrument helps reduce catheter-associated urinary tract infections (CAUTI) by reducing the use of catheters.

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Touchless Vital Signs Monitor Offers Earlier Detection of Heart Problems

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Portable 3D Ultrasound Quantifies Bladder Volume

novel system based on transmittance photoplethysmographic imaging (PPGI) can be used as an alternative for measuring blood pulse signals at a distance. Developed by researchers at the University of Waterloo (Canada; https://uwaterloo.ca), the patentpending device monitors a patient’s

blood flow at multiple arterial points simultaneously, without direct contact with the skin, using a technology called coded hemodynamic imaging; temporally coded illumination (TCI) is used for ambient light correction. The device relays the measurements from all of the pulse points to a signal processing Cont’d on page 5

News Update . . . . . . . . . . . . 14 Product News . . . . . . . . 14-18

News Update . . . . . . . . . . . . 20 Product News . . . . . . . . .20-26

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HospiMedica International

Fusion Biopsy Detects Malignant Prostate Cancers cont’d from cover

radiologist for suspected lesions. Next, a device called UroNav, made by Invivo (Gainesville, FL, USA; www.invivocorp.com), uses the information from the MRI exam, and live ultrasound imaging to enable urologists to more accurately perform the prostate biopsy procedure. The procedure is especially effective for men who have undergone a traditional biopsy without cancer being found, despite PSA blood tests indicating a risk for prostate cancer. In the US, approximately 1.2 million men undergo a biopsy each year, and around 20 million Prostate-Specific Antigen (PSA) tests are performed. Trans-Rectal UltraSound (TRUS) biopsy and other traditional techniques on-

ly sample the lower part of the prostate gland, while nearly 30% of cancers are outside this area. The result has been that traditional biopsy methods have led to only 30%–40% results positive for prostate cancer, out of 1.2 million biopsies performed each year. The fusion-guided prostate biopsy is especially useful for monitoring any change in the clinical status of low-risk patients, and can also help find more aggressive cancers faster, preventing metastasis. Dr. David Samadi, David Samadi Prostate Cancer Center (New York, USA), said, “The MRI guided fusion biopsy allows for more accuracy, less repeat biopsies, and less pain. It is expected to eventually become standard of practice.”

Portable Ultrasound Device Quantifies Bladder Volume cont’d from cover

The Verathon BladderScan Prime is a noninvasive bladder volume measurement tool that acquires multiple scan planes inside the body, produces 3D quantification of the bladder, and then automatically calculates and displays urinary bladder volume. To boost reading accuracy among users of varying skill levels, the device provides simple and advanced aiming modes; immediate feedback for off-center scans and pubic bone interference; and onboard help and tutorial assistance accessible at any point during the exam. Features of the system include a touchscreen interface, live B-mode scanning, and onboard self-diagnostics; for example, in the event of a drop, the ultrasound probe has an internal mechanical diagnostic to confirm it is still functioning properly. Benefits of the system include reducing unnecessary catheterizations; management of Foley catheter use and incontinence issues; and reducing costs and nursing staff time. The Verathon BladderScan Prime is a product of Verathon (Bothell, WA, USA; www.verathon.com). “Prime is built to be a workhorse device in any healthcare environment. It is designed to reduce downtime, which in turn raises quality of care,” said David Garner, global director of marketing for imaging & scanning solutions at Verathon. Bladder volume measurement is a wellestablished metric used in the diagnosis and treatment of a wide range of medical conditions. It is a critical component of a comprehensive catheter-associated urinary tract infections (CAUTI) prevention program, an area of intense focus for hospitals as a result of Medicare penalties for hospitals with high rates. These include reducing payments by one percent for hospitals with a high number of hospital-acquired conditions (HACs).

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Image: The UroNav fusion biopsy system fuses pre-biopsy MR images of the prostate with ultrasound-guided biopsy images in real time, for enhanced delineation of the prostate and suspicious lesions, as well as clear visualization of the biopsy needle (Photo courtesy of Invivo).

HospiMedica International

New Hybrid PET/MRI System Offers Enhanced Breast Cancer Imaging novel imaging technique is being developed that can improve breast cancer detection and characterization, and help clinicians evaluate the response of the cancer to treatment. The 4-year project, named Digital Hybrid Breast PET/MRI for Enhanced Diagnosis of Breast Cancer (HYPMED), began on January 1, 2016, and is being developed under a new cross-European project coordinated by the European Institute for Biomedical Imaging Research (EIBIR; Vienna, Austria; www.eibir.org). Other HYPMED project partners include the University Hospital Aachen (UKA; Aachen, Germany; www.ukaachen.de/en), and four other research institutes in Germany and The Netherlands. Four industry partners in Germany, France, and The Netherlands, including Royal Philips (Amsterdam, The Netherlands; www.philips.com) are also taking part. Breast cancer is still the most common female cancer, and a major cause of cancer death in women. The stage at which breast cancer is detected is at the moment the most important factor indicating survival of the patient, and there is a pressing need to improve early diagnosis of the disease.

The HYPMED project will develop a hybrid Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET) imaging system intended to improve diagnosis of breast cancer, and provide personalized control of therapy results. The consortium intends to develop a Radio Frequency (RF) coil that can used in any standard clinical MR scanner, transforming the scanner into a high-resolution hybrid PET/MRI system that can identify extremely small breast cancer foci, better characterize the cancer, and improve treatment response. The radiation dose of the new system is expected to be minimal, comparable to a regular digital mammogram. The consortium also plans to use the HYPMED approach in the future for prostate cancer detection, hybrid cardiac imaging, and other diseases. Scientific Coordinator of the project, Professor Christiane Kuhl, University Hospital Aachen, said, “The HYPMED project combines visionary clinical expertise with excellence in physical and engineering sciences and the developed technology will greatly help us to choose an appropriate treatment that is exactly right for a given cancer in a given woman.”

Study Reveals Determining Factors for Frequent Emergency Department Visits new study in the USA reveals distinct patterns of emergency department (ED) usage and patient diagnoses between frequent and infrequent patient encounters, suggesting ways to improve care and streamline ED workflow. Researchers at the Rensselaer Polytechnic Institute (RPI; Troy, NY, USA; www.rpi.edu) analyzed US Medicare and Medicaid Services (CMS; Baltimore, MD, USA; www.cms.gov) patient data from 1,149,738 electronic health records (EHRs) to try and understand the characteristics of ED return visits within a 72-hour time frame. The analysis revealed that frequent flyer (FF) patients with multiple revisits account for 47% of Medicaid patient revisits over the time period, and that ED encounters by FF patients with prior 72-hour revisits in the previous six months are thrice more likely to result in a readmit than those of infrequent patients. From an initial dataset containing over 15,000 potential factors, including primary and secondary treatment codes, demographics, treatment dates and times, and discharge status, the researchers mapped 385 discrete and continuous features using domain knowledge and statistical analyses. The researchers then conducted an analysis to delineate

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the differences between infrequent and FF revisit patients. The results revealed only three relevant features: alcoholism, living within zip codes with high revisit rates in close proximity to the hospital, and frequent use of the ED and hospital in the past six months. For the cohort with no prior visits, the models were more complex, involving a combination of diagnosis codes, patient history, and features of the visit such as time, costs, and discharge status. According to the researchers, the marked difference in model features for the two cohorts suggests that distinct opportunities exist among these two patient populations for associated interventions to simultaneously boost the efficacy of care while streamlining ED work flow. The study was published on January 11, 2016, in Big Data. “Our study demonstrated that there are distinct differences in the determinants for ED revisits among frequent patients and other patients,” concluded lead author James Ryan, PhD, and colleagues. “Further work in the ED revisits should consider the differences in behavior, utilization, and affliction among these groups while exploring how different definitions of readmission events alter the analytic space and the potency of constructed models.” “This paper shows the impact resulting from the intelligent use of big data for reducing readmissions to emergency departments,” said Prof. Vasant Dhar, PhD, of New York University, editor-in-chief of Big Data. “The authors identify the factors associated with high risk of readmission such as psychiatric and substance abuse and combine them into a model that results in actionable models for decision makers. This type of research will be very useful to healthcare providers as they attempt to align themselves with the requirements of the Affordable Care Act.”

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ISSN 0898-7270 Vol.34 No.3 • Published, under license, by Globetech Media LLC Copyright © 2016. All rights reserved. Reproduction in any form is forbidden without express permission. Teknopress Yayıncılık ve Ticaret Ltd. S¸ti. adına ˙Imtiyaz Sahibi: M. Geren • Yazı is¸leri Müdürü: Ersin Köklü Müs¸ ir Dervis¸ ˙Ibrahim Sok. 5/4, Esentepe, 34394 S ¸ is¸ li, ˙Istanbul P. K. 1, AVPIM, 34001 ˙Istanbul • E-mail: Teknopress@yahoo.com Baskı: Promat Web Ofset Tesisi • Orhangazi Mahallesi 1673. Sokak, No: 34 • 34510 Esenyurt, B. Çekmece • ˙Istanbul Yerel süreli yayındır. Yılda sekiz kere yayınlanır, ücretsiz dag˘ıtılır.

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Touchless Vital Signs Monitor Offers Earlier Detection of Heart Problems cont’d from cover

pipeline for PPGI signal extraction, thus allowing for continuous monitoring. Experimental results have shown that the processing steps yield a substantially more pulsatile PPGI signal than the raw acquired signal, resulting in statistically significant increases in correlation for both short- and long-distance monitoring. According to the researchers, long-distance heart rate monitoring using the device is ideal for assessing patients with painful burns, highly contagious diseases, or infants in neonatal intensive care units (nICUs), whose miniscule fingers make traditional monitoring difficult. The study was published on October 6, 2015, in Nature Scientific Reports. “Since the device can also scan multiple patients individually at once and from a distance, consider

the potential in mass emergency scenarios or long-term care homes,” said senior author Prof. Alexander Wong, PhD, of the faculty of engineering. “This technology provides for a more predictive approach to monitor vitals and the potential for its use is extensive, such as indicating arterial blockages that might otherwise go undetected, or warning older adults who risk falling as a result of getting dizzy when they stand.” PPG was invented in the 1930’s to detect changes in light intensity, serving as a proxy measure for changes in blood volume in a particular area of the body. Until now, PPG has only been effective when it was used in close proximity with the patient’s body, but the new device is equipped with

sensors that are able detect hemodynamic waveforms from a distance. Image: Prof. Alexander Wong and Robert Amelard analyze blood-flow data extracted with the new touchless device (Photo courtesy of Fred Hunsberge / Waterloo University).

Proton Radiotherapy Bests Standard Radiotherapy cont’d from cover

USA; www.brighamandwomens.org) conducted a non-randomized, open-label, phase 2 trial involving 59 patients (aged 3–21 years) with medulloblastoma to assess late complications, acute side effects, and survival associated with PBT. All patients underwent craniospinal irradiation of 18–36 Gy radiobiological equivalents (GyRBE), followed by a boost dose. The primary outcome was cumulative incidence of ototoxicity at three years; secondary outcomes were neuroendocrine toxic effects and neurocognitive toxic effects, as assessed by intention-to-treat. The results showed that three years after treatment, progression-free survival was at 83%, and at five years, progression-free survival was 80%; 12% of patients had serious hearing loss, which rose to 16% at five years. Processing speed and verbal comprehension were also affected, but perceptual reasoning and working memory were not. At five years, 55% had problems with the neuroendocrine system, with growth hormone being the most commonly affected. On the other hand, the researchers found no cardiac, pulmonary, or gastrointestinal toxic effects, which are common in patients treated with photon radiotherapy. The study was published on January 29, 2016, in the Lancet Oncology. “Proton radiotherapy resulted in acceptable toxicity and had similar survival outcomes to those noted with conventional radiotherapy, suggesting that the use of the treatment may be an alternative to photon-based treatments,” concluded lead author Torunn Yock, MD, and colleagues of the MGH Proton Center. PBT is a precise form of radiotherapy that uses charged particles instead of X-rays to deliver a dose of radiotherapy more precisely and with minimal damage to surrounding tissue. Evidence is growing that protons can be effective in treating a number of cancers, in particular children and young people with brain tumors, for whom PBT appears to produce fewer side effects such as secondary cancers, growth deformity, hearing loss, and learning difficulties.

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ANESTHESIA WORKSTATION

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The Atmos C / E 341 battery device is used for suction from the oral cavity, nasopharyngeal cavity, and bronchial system. The mobile device is ideal for hospitals and nursing homes during emergencies where there is danger to life due to a blocked respiratory tract.

The Dräger Fabius plus XL features an electronically driven piston ventilator and allows the addition of extra monitors, gas cylinders, and other accessories like infusion pumps. It comes with mounting rails for the additional equipment, and displays information on a 10.5-inch color display.

The ivNow heats and maintains safe temperatures of intravenous and irrigation fluids, and can automatically warm fluids up to 104°F (40°C) in 30 minutes or less. It is ideal for in patient rooms, surgery centers, dialysis/nephrology, and labor and delivery units.

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Fluid Monitor Aids Clinical Assessment of Lymphedema novel monitoring system utilizes bioimpedance spectroscopy (BIS) to accurately measure tissue composition and fluid status. The L-Dex U400 is designed to aid in the evaluation of unilateral lymphedema in arms by measuring certain characteristics of electrical resistance in the extracellular fluid present in a patient’s limb. The results are delivered on a numeric scale, providing an instant and accurate tool for clinical assessment of lymphedema progression, as well as a way to track changes in the patient over time. The technology, which is specific for extracellular fluid, is unaffected by changes in the patient’s weight due to changes in fat mass or muscle mass, and can detect lymphedema up to 10 months before there is evidence of limb swelling. The device can store more than 1,000 data records, which can be analyzed directly on the device or downloaded via an Ethernet connection to proprietary unilateral lymphedema analysis software installed on a Windows PC. To perform a measurement, three color-coded leads and dual-tab elec-

trodes are placed on the patient, with measurements carried out by following on-screen instructions. Results appear on-screen and can be uploaded for storage or additional analysis. The L-Dex U400 is a product of ImpediMed (Brisbane, Australia; www.impedimed.com), and has been approved by the US Food and Drug Administration (FDA). “Fluid monitoring is a critical component in the continuum of care for cancer survivors. L-Dex is an accurate measurement tool, which can help improve health outcomes for patients through earlier identification of lymphedema,” said Richard Carreon, managing director and CEO of ImpediMed. “Our objective is to not only make L-Dex the standard of care in the clinical assessment of early stage lymphedema, but to explore its potential in other areas where a simple, sophisticated platform could accurately measure and monitor fluid levels, leading to better patient outcomes.”

Lymphedema is an accumulation of fluid in tissues that is commonly caused by abnormalities in the lymphatic system or due to removal or damage to a person’s lymph nodes. Symptoms include swelling, recurrent cellulitis, loss of physical function, psychological stress, and a diminished qualify of life. It cannot be cured, and is typically managed through combined therapies of manual lymph drainage, multilayer bandaging, decongestive exercise, skin care, and long-term self-management. Image: The L-Dex U400 system for measuring tissue composition and fluid status (Photo courtesy of ImpediMed).

Neonates’ Pain Should Preferably Be Managed Without Drugs ealth care professionals who work with newborns should aim to limit painful procedures and manage mild pain without medication when possible, according to an updated policy statement issued by the American Academy of Pediatrics (AAP; New York, NY, USA; www.aap.org). According to the statement, pain that is not well managed can have short- and long-term effects on the neurodevelopment, behavior, and cognitive function of children. The AAP therefore recommends that for mild to moderate pain, practitioners should look for non-pharmacologic interventions, such as those backed by additional research as detailed in the updated policy. The recommended approaches include skin-to-skin contact, facilitated tucking, sensorial stimulation, swaddling, non-nu-

tritive sucking, and massage. The next level of care would be oral sucrose and/or glucose, which should be tracked as medications. For those whose pain cannot be managed with these approaches, doctors should weigh the risks and benefits of pharmacologic interventions with opioids, benzodiazepines, and other drugs. For some procedures, such as circumcision, chest drain insertion and removal, and nonemergency intubations, the AAP recommends routine pain management. However, more research is needed as to the best way to manage pain during other procedures like mechanical ventilation. Additional recommendations include creating a pain prevention and treatment plan that includes judicious use of approved procedures and routine pain assessment; using validated neonatal pain as-

sessment tools before, during, and after painful procedures; and that healthcare providers and family members should receive continuing education on assessment and management of pain. The AAP policy statement, called “Prevention and Management of Procedural Pain in the Neonate,” was published in the February 2016 issue of Pediatrics. “There’s emerging evidence that parents particularly can be very effective in helping the nurse at the bedside to contain the baby, or provide the pacifier the sucrose is on, or perform skin-to-skin care or breastfeeding during the procedure, so really integration of the parent into the whole plan of care can be really effective,” said lead co-author Erin Keels, APRN, the National Association of Neonatal Nurses (Chicago, IL, USA; www.nann.org) liaison to the AAP Committee on Fetus and Newborn (COFN). HospiMedica International May-June/2016

Minimally Invasive System Helps Modulate Blood Pressure novel implant mechanically amplifies signals received by arterial baroreceptors, leveraging the body’s natural tendency to lower resistant hypertension by vasodilation. The MobiusHD is a passive implant designed to reshape the carotid sinus in the diastolic phase and prevent vessel migration in the systolic phase; the reshaping of the vessel results in an increased radius with every pulsatile wave, which is concentrated within the windows of the implant. As the radius of the vessel is directly proportional to strain in the sinus wall, the baroreceptors perceive it as an increase in pulsatile blood pressure and increase afferent signaling to the medulla, resulting in a commensurate reduction in blood pressure. The nitinol implant is available in three different sizes for vessels with diameters ranging from 5.0 to 11.75 mm. Delivery is via percutaneous coronary intervention (PCI) to the carotid bulb, where the carotid arterial baroreceptors are concentrated. The MobiusHD is a product of Vascular Dynamics (Mountain View, CA, USA; www.vasculardynamics. com) and has received the European Community (CE) marking of approval. The company is conducting a prospective multicenter study in the US and Europe with the primary endpoint being safety at six months post-procedure. “Receiving CE Mark approval for the treatment of resistant hypertension is a major milestone for our

company as we validate our novel solution for the millions of people whose hypertension is not adequately controlled by drugs,” said Robert Stern, President and CEO of Vascular Dynamics. “Initial results suggest significant improvement in the average blood pressure readings post barostenting procedure.” “I’ve seen numerous approaches to controlling resistant hypertension over the years. Most drugs have side effects leading to poor compliance, and more invasive approaches have other drawbacks,” said Gregg Stone, MD, director of cardiovascular research and education at Columbia University Medical Center (CUMC; New York, NY, USA; www. cumc.columbia.edu). “The minimally invasive MobiusHD barostenting procedure could be life changing for this patient population, while also reducing the cost of healthcare.” Baroreceptors are stretch-sensitive fibers located in the aortic arch and the carotid artery sinus. Their activation triggers an afferent nerve negative-feedback signal to the medulla that helps maintain normal arterial pressure. When working normally, baroreceptors buffer blood pressure fluctuations by causing reflex-mediated reciprocal changes in heart rate and sympathetic nerve activity, thus keeping arterial pressure at a predetermined operating level. However, in patients with chronic hypertension, the elevations in pressure threshold can result in decreased baroreceptor activity.

Image: The MobiusHD passive implant for blood pressure control (Photo courtesy of Vascular Dynamics).

New Oral Medication Reverses Anticoagulant Effects new study shows that the antibody Idarucizumab can chemically bind to and neutralize the blood-thinning effects of dabigatran. Researchers at Northwestern Memorial Hospital (NMH; Chicago, IL, USA; www.nm.org), University Hospital Leuven (UZ Leuven; Belgium; www.uzleuven.be), and other institutions participating in the Reversal Effects of idarucizumab in patients on Active Dabigatran (RE-VERSE AD) study reported the results of an interim analysis, showing that idarucizumab effectively reversed dabigatran’s anticoagulant effects in brain hemorrhage patients. The new results are part of the large on-going phase III study that is testing idarucizumab in a range of patients on dabigatran and who have dangerous bleeding or need urgent surgery or other procedures that carry serious bleeding risks. Before idarucizumab was available, these patients, when in need of emergency surgery, were given purified clotting factors, which could induce dangerous blood clot formation. The study was presented at the American Stroke Association International Stroke Conference, held during February 2016 in Los Angeles (CA, USA).

HospiMedica International May-June/2016

“This is definitely good news. Idarucizumab rapidly and completely reverses the effect of dabigatran in patients with brain hemorrhage. Once the dabigatran is reversed, we can focus on taking care of the patient without worrying about the blood thinner,” said lead author and study presenter Richard Bernstein, MD, PhD, director of the stroke program at NMH. “Idarucizumab gets rid of the dabigatran, but doesn’t seem to carry with it any tendency to increase clotting. This should make perioperative management easier and safer.” Dabigatran is a novel oral anticoagulant (NOAC) that works by directly inhibiting thrombin; it was developed by the Boehringer Ingelheim (Germany; www.boehringer-ingelheim.com) and is marketed as Pradaxa. Until the introduction of NOACs, warfarin had been one of the only treatment options for long-term anticoagulation of patients with conditions that require chronic anticoagulation. The major benefit of the NOAC anticoagulants is that they do not require strict and frequent laboratory monitoring, dosing adjustments, or dietary restrictions, and incur fewer drug interactions than warfarin. LINKXPRESS COM

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HOSPITAL EQUIPMENT

PORTABLE VENTILATOR

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MAC Medical

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The Elisa 800 VIT is a fully integrated EIT system in an intensive care ventilator. Its non-invasive pulmonary monitoring visualizes ventilation-related complications, and allows for direct therapy at the intensive care ventilator.

The PTF2000-EYE features a retractable center fifth wheel for straight-line mobility, effortless pivoting and cornering. It features dual fowler-assisted lift backrest with 90-degree adjustability and a dual articulating head attachment for optimal head clearance and surgeon access.

The Eagle II offers AC mode, as well as SIMV and CPAP (NPPV/PPV) modes with pressure support. Weighing less than 10 pounds, it can be mounted on the wall or on a roll stand or bed, and has a 10hour battery run-time with rapid recharge in two hours.

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Microfiber Pad Helps Collect Uncontaminated Urine Samples new noninvasive microfiber pad draws urine samples in seconds, preventing cross-contamination during collection. Developed by researchers of the BioDesign team at the Hebrew University (HUJI; Jerusalem, Israel; www.huji.ac.il) and Hadassah Medical Center (Jerusalem, Israel; www.hadassah-med.com), the UCap microfiber urine collection pad contains bundles of hollow glass microfibers that quickly draw urine via capillary action from absorptive pads in just seconds. The remainder of the urine is absorbed by a polymer matrix, thus preventing crosscontamination of the urine sample by contact with the patient’s skin or fecal matter. The low-cost but highly effective solution can save time and money in the collection of sterile samples from patients especially prone to contract a urinary tract infection (UTI), including infants and

bed-ridden hospitalized patients. While sterile urine samples can be readily collected in adults using simple plastic cups, urine collections in infants and hospitalized populations rely on adhesive plastic bags or on invasive catheters. “Contamination of urine samples from infants and the elderly is so common that physicians often needlessly prescribe broad-spectrum antibiotics prophylactically, increasing the risk of developing antibiotic resistant bacteria,” said Amir Orlev, MD, who was part of the multidisciplinary BioDesign team set out to solve the problem under a medical innovation program. “More than 11 million urine tests are carried out each year in infants and elderly patients. This presents a market of USD 100 million annually in the United States alone,” said BioDesign team member MBA student Itai Monnickendam. “Our low-cost

urine collection pad has the potential to reduce pain and complications for millions of people and save time and expenditure for the healthcare system.” Image: The UCap microfiber urine collection pad (Photo courtesy of BioDesign/HUJI).

Laryngeal Mask Reduces Life-Threatening Complications disposable laryngeal mask helps make airway management easier by keeping gastric contents away from the airway in the unlikely event of regurgitation. The LMA Protector Airway is a single-use laryngeal mask with a dual gastric drainage channel and a pharyngeal chamber that provides easy access for evacuation of gastric content escaping through the upper esophageal sphincter. The elongated, 100% silicone cuff and airway tube design conforms to the contours of the hypopharynx, with proprietary First Seal and Second Seal technology used to secure the distal tip at the upper esophageal sphincter, thus isolating the respiratory tract from the digestive tract and reducing the risk of

aspiration of gastric contents. Another advanced airway management innovation of the device is Cuff Pilot, a pressure indicator that enables clinicians to confirm that the inserted cuff is properly inflated and to monitor pressure levels continuously, thus reducing the risk of patient trauma or leaks. The LMA Protector is designed for insertion without the need for any guidance tools, and allows for subsequent intubation with an endotracheal tube (ETT) of up to 7.5 mm in diameter that can provide a safe and effective option for airway replacement. Potential uses include difficult cases where an ETT may otherwise be used for patients with gastroesophageal reflux disease (GERD), cases in which

positive pressure ventilation (PPV) may be required, to reduce the likelihood of throat irritation and stimulation, and as an option for clinicians who want continuous cuff pressure monitoring to reduce the likelihood of over inflation. The LMA Protector Airway, a product of Teleflex (Limerick, PA, USA; www.teleflex.com), and has been approved by the US food and Drug Administration (FDA). A laryngeal mask is designed to keep the airway open during anesthesia or unconsciousness. It is composed of an airway tube that connects to an elliptical mask with a cuff, which is inserted down the windpipe, and once deployed forms an airtight seal on top the glottis, unlike ETTs, which pass through it.

Image: The LMA Protector Airway (Photo courtesy of Teleflex). HospiMedica International May-June/2016

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PRODUCT NEWS ANESTHESIA SYSTEM

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CARDIOLOGY DEFIBRILLATOR

BLOOD PRESSURE MONITOR

Fritz Stephan GmbH Medizintechnik

Nihon Kohden

Rudolf Riester

The Akzent features a high contrast color display, tidal volumes from 5-1500 ml, and a ventilation frequency from 3-100 minutes. An integrated, heated breathing system also helps provide professional care for neonatal, pediatric, and adult patients.

The Cardiolife AED-3100 starts the automatic charging process immediately upon detecting a heart rhythm, and indicates when to press the shock button. It features voice output, which guides the user through the resuscitation procedure.

The ri-medic BP monitor independently validates BP to BHS, ESH and AAMI SP10 specifications. Featuring a manual SphygMode with auto-deflate for consistent patient BP measurement, it offers readings in 30-40 seconds, and comes with a full range of blood pressure cuff sizes.

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Anal Sphincter Augmentation Helps Treat Fecal Incontinence new magnetic system helps treat fecal incontinence in patients who are not candidates for, or have previously failed, medical or other surgical options. The main component of the Fenix Fecal Incontinence system is an implant that is constructed of a series of titanium beads with magnetic cores, which are connected by titanium wires to form a ring shape. The attractive force of the magnetic beads augments the function of the anal sphincter, thus minimizing involuntary opening of the anal canal and reducing the likelihood of severe fecal incontinence. The magnetic titanium bead system implant is placed around the anal sphincter during a surgical procedure that requires a single incision. A proprietary sizing tool is used to associate the anal sphincter size to an appropriate implant, and a special introducer tool is used to guide both the sizing tool and the implant into position. Once the correct position has been confirmed using fluoroscopy, the Fenix system is implanted and secured by suturing. The correct size is reconfirmed once again using fluoroscopy before closure, and no post

implant adjustments are required. Once in position it is immediately effective. The system should not be implanted in patients with suspected or known allergies to titanium, and is considered unsafe for magnetic resonance imaging (MRI), as the magnetic forces could interfere with the strength and the function of the device. The Fenix Fecal Incontinence system is a product of Torax Medical (St. Paul, MN, USA; www. toraxmedical.com), and is offered in multiple sizes to accommodate variation in sphincter size. The device is similar to another Torax Medical device, the Reflux Management System. “Noninvasive treatment options for fecal incontinence, such as drugs, dietary changes and other medical measures, sometimes don’t adequately address a patient’s symptoms,” said William Maisel, MD, acting director of the office of device evaluation at the US Food and Drug Administration (FDA). “The Fenix System affords a viable surgical option to address this condition when other methods have failed to improve a patient’s quality of life. The device was approved using the humanitarian

device exemption pathway for devices that treat rare diseases or conditions.” Fecal Incontinence is the inability to control bowel movements, causing stool to leak unexpectedly from the rectum. The leakage can range from an occasional small quantity of stool to a complete loss of bowel control. Fecal incontinence can have several causes, including constipation, damage to anal sphincter muscles and nerves, damage to the muscles or the rectum, loss of storage capacity in the rectum, diarrhea, and pelvic floor dysfunction. Image: The Fenix Fecal Incontinence device implanted around anal canal (Photo courtesy of Torax medical).

Many IBS Patients Suffer from Vitamin D Deficiency he irritable bowel syndrome (IBS) population exhibits significant levels of vitamin D insufficiency and would benefit from screening, suggests a new pilot study. Researchers at the University of Sheffield (United Kingdom; www.sheffield.ac.uk) and Cultech (Port Talbot, United Kingdom; www.cultech.co.uk) conducted a randomized, double blinded, threearm parallel design study of vitamin D, placebo, or a combination of vitamin D and probiotics in 51 IBS patients. Study participants were further stratified according to whether they were vitamin D replete or insufficient, as determined by a blood test at baseline and exit. IBS symptoms were assessed by validated questionnaire, and dietary intakes were assessed by food frequency questionnaire.

The results showed that 82% of the IBS cohort in the study was vitamin D deficient, to such a degree that repletion levels could not be adequately recruited. The researchers also found a significant association in the baseline data between circulating vitamin D level and quality of life. Subsequent Vitamin D supplementation succeeded in significantly improving vitamin D level, although the IBS symptoms themselves were not significantly improved during the pilot study. The study was published on December 21, 2015, in BMJ Open Gastroenterology. “IBS is a poorly understood condition which impacts severely on the quality of life of sufferers. Our work has shown that most IBS sufferers in our trial had insufficient levels of vitamin D,” said lead author Bernard Corfe, PhD, of the University of

Sheffield molecular gastroenterology research group. “Furthermore there was an association between vitamin D status and the sufferer’s perceived quality of life, measured by the extent to which they reported impact on IBS on life.” IBS is a diagnosis of exclusion. It is a functional bowel disorder characterized by chronic abdominal pain, discomfort, bloating, and alteration of bowel habits in the absence of any detectable organic cause. In some cases, the symptoms are relieved by bowel movements. Diarrhea or constipation may predominate, or they may alternate (classified as IBS-D, IBS-C or IBS-A, respectively). IBS may begin after an infection (post-infectious, IBS-PI), a stressful life event, or onset of maturity without any other medical indicators. HospiMedica International May-June/2016

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Critical Care

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Single-Use Ureteroscope Does Away with Reprocessing new disposable digital urinary tract endoscope for stone removal eliminates the need for maintenance and sterilization. The LithoVue is single-use, digital flexible ureteroscope for minimally invasive endoscopic procedures that is designed to diagnose and treat stones and other conditions of the kidney, ureter, and bladder. By providing a single-use alternative to reusable devices, the LithoVue helps users overcome unpredictable scope repairs and maintenance, reprocessing, sterilization, and degradation of scope performance over time. The system includes a mobile workstation monitor with integrated image processing software, which can also be combined with other systems in the operating room (OR). Among the features of the system is a digital CMOS imager located in the 7.7F tip of the scope, with a working distance of 2–50 mm, which helps produce high-definition (HD) quality images across an extensive depth of field. The system also provides a full 270° scope deflection in both directions, providing accurate navigation toward the targeted treatment area. The LithoVue is a product of Boston Scientific Corporation (Natick, MA, USA; www. bostonscientific.com), and is available in the United States, Europe, and New Zealand. “At Boston Scientific, we are committed to providing innovative solutions to the healthcare chal-

lenges that our customers face every day,” said Karen Prange, senior VP of urology and pelvic health at Boston Scientific. “The LithoVue System is an example of how we are focused on addressing unmet needs by providing urologists and hospitals a predictable, cost-effective, minimally invasive endoscope for the management of kidney stones.” “Flexible ureteroscopy is considered the gold standard for treating many stones in the ureter and kidney, and the LithoVue System provides high-quality visualization that is comparable to or better than the leading digital reusable ureteroscopes,” said Professor of Urologic Surgery Glenn Preminger, MD, director of the Duke University (Durham, NC, USA; www.duke.edu) comprehensive kidney stone center. “We believe that the LithoVue System offers a safe, effective, and affordable solution that helps to avoid many of the hassles and unpredictable challenges of reusable ureteroscopes, without compromising visualization or maneuverability.” On average, digital flexible ureteroscopes require

repair after fewer than 12 uses, at a cost of more than USD 6,000 per repair. Procedural delays are also often due to reprocessing and repairs, resulting in a daily average cost of USD 830 per delay. Image: The LithoVue single-use, digital flexible ureteroscope (Photo courtesy of Boston Scientific).

Millimeter-Wave Radar Measures Heartbeats Remotely novel sensing system based on spread-spectrum radar technology can measure heartbeats remotely, in real time, and with as much accuracy as an electrocardiograph. Developed by researchers at Kyoto University (Japan; www.kyoto-u.ac.jp), and Panasonic (Osaka, Japan; www. panasonic.com), the remote sensing system combines radar technology with a heartbeat interval estimation algorithm that identifies diverse signals emanating from the body, isolate heartbeats from the composite radar signal, and calculate their intervals. According to the researchers, the technology could allow for the development of “casual sensing,” for instance by taking measurements as people go about their daily activities, such as going to bed or getting ready to start the day. Although most conventional systems use either continuous waves or impulse-radio systems for remote vital monitoring, continuous waves suffer from non-stationary clutters, while impulse-radio systems cannot detect heartbeats. The researchers therefore used an ultra-wideband radar system with a moderate fractional bandwidth, resulting in both the suppression of

clutters and high sensitivity in measuring accurate heart rates even in a dynamic environment. A study describing the concept was published in early 2015 in IEICE Electronics Express. “The body sends out all sorts of signals at once, including breathing and body movement; it’s a chaotic soup of information. Our algorithm differentiates all of that,” said lead author Prof. Toru Sato, PhD, of the communications and computer engineering departments at Kyoto University. “Now that we know that remote sensing is possible, we’ll need to make the measurement ability more robust so that the system can monitor subjects in various age ranges and in many different contexts.” “Taking measurements with sensors on the body can be stressful and troublesome, because you have to stop what you’re doing. What we tried to make was something that would offer people a way to monitor their body in a casual and relaxed environment,” added Hiroyuki Sakai, a researcher at the Advanced Technology Research Laboratories at Panasonic. “The added convenience of remote sensing will be an incentive for people to monitor their health status for their own benefit.” HospiMedica International May-June/2016

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Critical Care

Cooling Cap Helps Reduce Hair Loss During Chemotherapy novel cooling system helps reduce the frequency and severity of alopecia during chemotherapy in breast cancer patients. The DigniCap scalp cooling system is based on a tight-fitting silicone cooling cap placed directly on the head, and an outer neoprene cap that insulates and secures the silicone cap. The cooling cap itself is connected to a control unit that circulates a liquid coolant through the silicone cap, thus delivering consistent, controlled cooling to all areas of the scalp. Two built-in sensors continuously monitor scalp temperature, maintaining optimal cooling throughout the treatment. A third built-in safety sensor ensures the cooling temperature as measured on the scalp never drops below freezing point. As the temperature of the scalp is lowered, blood vessel vasoconstriction reduces delivery of chemotherapy to the scalp, as well as inducing reduced cellular drug uptake due to decreased intrafollicular metabolic rate. The combined action is thought to reduce the effect chemotherapy has on the cells, which may reduce hair loss. Key system features include quick-disconnect to accommodate bathroom breaks, an intuitive touch screen interface to simplify operation, and flash memory that makes it possible to save data from each scalp cooling treatment and facilitates software upgrades. The cooling cap itself is available in multiple

sizes to insure a personalized fit, and has a smooth inner surface to enable optimal contact between scalp and cap. The cap is shaped to leave the patients’ ears uncovered for comfort and ease of hearing. An additional benefit is that two independently controlled systems can be used for the simultaneous treatment of two patients. The DigniCap scalp cooling system is a product of Dignitana (Lund, Sweden; www.dignitana.com), and has been approved by the US Food and Drug Administration (FDA). “Working with the professionals at our clinical trial sites has given us a significant head start in learning how best to provide the DigniCap scalp cooling system here in the United States,” said Bill Cronin, COO of Dignitana. “Additionally, we are fortunate to have attracted a talented group of professionals with scalp cooling experience, ready to help our future infusion center clients offer this valuable therapy option to patients as efficiently and as smoothly as possible.” “We are pleased to see a product for breast cancer patients that can minimize chemotherapy-in-

duced hair loss and contribute to the quality of life of these individuals,” said William Maisel, MD, MPH, acting director of the office of device evaluation at the FDA Center for Devices and Radiological Health (CDRH). “Managing the side effects of chemotherapy is a critical component to overall health and recovery.” Image: The DigniCap scalp cooling system (Photo courtesy of Dignitana).

Smart Underwear Helps Battle Urinary Incontinence ovel panties combine smart textile technology, a wearable sensor, and an app to detect instances of leakage due to incontinence. The Carin line of incontinence underwear combines all three components to help women control urine leakage, such as in mothers who experience postpartum urine incontinence due to weakened muscles in the pelvic floor, or women with an overactive bladder. The first component is a microfiber fabric lining that is both absorbent and quick drying; the second is a discreet wearable sensor that measures the quantity of urine loss and sends the data to the third component, a companion app on a tablet or smartphone. The app analyzes the pattern of incontinence in multiple ways. The sensor can detect the user’s movements, providing information on which kinds of activity cause urine loss. Additionally, through the app, the user can upload information on any drinks they may have, so the algorithm can assess their effect. Users can then make appropriate lifestyle changes to minimize the number of releases, and begin to understand which drinks and activities make them more prone to involuntary leakage.

HospiMedica International May-June/2016

Because the system is able to detect the exact movements that stimulate urine release, it can identify which muscle fibers have been weakened, and develop a personal pelvic muscle training program to strengthen them. The user can thus focus on feeling and contracting pelvic floor muscles, then how to train them unconsciously, and finally how to integrate the program within daily life. The Carin line of underwear is a product of LifeSense (Eindhoven, The Netherlands; www. lifesense-group.com), and is available in white, lavender, or black, as well as an option of black lace. Urinary incontinence is about twice as common in women, and its likelihood rises with age. One large US study found that almost one-quarter of women in their 60s and 70s said they had urine leakage at least once a month; the rate rose to onethird among women in their 80s. Caffeine might promote UI because it is a diuretic, and people who already have an overactive bladder may be more susceptible to those effects, as even low doses of caffeine can speed muscle contractions in the bladder. Risk factors for UI include obesity and past pregnancies with vaginal births. LINKXPRESS COM

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PRODUCT NEWS MEDICAL X-RAY SYSTEM

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ULTRASOUND SYSTEM

MAMMOGRAPHY VIEWER

Control-X Medical

SonoScape Medical

Fujifilm

The Perform-X AT single/dual flat panel digital XRay system features a motorized tube stand, wall stand, and elevating four-way table. It allows users to select full automatic procedures including autotracking, APR positioning, and customized parking position.

The S12 color Doppler system features a 15-inch LED monitor with articulating arm, and a user-oriented, multi-language input keyboard. Four active transducer sockets are available for applications in cardiology, ob/gyn, and anesthesiology/emergency medicine/musculoskeletal.

The 3D mammography viewer creates 3D images by using two high-resolution images taken from different angles with one being a conventional 2D image. The images are displayed on two monitors, and a 3D image can be viewed through the half mirror by wearing polarized 3D glasses.

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Surprisingly High Occurrence of Concussions In Military Personnel with Blast-Related Injuries he results of a new study published in the online edition of the journal Radiology show that brain damage in active duty military personnel with blast-related injuries is evident in a surprisingly high percentage of cases. Concussion or Mild Traumatic Brain Injury (MTBI) is very common among US military personnel returning from fighting in Iraq, and Afghanistan, with over 300,000 of them diagnosed with MTBI between 2000 and 2015. Currently MTBI injuries are assessed mainly using behavioral observations, and symptoms such as post-traumatic amnesia, and loss of consciousness. The need for a more definitive marker spurred the research team to use advanced Magnetic Resonance (MR) brain imaging as a tool for assessing MTBI, and to try to link the acquired MRI data with subjective MTBI symptoms. The researchers are trying to use the technique to diagnose Post-Traumatic Stress Disorder (PTSD), which has similar symptoms to TBI, but different treatments. The ability to show evidence of micro-hemorrhages, hyper-intense areas, and softening or loss

of brain tissue in the advanced MRI scans also allows military personnel and their families to visualize the previously invisible “wounds of war.” Gerard Riedy, MD, PhD, US National Intrepid Center of Excellence (NICoE; Bethesda, Maryland, USA; www.nicoe.capmed.mil), said, “We were really surprised to see so much damage to the brain in the MTBI patients. It’s expected that people with MTBI should have normal MRI results, yet more than 50 percent had these abnormalities. This paper is just the tip of the iceberg. We have several more papers coming up that build on these findings and look at brain function, brain wiring, connectivity and perfusion, or brain blood flow. A scar on a brain scan is an objective finding. We start with the objective and build a foundation for the correct diagnosis of MTBI and then bring in the subjective measures later. An objective measure of traumatic brain injury can lead to proper therapies. Military traumatic brain injury is not a small problem for our country. Through this research, we hope to learn more about what the future entails for our military personnel who’ve suffered these injuries.”

Image: The susceptibility-weighted image shows extensive micro-hemorrhage (see arrows) consistent with diffuse axonal injury in a 25-year-old man with blast-related mild TBI (Photo courtesy of RSNA).

Technique Helps Treatment of Early Brain Glioma Tumors new technique for detecting and treating deadly brain tumors earlier using a nanotechnology Magnetic Resonance Imaging (MRI) contrast agent has been developed. The agent can pass through the blood-brain barrier and provides opportunities to treat normally fatal gliomas. Patients with cancerous gliomas have a median survival rate of 14 months after they are diagnosed. The new approach was developed by researchers at the Department of Neurosurgery of Penn State College of Medicine (Hershey, PA, USA; www.pennstatehershey.org/web/college), and was published in the Journal of Neuro-Oncology.

Current treatment options for patients with malignant glioma are surgery, chemotherapy, radiation therapy but the cancer often returns, surviving initial treatments, and follow-up MRI scans often are unable to catch the tumors in time. Existing MRI contrast agents can only find tumors after they are large enough to damage the blood-brain barrier. The Penn State research team found a way to created “smart fat cells” or liposomes that are able to pass the bloodbrain barrier in mice, and find cancerous gliomas earlier. The liposomes work together with Magnevist, a common MRI contrast agent, and are also studded with proteins that target receptors on glioma cells.

According to the researchers, smart fat cells may be used in the future to deliver chemotherapeutic drugs, and contrast agents, to brain tumor patients, to detect and remove cancer cells. James Connor, distinguished professor of neurosurgery, said, “Patients typically don’t die from the tumor they initially presented with. Rather, they die from new tumors that come back in other parts of the brain. The goal is to be able to get down to detecting single cancer cells. Ultrasound, with all of its good qualities, is disruptive to the blood-brain barrier, whereas we can get an agent to cross it without causing disruption.” HospiMedica International May-June/2016

Hybrid MR/CT Imaging Reveals Tumor Motion hybrid imaging approach that fuses magnetic resonance imaging (MRI) temporal information with computerized tomography (CT) can reveal lung and lung tumor motion. Researchers at the Agency for Science, Technology and Research (ASTAR; Singapore; www. research.a-star.edu.sg), Nanyang Technological University (Singapore; www.ntu.edu.sg), and other institutions have developed a novel hybrid imaging approach that is based on deformable image registration (DIR) and finite element method simulation to fuse a static three dimension (3D)-CT volume, acquired while the patient held his breath, and 3D motion information extracted from a four dimension (4D)-MRI dataset, thus creating a synthetic 4D-CT dataset. The result is images of the lungs that exhibit high spatial resolution, while at the same time accounting for lung movement due to breathing. When the researchers compared the synthetic 4DCT dataset with the acquired 4D-CT dataset of six lung cancer patients based on 420 landmarks, the average error was less than two mm. The hybrid approach also achieved a 40% error reduction over using only DIR techniques. The study describing the new hybrid imaging technique was published in the August 2015 issue of Medical Physics. “The method is expected to greatly assist clini-

cians when they target tumors in the lungs during radiotherapy,” said study author Soo Kng Teo, PhD, of ASTAR. “Encouragingly, some clinicians are thinking of applying our method to other organs, such as the liver, which also moves significantly with breathing. Also our computational method can combine information from different imaging methods to produce more comprehensive data sets.” Cancerous tumors in the lungs are often treated by irradiating them with high-energy X-rays, but this therapy is complicated by the fact that tumors are moving targets, due to the expansion and contraction of the lungs as the patient breathes. Currently, 3D-CT provides static high-resolution images, but at the cost of high radiation; in contrast, 4D-MRI does not employ ionizing radiation and allows continuous tracking of lung motion, but its low spatial resolution yields blurred images.

Image: A depiction of lungs obtained using the hybrid approach with motion denoted by the colored arrows (Photo courtesy of ASTAR).

Quantitative Ultrasound Helps Stage Fatty Liver new study suggests that computer-aided ultrasound could be used to stage hepatic steatosis, with a high correlation to magnetic resonance imaging (MRI) spectroscopy. Researchers at Radboud University Medical Centre (Nijmegen, the Netherlands; www.umcn.nl) conducted a pilot study in 14 patients on long-term home parenteral nutrition using a phased array ultrasound transducer connected to a calibrated ultrasound machine, with the radio frequency (RF) data converted into conventional B-mode images with the aid of computer software. All patients were also subjected to proton MRI spectroscopy measurement of liver fat content for reference. The results showed that computer-aided ultrasound parameters, similar to those in a previous validation study in cows, demonstrated significant correlation with fat content as measured by MRI spectroscopy, with the most significant parameters being residual attenuation coefficient and lateral speckle size. According to the researchers, the method shows promise as a noninvasive, easy, and inexpensive alternative to invasive biopsies or expensive MRI spectroscopy techniques. The study was published in the March 2016 issue of Ultrasound in Medicine & Biology. Steatosis in the liver, when it is not due to excessive alcohol use, is most often related to insulin resistance and to metabolic syndrome, and as a result may respond to treatments originally developed for other insulin-resistant states, such as diabetes mellitus type 2. Steatosis is also the most common liver disease of high-yielding dairy cattle during early lactation, making it a suitable animal model for studying liver fat accumulation.

HospiMedica International May-June/2016

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PRODUCT NEWS DR SYSTEM

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ULTRASOUND SYSTEM

DRF SYSTEM

Samsung Electronics Medical Equipment

SonoScape Medical

Varian Medical Systems

The GC85A comes with S-Detector, S-Vue, and SAlign imaging technologies. It features S-Share compatibility for reduced downtime, and auto positioning for faster operation.

The S9 Pro features a 50-degree, foldable, 15inch high-resolution color LCD screen with a 140degree opening angle, and abundant connection interface. A height-adjustable trolley, hard shell flight case, and internal battery make it suitable for various exam conditions and requirements.

The Nexus-DRF combines RF and DR capabilities in one imaging platform using various flat panel detectors. It runs on Windows 7 with an intuitive graphic user interface, and features an NVDIA K2000 series video card with Direct-X technology for image display.

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olumetric measurements of the evolution of medium-sized polyps may better inform clinicians in the management of the polyps than linear measurements. The volumetric measurements were helpful in determining whether a patient needed a colonoscopy, or whether surveillance using Computed Tomography Colonography (CTC) was sufficient. The research was carried out at the University of Amsterdam (Amsterdam, The Netherlands; www.uva. nl/en/home) and presented at the annual Radiological Society of North America (RSNA 2015) meeting in Chicago (IL, USA). The study had 70 participants, each with one or two 6–9 mm polyps, identified during primary CTC screening CTC. The patients underwent an additional CTC screening three years later. Patients with 6 mm or larger lesions had the opportunity to undergo colonoscopy and polypectomy. During the CTC screening exams semi-automated volumetric measurements were performed, and mean volume

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calculated for prone and supine volume measurements. Polyps whose volume increased more than 30% were classified as progressing, while those that decreased more than 30% were classed as regressing. Polyps between those parameters were classed as stable. The researchers then correlated Polyp growth to histopathological findings. Thirty-five percent out of a total of 95 polyps found in the initial CTC were found to have progressed. A total of 38% of the polyps remained stable, 27% regressed, and 14% were completely resolved. During the surveillance interval none of the polyps were found to have progressed to colorectal cancers or adenomas with high-grade dysplasia. The presenter of the study, Charlotte Tutein Nolthenius, MD, Department of Radiology, Academic Medical Center, University of Amsterdam,

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said, “Previous literature showed a 3–6.6% chance of harboring advanced histology for medium-sized (6–9 mm) polyps, but little is known about their natural course. CTC is probably the best method for determining longitudinal growth of these polyps, because we leave them in place allowing a reproducible localization and measurement. Image: Computed Tomography Colonography (CTC) of a progressing advanced adenoma polyp in the ascending colon on 3D images (Photo courtesy of University of Amsterdam / RSNA).

Brain Imaging Technology Could Help Study Parkinson’s Disease portable imaging device has identified differences in brain activation patterns associated with postural stability in people with Parkinsonian syndromes, according to a new study. Researchers at Drexel University (Philadelphia, PA, USA; www.drexel.edu) and Yeshiva University (YU; New York, NY, USA; www.yu.edu) used a portable functional near infrared spectroscopy (fNIRs) device as a direct online cortical probe to compare neural activation patterns in the prefrontal cortex, postural stability, and their respective interactions, in 269 older adults (mean 76 years, 56% women) without dementia. Of these, 26 patients had Parkinsonian syndromes; 117 had mild Parkinsonian signs; and 127 were healthy older adults who served as controls. The participants were asked to stand upright and

count silently for ten seconds while changes in oxygenated hemoglobin levels over prefrontal cortex were measured using fNIRs. The researchers simultaneously evaluated postural stability with center of pressure velocity data recorded on an instrumented walkway. The results showed that when compared to healthy controls and patients with mild Parkinsonian signs, the patients with Parkinsonian syndromes demonstrated significantly higher prefrontal oxygenation levels to maintain postural stability. The study was published in the November 6, 2015, issue of Brain Research. “Postural instability is a major risk factor for older adults. This initial study allowed us to measure brain activity in real time, in a realistic setting. It shows that there are indeed differences in the prefrontal cortex of healthy and Parkinsonian syndrome patients,” said

study coauthor biomedical engineer Meltem Izzetoglu, PhD, of Drexel University. “If we can monitor the cognitive component of staying balanced, then this could eventually lead to better treatment options for people with Parkinsonian syndromes or even Parkinson’s disease.” The prefrontal cortex is the brain region considered to be in charge of the orchestration of thoughts and actions in accordance with internal goals, and is responsible for higher-level processing, such as memory, attention, problem solving, and decision-making. When a person is learning a new skill, for instance, neural activity is greater in this region. Increasing evidence shows that in Parkinson‘s disease, profound dopamine depletion not only occurs in the striatum of the brain, but also in the prefrontal cortex, and this may be associated with cognitive and motor deficits. HospiMedica International May-June/2016

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PRODUCT NEWS MOBILE C-ARM

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MRI SCANNER

PET/CT SYSTEM

Siemens Healthcare

Neusoft Medical Systems

The Cios Alpha features a square flat-panel detector, expanded field of vision, and sharp images down to the submillimeter range, which are essential for guiding fine catheters and tools in the X-ray image. The Cios family of C-arms also includes the Fusion, Connect, and Select models.

The MAGNETOM Amira 1.5T offers the potential to shorten many exams and enable many patients to undergo scans in routine applications. It features DotGO MRI exam software to simplify protocol management and offer the right operating sequence for each scan to suit requirements.

The NeuSight PET/CT combines anatomic and functional imaging with qualified design and technology for tumor, brain and heart scanning. Key features include a large port and dual pillar bed to improve patient comfort, along with improved scan speed and accuracy for analysis.

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PET/CT System Addresses Clinical Indications In Oncology, Neurology, and Cardiology new Positron Emission Tomography/Computed Tomography (PET/CT) system enables clinicians to serve a wide range of patients and move into new service areas using commercially available PET tracers. The system automates previously manual tasks enabling users to address more indications in oncology, neurology and cardiology. The system uses 4mm Lutetium Oxyorthosilicate (LSO) crystals to provide rapid scintillation with a high light output, and the lowest possible achievable dose to visualize small lesions. The Siemens Healthcare (Erlangen, Germany; www.healthcare.siemens.com) Biograph Horizon system has features that help automate tasks, streamline workflow, and increase productivity and can perform a scan in less than five minutes. Image reconstruction occurs in parallel to acquisition and is ready 30 seconds after the scan. The QuantiQC feature runs overnight calibration and quality control procedures. The Biograph Horizon also features the syngo.via

Molecular Imaging Workplace image processing solution for measurements and reporting. Other features include automated tools to visualize diagnostic information in real time, automate prefetching, preprocessing, and display comparison of previous findings. The system also features Siemens ALPHA technology for automatic registration, and EQ/PET that can calculate precise changes in tumor uptake. Steve Holmes, Sales Director, Siemens Healthcare, said, “At a time when there is a demand to drive down cost while enhancing productivity, Siemens is well placed to support with technology capable of improving care pathways and maximizing investments. The Biograph Horizon provides a cost-effective PET/CT imaging solution that does not compromise on quality. As our smallest PET/CT system, it offers low power requirements

and a small footprint to ensure reduced operating and maintenance costs, with the flexibility to meet expanding clinical needs.” Image: The versatile Biograph Horizon PET/CT system offers premium performance at cost-effective ownership (Photo courtesy of Siemens Healthcare).

Gaming Technology Could Improve X-Ray Precision While Reducing Radiation Exposure he results of a new feasibility study have shown that a new technology based on the Microsoft (Richmond, WA, USA; www.microsoft.com) Xbox gaming system could afford a new approach to imaging patients. The feasibility study was presented at the annual Radiological Society of North America (RSNA 2015) meeting in Chicago, USA. The aim of the new imaging technology is to produce high-quality X-rays with minimal radiation exposure, especially for imaging children. Researchers at Washington University School of Medicine (St. Louis, USA; https://news. wustl.edu) adapted the hands-free Xbox technology using proprietary software developed for the Microsoft Kinect system. The software coupled

with the Kinect system was used to measure thickness of body parts, monitor motion, position, and the X-ray field-of-view, just before the X-Ray image was taken. The parameters were monitored in real-time to alert technologists of anything that could compromise image quality, reducing the need for additional images and radiation exposure. High-quality X-Rays are crucial for determining clinical diagnoses, and treatment. The new technology is especially useful for imaging children because they are more sensitive to radiation, and have a greater variation in body sizes. X-ray settings and radiation exposure depends on the thickness of the body part being imaged. Steven Don, MD, associate professor of radiol-

ogy at the Washington university’ Mallinckrodt Institute of Radiology, said, “The goal is to produce high-quality X-ray images at a low radiation dose without repeating images. It sounds surprising to say that the Xbox gaming system could help us to improve medical imaging, but our study suggests that this is possible. To achieve the best image quality while minimizing radiation exposure, X-ray technique needs to be based on body-part thickness. The gaming software has an infrared sensor to measure body-part thickness automatically without patient contact. Patients, technologists and radiologists want the best quality X-rays at the lowest dose possible without repeating images. This technology is a tool to help achieve that goal.” HospiMedica International May-June/2016

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Medical Imaging

MRI-Based Technology Identifies Stroke Recurrence Risk uantitative magnetic resonance angiography (QMRA) can be used to identify vertebrobasilar (VB) stroke patients who are at greater risk of having another stroke, according to a new study. Researchers at the University of Illinois in Chicago (UIC, USA; www. uic.edu), the University of Toronto (Canada; www.utoronto.ca), and other institutions conducted a prospective, blinded, longitudinal cohort study involving 72 patients with recent VB transient ischemic attack (TIA) or stroke, and 50% or more atherosclerotic stenosis or occlusion in VB arteries. The patients underwent large-vessel flow measurement using QMRA, and were also followed for two years at five academic medical centers as they continued receiving standard care from their neurologists, who were

blinded to QMRA flow status. The results showed that distal flow status was low in 25% of the patients and was significantly associated with risk for a subsequent VB stroke; 12and 24-month event-free survival rates of 78% and 70%, respectively, were found in the low-flow group, compared to 96% and 87%, respectively, in the normal-flow group. Distal flow status remained significantly associated with risk even when controlling for the degree of stenosis and location. Medical risk factor management at 6-month intervals, however, was similar between patients with low and normal distal flow. The study was published in on December 21, 2015, in JAMA Neurology. “At one year, the risk for patients with low blood flow was about five times as high as risk for patients with-

Image-Guided Treatment Option for Prostate Cancer Offers Alternative to Surgery he results of a new clinical study into the use of a minimally invasive, image-guided treatment option for prostate cancer show that it has less side effects and lower toxicity, than surgery. According to the researchers, the new procedure, based on Magnetic Resonance (MR) and ultrasound, can locate the exact location of the tumor and enable more precise treatment, and shorten recovery times, with less or no side effects for all stages of prostate cancer. The study involving more than 200 patients was carried out at the Prostata Center (Offenbach, Germany; www.prostate-center.org) and was presented at the annual Radiological Society of North America (RSNA 2015) meeting in Chicago, USA. The Irreversible electroporation (IRE) technique is a unique tissue-selective therapy that destroys cells leaving the intestinal wall, the sphincter, veins, arteries, and the intestinal wall intact. Precise image guided IRE kills cells using strong electric fields without radiation, or heat, are spared. Treatment with IRE shortens recovery time, and prevents possible erection, bladder control, and other problems. The research team evaluated data from 265 patients that had been treated using surgery, radiation therapy, and High-Intensity Focused Ultrasound (HIFU). The patients had stage T1-T4 (primary), and recurrent PCa, which had been brought under

HospiMedica International May-June/2016

control. Recurrence rates were 0/55 (Gleason < 7), 3/117 (Gleason 7) and 10/67 (Gleason > 7) during a follow-up period of up to 4 years. No IRE-related incontinence was observed during the study, even when the lower urinary sphincter was included in the treatment field. Two patients had a permanent loss of erectile function, 15 had a permanent reduction, and 27 a transient reduction that was resolved after 6 to 8 months. IRE toxicity for the rectum and bladder was also very low, even when they were affected by advanced stage cancer in patients who were no longer candidates for radiation treatment or surgery. Dr. Michael K. Stehling, primary author of the study, said, “The patients we have treated at The Prostata Center have had their cancers destroyed without the need for surgery, with a low incidence of side effects and in most cases have been back on their feet the next day. The data from this study confirms what we see every day, we have a very attractive approach for patients who are concerned about quality of life challenges and are considering options for the treatment of localized and late stage prostate cancer. Treating prostate cancer with minimal pain and minimal risk of impotence and incontinence, even in patients with advanced and recurrent cancer, with a one-time, one-day treatment, until recently, was unthinkable. The cutting edge technology of IRE makes this a reality.”

out low flow in the back of the brain. For these patients, the benefits of angioplasty probably outweigh the risks,” said senior author professor of neurological surgery Sepideh Amin-Hanjani, MD. “About three-quarters of patients didn’t have low blood flow in the vertebrobasilar region. These patients would not benefit from treatments aimed at opening the vessels, such as angioplasty; in fact, the procedure would put these patients at unnecessary risk.” The QMRA data was analyzed using noninvasive optimal vessel analysis (NOVA), a software program that can quantify the volume, velocity, and direction of blood flowing through any major vessel in the brain using standard MRI equipment. NOVA is a

product of Vassol (River Forest, IL, USA; www.vassolinc.com), and was developed at UIC by head of neurological surgery Professor Fady Charbel, MD, who is also a coauthor of the new study. Image: An MRI scan using NOVA technology (Photo courtesy of UIC).

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SURGICAL EQUIPMENT

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ATMOS MedizinTechnik

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The Atmos C 361 features a suction pump with at least 36 l/min, max-91 kPa and is ideal for continuous operation with less power requirements. Typical applications include endoscopy, gastroenterology, surgical practice, emergency room, surgical intensive care units, and hospital wards.

The NuBOOM S is an equipment management, visualization, and ergonomic boom that can be installed in less than a day. It is “furniture-like” instead of built-in ceiling infrastructure, making it ideal for upgrading ORs, office based-surgery centers, and hospital procedure rooms.

The MUSE is a minimally invasive GERD treatment system that includes a stapler, video camera, and ultrasonic sights to aid alignment. It allows a single user to perform a transoral anterior fundoplication using one instrument without making abdominal incisions.

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Endoscopic Video Analysis Assists Laparoscopic Surgery Training novel tracking system enables the study and assessment of surgical instruments movements within a simulator, helping to objectively measure surgical expertise. Developed by researchers at Universidad Politécnica de Madrid (UPM; Spain; www.upm.es), Jesús Usón Minimally Invasive Surgery Center (Cáceres, Spain; www.ccmijesususon.com), Delft University of Technology (The Netherlands; www.tudelft.nl), and other institutions, the endoscopic video analysis (EVA) Tracking System was designed to analyze the motions of laparoscopic instruments based on non-obtrusive video tracking technology. But unlike sensor-based tracking systems, EVA uses only computer vision techniques to obtain the spatial location of laparoscopic instruments, relying only on the acquired endoscopic camera image. The EVA Tracking System can be used to estimate multiple motion-based objective evaluation metrics, principally total travel path, speed of movement, average acceleration, the volume of space occupied, and motion smoothness. The system also

makes use of an algorithm that employs information of the laparoscopic instrument’s shaft edges in the image, the instrument’s insertion point, and the camera’s optical center to track the three-dimensional (3D) position of the instrument tip. To test the validity of the system, the researchers matched estimated EVA metrics with ones obtained by the TrEndo optical tracking system, with 42 participants – 16 novices, 22 residents, and 4 experts – asked to perform a peg transfer task in a box trainer. The metrics data were found to be able to predict the skills of a surgeon in a surgical simulator with a success rate of up to 83.3%, demonstrating a direct correlation between the previous experience of the surgeon and the simulation task being performed. “Laparoscopic surgery allows us to lessen the postoperative trauma and favoring a faster recovery of patients. The training of the required skills is complex and the surgeon has to learn indirect surgery through a monitor and without physical con-

tact with the inner body,” stated UPM in a press release. “In order to prevent accidents that can put patients at risk, it is required to develop environments that allow surgeons to acquire skills outside the operating room.” Image: Instrument tracking based on endoscopic video analysis (Photo courtesy of UPM).

Prophylactic Antibiotic Choice Impacts Postsurgical Infections rophylactic antibiotic choice impacts the risk of surgical site infection (SSI) rates in women undergoing hysterectomy, according to a new study. Researchers at the University of Michigan (Ann Arbor, USA; www.umich.edu), the University of Wisconsin (WISC; Madison, USA; www.wisc.edu), and other institutions conducted a retrospective cohort study of 21,358 hysterectomies performed from July 2012 to February 2015. Patients receiving a recommended preoperative antibiotic regimen were categorized into those receiving -lactams and those receiving an alternative antibiotic. Patients receiving non-recommended antibiotics were categorized into those receiving overtreatment and

those receiving nonstandard antibiotics. The primary outcome was a composite outcome of any SSI. The results showed that the overall rate of any SSI was 2.06%. The unadjusted rates of SSI were 1.8%, 3.1%, and 3.7% for -lactam, -lactam alternatives, and nonstandard groups, respectively. After adjusting for patient and operative factors within clusters of hospitals, as compared with the -lactam antibiotics, the risk of any SSI was higher for the group receiving approved -lactam alternatives or the nonstandard antibiotics. The study was published in the February 2016 issue of Obstetrics & Gynecology. “Compared with women receiving -lactam antibiotic regimens, there is a higher risk of surgical

site infection after hysterectomy among those receiving a recommended alternative or nonstandard regimen,” concluded lead author Shitanshu Uppal, MBBS, and colleagues. “Efforts to decrease surgical site infections could focus on adherence to recommended preoperative antibiotic guidelines and thorough evaluation of patient-reported penicillin allergies to increase the number of patients receiving lactam antibiotics.” SSIs may be the most frequent healthcare-associated infection (HAI) after asymptomatic bacteriuria, representing a high burden on patients and hospitals in terms of morbidity, mortality, prolonged length of hospital stay, and additional costs. Each year, approximately 500,000 surgical patients develop SSIs. HospiMedica International May-June/2016

Minimally Invasive Surgical Robot Benefits Surgeons and Patients novel robotic device increases the safety and reliability of various neurological and orthopedic procedures, without compromising established surgical protocols. The ROSA robotic assistant is an integrated multi-application console that acts as a reliable and accurate surgical assistant. With six degrees of freedom, the robotic arm architecture can accurately replicate the movements of a human arm, providing high dexterity while completing complex surgical procedures, as well as allowing complete freedom in a choice of trajectories. Advanced haptic capabilities help the neurosurgeon to easily guide instruments by hand, while remaining within the limits and restrictions established during the planning stage. The surgeon is able to easily interact with the robot without changing any of his surgical techniques, thus reaping the full benefits of robotic movement. A further advantage is a noninvasive and touch-free registration system that combines precise robotic movement with peripheral laser measurements to register patient volumes, without the use of invasive markers or a stereotactic frame. The ROSA Spine robotic assistant is a product of Medtech (Montpellier, France; www.medtech.fr), and has been approved by the US Food and Drug Administration (FDA) for brain and spine procedures. Robotics technology is making headway in practically every major surgical discipline, with the global demand particularly high for prostatectomy and hysterectomy procedures, as they are believed to offer greater safety, accuracy, and precision, thus leading to better clinical outcomes for the surgeon, patient and hospital management. Advanced imaging, higher degrees of freedom, intuitive interfaces, improved haptics feedback, and remote operation are being continuously developed to further strengthen the capabilities of surgeons.

Image: The ROSA robotic assistant (Photo courtesy of Medtech).

Skin Regeneration System Treats Diabetic Foot Ulcers cont’d from cover

cow collagen, and shark cartilage that serves as a skin replacement system. Once in direct contact with the excised wound or ulcer, it provides immediate wound closure and acts as a scaffold for cell migration, allowing for permanent regeneration of the dermal layer of the patient’s skin. The FOot Ulcer New DErmal Replacement (FOUNDER) study, a recent randomized clinical trial that enrolled 307 patients at 32 sites that was conducted under an investigational device exemption (IDE) issued by the US Food and Drug Administration (FDA), showed that patients treated with IDRT demonstrated a 59% improvement in the incidence of complete wound closure when compared to standard of care. The study was published in the November/December 2015 issue of Wound Repair and Regeneration. “Integra is pleased to announce the approval of IDRT for the treatment of diabetic foot ulcers,” said Peter Arduini, President and CEO of Integra LifeSciences. “This approval allows us to provide clinicians and their patients with a product backed by a robust clinical trial to treat the nearly one million non-healing DFUs that will occur this year. The nerve pathways that ensure that weight is automatically transferred from one foot to the other during prolonged standing are disrupted in diabetics, and as a result, they do not notice that their toes, heels, or the balls of their feet are too heavily loaded. The foot receives no relief, and pressure sores, ulcers, and infections may go unnoticed, leading to nerve and circulation problems in the feet, which reduce their perception of pain. Serious cases may even lead to amputation.

HospiMedica International May-June/2016

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INSTRUMENT TRAY

ENDOSCOPE

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The VisiClear captures and filters surgical smoke, removes odors, particulates and other potentially hazardous byproducts. It features an occlusion warning, filter life tracking, and programmable procedure modes for open tubing, electrosurgical pencil, and laparoscopic procedures.

The Intrusafe three-level system is for holding all bariatric instrumentation, and can accommodate any surgical instrumentation set. Using dividers and silicone holders, each instrument has its own place in the tray, which can be reconfigured to accommodate procedural and surgical preferences.

The EC-330 endoscope series features a 12.9mm distal end diameter and 4.2mm diameter forceps channel. A 140-degree viewing angle allows fullscale endoscopic scanning and shorter exam times, making it suitable for various therapeutic applications.

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Cooled Ablation System Treats Painful Spine Metastases new ablation system uses water-cooled radiofrequency (RF) probes to reduce patient pain when ablating metastatic spinal tumors. The OsteoCool RF Ablation System is intended for palliative treatment in spinal procedures by ablation of metastatic malignant lesions present in a vertebral body. The ablation system works together with the Baylis Pain Management Generator-TD (PMG-TD) to deliver the RF energy to the target ablation site. To cool the probes during the procedure, a tube kit connected to a pump unit is used to circulate water internally. A battery operated thermocouple monitor connects to a port on the PMG-TD to display the temperature detected. The system offers simultaneous, dual-probe capabilities, with the 17-gauge, bipolar probes available in three lengths, which may be used through a variety of cannula sizes. Since two ablation probes can be used simultaneously, the system supports a variety of scenarios that accommodate unique patient and procedural needs. The OsteoCool RF Ablation System was developed by Baylis Medical (Montreal, QC, Canada; www.baylismedical.com),

which sold the technology and intellectual property to Medtronic (Dublin, Ireland; www.medtronic. com) after receiving marketing approval from the US Food and Drug Administration (FDA). “The OsteoCool System expands our pain therapies portfolio. Our customers treat patients with balloon kyphoplasty who also have painful spinal metastases; the OsteoCool system gives physicians a way to treat that pain in a single procedure with a familiar, minimally invasive technique,” said Julie Foster, general manager and vice president of pain therapies in the Medtronic neuromodulation division. “The most common complaint associated with spine metastases is pain; it’s often progressive and significantly reduces the patient’s quality of life,” said interventional radiologist Sandeep Bagla, MD, of the Vascular Institute of Virginia (Woodbridge, VA, USA). “With the OsteoCool system, I can now ablate the patient’s painful tumor with a repro-

ducible procedure that’s appropriate for their unique anatomy.” In November 2105, Medtronic received expanded indications for Kyphon Xpede bone cement, which now includes clearance for the treatment osteolytic lesions. Where indicated, the OsteoCool bone access kit can be used for a subsequent, physician-directed procedure such as cementoplasty. Image: The OsteoCool RF ablation system (Photo courtesy of Medtronic).

Injectable Agent Makes Cancerous Cells Visible During Surgery esults from a trial published on January 6, 2015, in the journal Science Translational Medicine show how a new injectable agent can be used during soft-tissue sarcoma or breast cancer surgery to identified remnants of cancerous tissue. Cancer surgeons use Magnetic Resonance Imaging (MRI) and Computed Tomography (CT) scans as guides during excision of tumors and surrounding tissue, however traces of cancerous tissue around the tumor remain undetected and as a result are not removed, leading to additional surgery later, and radiation therapy. The trial was carried out at Duke University Medical Center (Durham NC, USA; https://

medschool.duke.edu) and included 15 patients undergoing surgery for soft-tissue sarcoma or breast cancer. The researchers tested the new injectable agent called LUM015 that makes tumor cells visible by causing fluorescence, and enables surgeons to find and take out all cancerous tissue in one operation. The research into the new imaging technology was made possible by a collaboration between scientists at Duke University Medical Center, Massachusetts Institute of Technology (MIT; Cambridge, MA, USA; http://web.mit.edu), and a company called Lumicell (Wellesley, MA, USA; www.lumicell.com). As a next step, researchers at Massachusetts General Hospital are evaluating the efficacy and safety of

LUM015 and the imaging technology in a trial with 50 women suffering from breast cancer. After that, the researchers plan to verify that the technology can reduce the number of second operations following surgery for the removal of breast cancer. David Kirsch, MD, PhD, professor at Duke University School of Medicine, and senior author of the study, said. “At the time of surgery, a pathologist can examine the tissue for cancer cells at the edge of the tumor using a microscope, but because of the size of cancer it’s impossible to review the entire surface during surgery. The goal is to give surgeons a practical and quick technology that allows them to scan the tumor bed during surgery to look for any residual fluorescence.” HospiMedica International May-June/2016

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Surgical Techniques

New Wrist Implant Could Alleviate Painful Arthritis

new partial wrist replacement could offer better movement than traditional implants for people seeking relief from painful wrist

arthritis. Developed at the Hospital for Special Surgery (HSS; New York, NY, USA; www.hss.edu), the KinematX midcarpal wrist hemiarthroplasty device is a modular partial wrist replacement designed to be a better anatomical match for a normal wrist than traditional implants, helping to preserve wrist motion needed for a range of activities. The implant, which utilizes modular components in various sizes to match a patient’s individual anatomy and more closely mimic normal wrist motion, replaces the proximal carpal bones in a procedure called wrist hemiarthroplasty. The researchers claim that the improved motion of the KinematX will enable patients to resume sports and other activities and that the modular nature of the device will allow the partial wrist replacement to be more easily converted to a midcarpal total wrist replacement if and when the need arises. They also believe the implant to be more durable than traditional wrist replacements, which only last 5 to 10 years. The technology has been licensed to Extremity Medical (Parsippany, NJ, USA; www.extremitymedical.com) who will be responsible for the manufacture and distribu-

tion of the new implant. “Wrist arthritis is one of the most common and debilitating conditions treated by hand surgeons. When conservative treatments fail to provide relief, patients often consider surgery,” said hand and upper extremity surgeon Scott Wolfe, MD, who co-developed the new device. “Because of the limitations of current surgical options, we set out to develop a better wrist replacement based on years of research into how the wrist moves.” “Traditional wrist surgeries often constrain the wrist to move in one plane at a time. During many activities, such as throwing a ball, hammering a nail or pouring a glass of water, the wrist doesn’t move in just one of these directions. It accomplishes the action by combining Image: The KinematX movements in both planes,” conclude Dr. midcarpal modular Wolfe. “Because of this, patients need to wrist hemiarthroplasty implant (Photo courtesy learn new ways to move their forearm of Extremity Medical). and arm to compensate for the change.” Seven surgeons from Canada, Euin Seattle (WA, USA). They will follow patients and rope, and Australia were trained in using the innorecord results in an international wrist replacevative device at the September 2015 meeting of ment registry to determine how they fare with the the American Society for Surgery of the Hand, held new prosthesis.

Bariatric Embolization Could Promote Weight Loss n experimental percutaneous procedure, which involves embolization of the left gastric artery, can lead to 50% reductions in excess weight, according to a new study. Researchers at Dayton Interventional Radiology (OH, USA; www. daytonir.com) performed the percutaneous procedure – dubbed bariatric or gastric artery embolization – using Bead Block, a formulation of tiny polyvinyl alcohol hydrogel microspheres that is made by Infiniti Medical (Menlo Park, CA, USA; www. infinitimedical.com). The microspheres are tinted blue to improve visualization and come in a variety of sizes and preloaded syringes to facilitate targeted embolization of tumors and vascular malformations. Prior to use, Bead Block is mixed with an iodinated contrast agent and injected under fluoroscopic guidance. The results showed that following embolization, one patient underwent a weight loss of nearly 20 kg (48.6% of her excess body weight); another patient, who was a diabetic, lost 12 kg (17% of her excess body weight) after the procedure, and a third lost 5 kg. A fourth patient lost only two and

HospiMedica International May-June/2016

a half kilograms, but according to the researchers suffered a depressive event during the trial, and may have overeaten to compensate. “Bariatric embolization is a promising treatment for obesity. It can be performed on an outpatient basis and has the potential to provide as much weight loss as is seen in gastric surgery,” said lead author and study presenter Mubin Syed, MD. He added that the researchers believe that gastric artery embolization reduces ghrelin – the “hunger hormone” – and that embolization of the left gastric artery does not appear to harm the stomach because the organ has a rich collateral blood supply. The experimental percutaneous procedure was conducted in four morbidly obese patients under a US Food and Drug Administration (FDA) experimental device exemption to determine if the larger Gastric Artery Embolization Trial for Lessening Appetite Nonsurgically (GETLEAN) study, which is currently recruiting, should be expanded. The pilot study will enroll morbidly obese patients with a body mass index (BMI) higher than 40 kg/m2 who are otherwise healthy. LINKXPRESS COM

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Surgical Techniques

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4K Endoscopy System Offers Four-Fold Higher Resolution new endoscopic surgical system integrates 4K Ultra high definition (UHD) technology to improve visibility and allow more precise and safer surgery. The Olympus (Tokyo, Japan; www.olympus-global.com) VISERA 4K UHD delivers images in both 4K (4096 x 2180 pixels) and UHD (3840 x 2160 pixels) resolution, thus providing four times more image information than Full HD, thanks to the Sony (Tokyo, Japan; www.sony. com) Exmor R CMOS image sensor in the camera head. The system incorporates an ultra telescope with an extra-low dispersion lens that reduces chromatic aberration, ensuring that it will consistently provide sharp depictions in true colors, even on the fringes of the visible edge. A one-touch autofocus feature delivers sharp pictures on the surgeon’s 55-inch screen at the push of a button, providing an immersive environment and sharp images in full 4K UHD brilliance. The Sony OptiContrast Panel guarantees high-contrast

and minimal glare images, while a magnified visualization function allows the surgeon to use the telescope fitted to the VISERA 4K UHD even at some distance from the section being operated on, while still delivering high resolution images. The 4K and UHD technology also provide surgeons with finer color calibration possibilities by broadening the gamut of color reproduction by a factor of 64, when compared to predecessor models featuring full HD technology. The enlarged color spectrum, encompassing around one billion colors, improves the visibility of edges and fine details of delicate tissue, such as blood and lymphatic vessels and nerves. The richer reproduction of reds also assists surgeons in ensuring that incisions are even more accurate. “The VISERA 4K UHD is part of our aim to provide surgeons with even better support in their challenging and high-precision work, and to thereby help improve clinical outcomes and the quality of life for pa-

tients,” said Frank Drewalowski, managing director of Medical Systems at Olympus Europa. “We are convinced that the 4K UHD technology will become a new benchmark in surgical endoscopy.” The VISERA 4K UHD was developed by Sony Olympus Medical Solu-

Navigation System Advances Image-Guided Precision Surgery novel on-the-fly navigation system supports advanced surgical procedures involving thoracic, abdominal, and pelvic soft-organs. The IQQA-Guide system is a precision three dimensional (3D) imaging analytics platform designed for abdominal biopsy, minimally invasive interventional procedures, and general surgery procedures. The system uses sophisticated registration algorithms and state-of-the-art electromagnetic tracking to provide fully quantified, patient-specific anatomic models that serve to provide surgical guidance and real-time tracking and referencing to anatomic features of interest. The models are derived from multimodality images, intended to support physicians in “seeing through” organ surfaces and quantitatively reference the anatomy during surgery. Physicians can thus locate, assess, and adjust the position of instruments relative to the full patient-specific anatomy of lesion, vessels, organs and segments, helping to reduce the need for additional intraoperative computerized tomography (CT)

scans. The IQQA-Guide system is a product of EDDA Technology (Princeton, NJ, USA; www.eddatech. com), and has been approved by the US Food and Drug Administration (FDA). “The IQQA Platform now covers preoperative planning, intraoperative navigation and monitoring, and postoperative assessment to complete the full cycle of imaging-guided precision treatment,” said Jianzhong Qian, PhD, President and CEO of EDDA Technology. “Powered by our precision 3D capabilities, IQQA-Guide may help facilitate the next generation of minimally invasive and robotic treatments in precision medicine.” The IQQA-Guide system is based on the IQQA platform, which provides fully quantitative real-time interactive and personalized solutions for advanced clinical applications including 3D quantitative analysis and visualization, automated volumetric organ/lesion segmentation and quantification, pre- and postoperative assessment, virtual planning & treatment simulation, intraoperative multimodality image guidance, and computer aided detection.

tions (Tokyo, Japan; www.sonyolympus-medical.com), a medical joint venture between Olympus and the Sony Corporation that was founded in 2013. Image: The VISERA 4K UHD control center (Photo courtesy of Olympus).

Real-Time Video Surveillance Improves Surgical Safety new study finds that thirdparty remote video auditing (RVA) with real-time feedback dramatically improves patient safety and efficiencies in the operating room (OR). Researchers at North Shore-LIJ Health System (Lake Success, NY, USA; www.northshorelij.com) conducted a cluster randomized study in a 23-operating room (OR) suite at the Long Island Jewish (LIJ) Medical Center (New Hyde Park, NY, USA) to evaluate the impact of RVA with realtime provider feedback on OR surgical checklist compliance. OR’s were randomized to receive or not receive real-time feedback on surgical safety checklist compliance and efficiency metrics via display boards and text messages, followed by a period where all 23 ORs received feedback. The main outcomes and measures were checklist compliance. The results showed that by using RVA, signin, time-out and sign-out compliance rates increased from 25%, 16%, and 32% during baseline phase to 91%, 95%, and 84% (respectively) during the all-feedback phase. In addition to driving significant patient safety im-

provements, RVA also improved turnover times in between cases by 14% for all scheduled cases and 20% for “fast” scheduled cases. The study was published on December 11, 2015, in BMJ Quality & Safety. “This study validates RVA technology as being able to significantly impact both surgical safety checklist compliance and OR efficiencies,” said senior author John Di Capua, MD, chair of the department of anesthesiology at North Shore-LIJ, and CEO of North American Partners in Anesthesia (NAPA; Melville, NY, USA; www. napaanesthesia.com). “It also demonstrates the importance of effective teamwork on improving patient safety.” “Beginning in 2008, North ShoreLIJ became the nation’s first health care provider to use video monitoring as part of our efforts to strengthen patient safety,” said Michael Dowling, president and CEO of North Shore-LIJ. “We are very pleased to be recognized by worldclass medical journal, BMJ Quality and Safety, for using RVA to drive significant improvements in patient safety and efficiencies in the OR.” HospiMedica International May-June/2016

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Surgical Techniques

Illumination Tool Reduces Gallbladder Removal Risk novel imaging solution utilizes backlit illumination of the biliary tree to reduce the risk of injury during laparoscopic cholecystectomy. Under development by researchers of the BioDesign team at the Hebrew University (HUJI; Jerusalem, Israel; www.huji.ac.il) and Hadassah Medical Center (Jerusalem, Israel; www. hadassah-med.com), the CholeVision dedicated laparoscopic tool will help surgeons avoid bile duct injuries and their devastating consequences by optically contrasting bile ducts and surrounding tissues, without changing the standard laparoscopic procedure. This is made possible due to characteristic visible red spectrum wavelength absorption by bile acids. By using a solid-state fiber optic light source which is inserted into a clip applier or a standard clamp, light at a red wavelength range of 600-700 nm preferentially absorbed by bile acids can be directed to illuminate the surgical field. When switching the color and direction of incident light, the bile duct anatomy can thus be made visible without the need for intravascular injection of fluorescent dyes, ultrasound imaging, or X-ray images, significantly reducing the complexity of the laparoscopic procedure. “The laparoscopic procedure is so simple and fast that surgeons are reluctant to make it complex by adding new imaging modalities,” said Muhammad Adileh, MD, a surgeon who led the HUJI BioDesign team. “We had to find a solution that

wouldn’t complicate things by changing the procedure or increasing operation time.” “We found that red light in the visible range is predominantly absorbed by bile acids in the biliary tree,” added Prof. Yaakov Nahmias, PhD, director of the HUJI Center for Bioengineering. “This is a significant discovery, allowing surgeons to carry out the standard laparoscopic procedure and identify bile ducts with a single flip of a button.” In traditional laparoscopic cholecystectomy, four incisions are made in the abdomen: one on the rim of the navel, one beneath the navel, and two be-

Therapeutic Ultrasound System Ablates Prostate Tissue new high-intensity focused ultrasound (HIFU) system offers an effective option for prostatic tissue ablation with a low occurrence of side effects. The Ablatherm HIFU system is intended for treating patients with localized prostate cancer (stages T1-T2) who are not surgical candidates due to age or comorbidities, those who prefer an alternative option, or for patients who failed previous radiotherapy (RT) treatment. The system itself consists of a treatment module, a control module, and a probe with both treatment and imaging transducers. After a spinal epidural or general anesthetic (GA) is administered, the patient lies down on his right lateral decubitus and stays in this position throughout the treatment. The Ablatherm HIFU probe is then introduced in the rectum, and the imaging transducer scans the prostate gland to plan robotic treatment. Once the ablation sequence is finalized, the treatment transducer emits HIFU ultrasound in the prostate gland; at the focal point – where the ultrasound waves are focused – the absorption of the ultrasound emission beam creates a sud-

HospiMedica International May-June/2016

den temperature increase, to around 85 °C, which destroys the tissue in the targeted zone. The Ablatherm HIFU system is a product of EDAP TMS (Vaulx-en-Velin, France; www. edap-tms.com), and has been approved by the US Food and Drug Administration (FDA). “This clearance represents a unique opportunity for EDAP and its superior HIFU technology to penetrate the largest prostate market in the world in the same way it has emerged as the leading HIFU technology in Europe,” said Marc Oczachowski, CEO of EDAP TMS. “The pieces are in place to begin deploying Ablatherm devices in the US very quickly, and we look forward to bringing the technology to urologists as well as patients in need.” HIFU technology is based on nonlinear acoustic mathematical optimization methods to analyze and simulate the propagation of sound in material. The information is then used to enhance the shape of an acoustic lens in such a way that that ultrasound pressure is focused precisely on the location of the tissue to be ablated, while the surrounding tissue retains as little damage as possible.

neath the navel and to the right. A laparoscope and surgical instruments are passed into the interior of the abdomen to aid the surgeon in removal of the gallbladder. The most common reason for cholecystectomy is cholelithiasis, caused by gallstones trapped inside the gallbladder duct that trigger intense abdominal pain that usually lasts between one and five hours. Image: A surgeon using the CholeVision dedicated laparoscopic tool during a cholecystectomy (Photo courtesy of the Hebrew University, Jerusalem, Israel).

PRODUCT NEWS LED SURGICAL HEADLIGHT

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INTUBATION SYSTEM

MOBILE C-ARM

Enova Illumination

Medcom Flow

Ziehm Imaging

The Cyclops XLT-225 LED with 225,000 lux has an adjustable aperture ranging from 2 inches to 5 inches/5.08cm to 12.7cm in diameter. Its coaxial design allows adjustment to be made as per height and angle of view requirements, making it ideal for deep cavity procedures.

The TotalTrack VLM consists of a video-laryngeal mask for allowing patient intubation and ventilation under direct visualization through a camera of what is happening inside the glottis of the patient and vocal cords. It can also aspirate laryngeal and gastric secretions at the same time.

The Vision RFD 3D combines 2D and 3D functionality to offer full intraoperative control in high-end applications in orthopedics, trauma and spine surgery. With its 30 cm by 30 cm flat-panel and up to 7 cervical vertebrae in one scan volume, it offers the largest 3D image volume available.

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Point of Care Microscope Helps Identify Cancer Cells handheld miniature microscope could examine tissues at the cellular level right in the operating room, helping surgeons determine the extent of tumor resection. Developed by researchers at the University of Washington (UW; Seattle, USA; www.washington. edu), Memorial Sloan-Kettering Cancer Center (MSKCC; New York, NY, USA; www.mskcc.org), and other institutions, the microelectromechanical systems (MEMS) line-scanned (LS) dual-axis confocal (DAC) microscope has a 12-mm diameter distal tip specifically developed for clinical point-of-care (POC) pathology examination. The dual-axis architecture surpasses conventional, single-axis confocal configuration by reducing the background noise generated by out-of-focus images and scattered light. The use of line scanning enables scan rates of at least 16 frames per second (FPS), which helps mitigate motion artifacts common when using handheld devices. The researcher also developed a method to actively align the illumination and collection beams in a DAC microscope through the use of a pair of rotatable alignment mirrors. Finally, the incorporation of a custom objective lens with a small form factor enables the device to achieve an opticalsectioning thickness of 2 micrometers with a lateral resolution of just 1.1 micrometers. The researchers successfully demonstrated that

the miniature POC microscope has sufficient resolution to see subcellular details, comparable to those produced from a multi-day process at a clinical pathology lab, which is the current gold standard for identifying cancerous cells. They hope that after testing the microscope’s performance as a human cancerscreening tool in vivo, it could be used during surgeries or other clinical procedures within the next 2-4 years. The study describing the development process was published in the January 2016 issue of Biomedical Optics Express. “Surgeons don’t have a very good way of knowing when they’re done cutting out a tumor. They’re using their sense of sight, their sense of touch, preoperative images of the brain, and oftentimes it’s pretty subjective,” said senior author Jonathan Liu, PHD, a UW assistant professor of mechanical engineering. “Being able to zoom and see at the cellular level during the surgery would really help them to accurately differentiate between tumor and normal tissues and improve patient outcomes.” “The microscope technologies that have been developed over the last couple of decades are ex-

pensive and still pretty large, about the size of a hair dryer or a small dental X-ray machine,” added study coauthor Milind Rajadhyaksha, MD, of MSKCC. “So there’s a need for creating much more miniaturized microscopes. Making microscopes smaller, however, usually requires sacrificing some aspect of image quality or performance such as resolution, field of view, depth, imaging contrast or processing speed.” Image: The handheld MEMS microscope (Photo courtesy of Dennis Wise/University of Washington).

Nerve Cap Facilitates Management of Symptomatic Neuromas n innovative device reduces painful neuroma formation, facilitating tissue repair and regeneration following nerve resection. Neurocap is a transparent tubular bioresorbable polymer cap that serves as a synthetic nerve covering. It was designed to help treat symptomatic neuromas by isolating the nerve stump from surrounding soft tissues, preventing the ingrowth of fibrous tissue into the nerve. The caps transparency allows for efficient stump positioning and early observation of blood

clots, while semi-permeable properties help to maintain the influx of nutrients and other factors required for optimal nerve regeneration. The Neurocap is a product of Polyganics (Groningen, The Netherlands; www.polyganics.com), and has been approved by the US Food and Drug Administration (FDA). “Neuroma-induced neuropathic pain and morbidity can seriously affect the quality of a patient’s daily life,” said Rudy Mareel, CEO of Polyganics. “We offer orthopedic and hand surgeons a valuable new

tool that contributes to the clinical management of neuromas and can improve the daily life of patients.” Symptomatic neuroma can occur following nerve repair and amputation procedures; there is no known solution to prevent or treat neuromas effectively. Current approaches for treating neuromas are based on surgical removal of the neuroma and surrounding scar tissue and subsequent placing of the nerve stump in tissue, subjected to minimal mechanical stimulation. HospiMedica International May-June/2016

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Surgical Techniques

Kidney Injury Common Following Vascular Surgery erioperative acute kidney injury (AKI) is common in patients undergoing vascular surgery, and is associated with a high risk for cardiovascular-specific mortality, according to a new study. Researchers at the University of Florida (Gainesville, USA; www.ufl.edu) conducted a single-center study involving 3,646 patients over a period of ten years to determine the association between kidney disease and long-term cardiovascular-specific mortality following vascular surgery. The main outcomes and measures of the study were perioperative AKI, presence of chronic kidney disease (CKD),

Nitric Oxide Protects Kidneys During Cardiac Surgery dministering nitric oxide (NO) during prolonged cardiopulmonary bypass procedures may help protect the kidneys, according to a new study. Researchers at Massachusetts General Hospital (MGH; Boston, MA, USA; www.massgeneral.org) conducted a double-blind, randomized study that enrolled 217 patients undergoing surgical replacement of multiple heart valves in procedures expected to take more than 90 minutes at a single center in China; average time on cardiopulmonary bypass was 132 minutes (placebo group) to 137 minutes (NO group). Patients were randomized to NO, which was delivered via the oxygenator during cardiopulmonary bypass and via the ventilator for 24 hours after surgery, or to placebo. The results showed that acute kidney injury – defined as a 50% increase in serum creatinine within 7 days of surgery, or a 0.3-mg/dL increase in serum creatinine within 2 days of surgery – was reduced by 22% among those who received NO; in all, acute kidney injury was observed in 63% of the 112 control patients and 50% of the 105 NO patients. No serious adverse events occurred in either group, but mortality rates trended lower with the intervention, as did need for dialysis after surgery. The study was presented at the annual American Heart Association (AHA) Scientific Sessions, held during November 2015 in Orlando (FL, USA). “Acute kidney injury is the most common complication after cardiac surgery with prolonged cardiopulmonary bypass, and is associated with hemolysis and high levels of free hemoglobin that cause the depletion of NO which is associated with acute kidney injury,” said lead author and study presenter anesthesiologist Lorenzo Berra, MD. “The administration of exogenous NO causes the oxidation of ferrous oxyhemoglobin and would decrease the risk of kidney injury by reducing the plasma depletion of NO.” NO has been identified as an important molecule with versatile roles in human physiology, including selective pulmonary vasodilation, bronchodilation, and pulmonary surfactant activities to improve ventilationperfusion mismatch and hence oxygenation. The clinical effects of NO that have been reported include reduction of right heart load, reduction of ischemia, reduction of hypoxemia, inhibition of platelet aggregation, and anti-inflammatory, fungicidal, virocidal, and bactericidal effects.

HospiMedica International May-June/2016

and overall and cause-specific mortality. Kidney disease constituted the main covariate, after adjusting for baseline patient characteristics, surgery type, and admission hemoglobin level. The results showed that perioperative AKI occurred in 49% of the patients, with CKD present in 14%. The top two causes of death in the study cohort were cardiovascular disease (54%) and cancer (11%). The adjusted cardiovascular mortality estimates at 10 years were 17% for patients with no kidney disease; 31% for patients with AKI without CKD; 30% for patients with CKD without AKI; and 41% for patients with both AKI and CKD. The study was published on December 23, 2015, in JAMA Surgery. “These findings reinforce the importance of preoperative risk stratification through application of consensus staging criteria for CKD using estimated glomerular filtration rate and albuminuria for all patients undergoing major vascular surgery,” conclud-

ed lead author Azra Bihorac, MD. “Risk stratification for AKI using clinical scores and urinary biomarkers similarly can help to direct the implementation of simple and inexpensive preventive strategies in the perioperative period that could prevent or mitigate further decline in kidney function.” AKI is an abrupt loss of kidney function that develops within 7 days and is generally caused by renal ischemia, exposure to harmful substances, an inflammatory process in the kidney, or an obstruction of the urinary tract, which impedes the flow of urine. AKI may lead to a number of complications, including metabolic acidosis, high potassium levels, uremia, changes in body fluid balance, and effects on other organ systems. Those who experience AKI may have an increased risk of CKD in the future. Management includes treatment of the underlying cause and supportive care, such as renal replacement therapy.

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SURGICAL INFORMATION SYSTEM

CONTENT MANAGEMENT SYSTEM

Nihon Kohden

Brainlab

Agfa HealthCare

The CNS-9601 features a 19-inch touch screen with nine different screens time-synchronized with each other for reviewing the same patient event in different ways. The parameters can be changed with a touch or click, and a multi-patient alarm event window helps reduce false alarms.

The Buzz digital O.R. is a central multi-touch information hub that routes, displays, interacts, streams, records and enhances medical images, software content and videos. It includes a 42-inch full HD touch display, industrial-grade workstation, and integrated sound system.

The Enterprise Content Management System features workflow capabilities that facilitate the capture, archiving, access, and sharing of any data. It allows health systems to reduce/eliminate physical storage by digitally archiving medical documents within the EMR/administrative workflows.

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Hospital to Use FitBit to Measure Patient Mobility edars-Sinai Medical Center (Los Angeles, CA, USA; www.cedars-sinai.edu) is conducting a study to see if using an activity bracelet could help assess if oncologic patients are active enough for chemotherapy. The short, two-week trial will enroll 30 patients in advanced stages of cancer who are ambulatory, over 18, and have access to an internet-connected smartphone. The trial will mainly be a feasibility study, seeing how effective a Fitbit (San Francisco, CA, USA; www.fitbit.com) activity bracelet, as well as questionnaires, are at monitoring the target population. All 30 patients will be given Fitbit Charge HR device and will be asked to wear it at all times, other than in the bath and other times the tracker would be submerged. The patients will also fill out questionnaires at two oncologist visits during the trial period, and again at a six-month follow-up. Researchers will also review mortality and hospitalization for the subjects, as well as whether they wore the device as directed. They will also examine whether the combination of the Fitbit device and the patient-reportedoutcome questionnaires can help physicians screen

patients for subjective measures such as fatigue, distress, pain, and trouble sleeping, which patients can tend to under-report. “What we know is that individuals who are up and about tend to be more able to tolerate chemotherapy and have a greater potential for benefitting from it,” said lead investigator Arvind Shinde, MD, of the departments of supportive care medicine, hematology, and oncology. “People who are spending more time in bed usually get harmed by the treatment we give, even if the cancer is responsive to the treatment.” “A 30-patient study is not enough to give us all the data we need; the two-week trial is something of a dry run to get the kinks of data collection ironed out. The next step will be to do a larger study across multiple tumor types and follow people longitudinally for a much longer period of time,” added Dr. Shinde. “We can see how they do as they progress through their treatments, follow their ups and downs. We’ll be able to get changes over baseline and create a better algorithm for this assessment.” The Fitbit Charge HR is an activity wristband

that offers continuous heart rate monitoring for better estimation of daily activity, tracking workouts, and monitoring resting heart rate and sleep quality. The advanced tracking records daily steps and calories by day and sleep by night, switching between modes based on movement and heart rate data. The device is linked by an app to a smartphone, allowing real time monitoring of daily data. The Charge HR is available in a range of colors, including black, plum, blue, teal, and tangerine. Image: The Fitbit Charge HR activity wristband (Photo courtesy of Fitbit).

Philips Promotes New Telehealth Service in Indonesia oyal Philips (Philips; Amsterdam, The Netherlands; www.philips.com) has entered an agreement with Indonesian Sijunjung Regency (Muaro Sijunjung, Indonesia; www.sijunjung.go.id) to provide mobile obstetrics monitoring (MOM) in the West Sumatra region. MOM is a scalable, smartphone-based digital health service designed to identify mothers-to-be who are at high risk of pregnancy-related complications and to help reduce maternal mortality rates. It enables midwives in remote locations to share vital measurements, observational data, and mobile ultrasound images with obstetricians and gynecologists in larger hospitals and collaborate with them for improved decision making during pregnancy. The service features two mobile phone apps; the first allows midwives to collect vital measurement da-

ta, such as weight, blood pressure (BP), and temperature, and synchronize it to the MOM web portal; the second app lets doctors track the data to review a woman’s progress. Specialists at regional primary care centers can also access the data via the web portal to monitor women’s conditions in real-time and identify high-risk pregnancies via a dashboard interface. Training and education are also provided as part of the service. In a one-year pilot project in collaboration with Bunda Medical Center (Padang, Indonesia; http://bunda.co.id/rsucbmcpadang) that monitored 650 pregnancies, the Philips’ MOM solution increased the early detection of high-risk pregnancies three fold and helped expectant mothers to receive the medical monitoring and treatment they needed for a safe delivery. According to Philips, not a single woman died from preventable causes related to preg-

nancy and childbirth through early monitoring and risk stratification. “Indonesia, with 255 million people living on more than 900 islands, still struggles with one of the highest rates of maternal death in the world, partly due to the lack of access to healthcare services,” said Jeroen Tas, CEO of Healthcare Informatics, Solutions, and Services at Philips. “With the roll-out of our mobile obstetrics monitoring solution in West Sumatra we are helping to give people access to skilled healthcare personnel and the right technology at the right time. It’s a clear example of how digital technologies can facilitate preventative care and have a tremendous impact on the quality of care.” The MOM telehealth service is planned to be introduced in other regions in Indonesia, India, and Africa in late 2016. HospiMedica International May-June/2016

Adaptive Monitor Adjusts To ICU Display Needs

Health IT I

n intelligent proxemic monitor interfaces with medical equipment and the hospital information system (HIS), displaying pertinent vital signs of intensive care unit (ICU) patients. Developed by researchers at the Fraunhofer Institute for Telecommunications, Heinrich-Hertz-Institut (HHI; Berlin, Germany; www.hhi.fraunhofer.de), the smart monitor can be controlled by contact-free gestures and voice commands. Three different cameras and a microphone scan the area in front of the monitor; using the video data, built-in software of analyzes whether there are people in the room, how far away they are from the screen, and what movements they are making. Depending on their distance from the monitor, the display is modified for optimum graphics. The monitor distinguishes between near, medium, and far distances, with the cameras covering a maximum of four meters; as the viewer gets closer, the screen displays more detailed information. From the medium distance, the cursor can also be controlled with arm movements, and commands or short reports can be input by voice. With pre-programmed gestures, for example, a video call can be started to consult with other physicians within or outside of the hospital. The user interface is web-based, so it is also suitable for mobile devices, such as tablets, at the bedside, as well as in the control room. NE “We have given the monitor eyes and ears so as to DES W IGN allow for multimodal interaction between the user and the system. Our software records distances and movements of the user in a contactless manner, interprets them, and converts them into commands for operating systems or machines,” said Paul Chojecki, of WORLD’S MEDICAL PRODUCT MARKETPLACE the HHI department of vision & imaging technology. “Another advantage of the gesture control is that the doctor or health care provider does not have to touch the devices directly. The obligatory hand hygiene is sometimes forgotten, and viruses as well as bacteria SIGN UP are carried from room to room.” FOR FREE! The system also evaluates the data of the medical devices on the basis of the smart alarm design of the partners to the project, the medical engineering department of Aachen University Hospital (Germany; www.ukaachen.de). The evaluation helps to prevent false alarms, since current devices do not exceed determined pre-set limits, thus often missing some relevant factors necessary to comprehensively assess a risk situation.

Image: The proxemic monitor as designed for ICU coverage (Photo courtesy of Fraunhofer HHI).

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Connecting Buyers with Suppliers Worldwide Reach new sources of supply Identify latest products and technologies Send inquiries directly to suppliers Receive latest product alerts Chat live with suppliers TradeMed provides a sophisticated yet easy-to-use global B2B platform for sourcing medical equipment. TradeMed connects buyers and sellers worldwide through a safe, secure and dynamic network. Solely dedicated to medical products, TradeMed is the premier choice for medical suppliers, hospital decisionmakers and buyers worldwide, regardless of size or budget.

PRODUCT NEWS MRI SOFTWARE

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RADIOLOGY EDUCATION TOOL

CLOUD-BASED NETWORK

Hitachi Medical Systems

Calgary Scientific

Siemens Healthcare

The Evolution 5 has nearly 40 new features and improvements. These include the integration of an image processing algorithm, a reconstruction task protocol that reduces redundant noise pickup, and an optimized fast spin-echo sequence in which images have greater uniformity and contrast.

The RadIQ provides hands-on case review via mobile devices and simulates how radiologists and cardiologists review images. It eliminates the burden of in-person training and takes the extra step of ensuring images are of diagnostic quality, guaranteeing a real world, mobile experience.

The teamplay network helps link hospitals and healthcare experts, and enables them to exchange data and pool their knowledge. It gives users the power to analyze, understand, optimize and collaborate with healthcare professionals around the world.

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3D Printed Models of DICOM Images: Critical for Medical Care he use of 3D printed models of DICOM images can change the way doctors are trained, and how they communicate with their patients. The research was presented at the annual meeting of the Radiological Society of North America (RSNA 2015). The research shows that despite the challenges that still need to be overcome before 3D models printing reaches its full potential in radiology, the impact of 3D printing could become the standard. According to Frank Rybicki, MD, PhD, professor, Department of Radiology, University of Ottawa Faculty of Medicine (Ottawa, Canada; http:// med.uottawa.ca/en), radiologists need to invest the time to learn 3D model printing methods. Dr. Rybicki suggests that printing of medical

models from Computed Tomography (CT) and Magnetic Resonance (MR) images should become part of radiology departments. Advanced imaging modalities and protocols need to be able to generate source DICOM images that can be used for 3D printing. Radiologists could use 3D printed models of DICOM images for tactile feedback, and tangible depth information of anatomic, and pathologic states. Existing obstacles to the mainstream adoption of 3-D printing include a consensus in terminology, cost, training, materials, equipment, and guidelines. Dr. Rybicki, said, “If we’re going to get reimbursement, we need a single reporting standard for 3D printing, and reimbursement will be a major hurdle. All payors know that we need 3D printing, and that it will eventual-

ly be reimbursed as the demand continues to swell. This will happen as we accumulate more data, and then develop guidelines regarding appropriate utilization. While there are many pressures to contain costs, data is beginning to show that the generation of 3D models is cost-effective for several applications, particularly when the model saves time in the operating room. 3D printing is a completely dis-

ruptive technology in general and in medicine. It will change the way that doctors do procedures. It will change the way we teach young physicians. The next natural step in the progression of technology is 3D printing.” Image: Three-dimensional (3D) printed models are increasingly being used for planning complex orthopedic interventions (Photo courtesy of RSNA).

Medical Device Manufacturers Required to Include Cybersecurity Features cont’d from cover

may arise throughout a device’s entire lifecycle. A structured and systematic comprehensive approach that responds in a timely fashion to identified vulnerabilities is thus recommended. For the majority of cases, actions taken by manufacturers to address cybersecurity vulnerabilities and exploits should include routine updates or patches, for which no advanced notification, additional premarket review, or reporting under FDA regulations is required. For a small subset of cybersecurity vulnerabilities and exploits that may compromise essential clinical performance of a device and present a reasonable probability of serious adverse health consequences or death, the FDA would require medical device manufacturers to notify the agency.

In cases where the vulnerability is quickly addressed in a way that sufficiently reduces the risk of harm to patients, the FDA does not intend to enforce urgent reporting of the vulnerability to the agency, if certain conditions are met. These include no serious adverse events or deaths associated with the vulnerability; that within 30 days of learning of the vulnerability, the manufacturer notifies users and implements changes that reduce the risk to an acceptable level; and that the manufacturer reports the vulnerability, its assessment, and remediation to its Information Sharing Analysis Organization (ISAO). “All medical devices that use software and are connected to hospital and health care organizations’ networks have vulnerabilities; some we can proactively protect against, while others require vigilant monitoring and timely remediation,” said

Suzanne Schwartz, MD, MBA, associate director for science and strategic partnerships and acting director of emergency preparedness/operations and medical countermeasures in the FDA’s Center for Devices and Radiological Health (CDRH). “The FDA is encouraging medical device manufacturers to take a proactive approach to cybersecurity management of their medical devices. Only when we work collaboratively and openly in a trusted environment, will we be able to best protect patient safety and stay ahead of cybersecurity threats,” continued Dr. Schwartz. “Today’s draft guidance will build on the FDA’s existing efforts to safeguard patients from cyber threats, by recommending medical device manufacturers continue to monitor and address cybersecurity issues while their product is on the market.” HospiMedica International May-June/2016

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Advanced Safety Tester Analyzes Diverse Medical Devices n upgraded dedicated tester meets international standards for in-service and postrepair safety testing of 24 V and 48 V DC medical electronic devices. The Rigel 62353 Plus tester offers a range of tests without the need for mains power, and is thus capable of conducting battery-powered insula-

tion and earth/ground bond testing in complete freedom during the installation process, as well as eliminating the inconvenience of trailing mains cables. The tester comes with four separate insulation test voltages (50 V DC, 100 V DC, 250 V DC, and 500 V DC), providing more flexibility in meeting routine safety testing for

Clearance for New Oncological Imaging Analytics Software new analytics software package intended to increase radiologists’ workflow efficiencies for oncological cases, and advanced decision support has received US Food and Drug Administration (FDA) 510(k) clearance. The software package features a quantitative imaging dashboard with time-sequenced Electronic Health Record (EHR) information, image characterization, and image tracking. Another feature is the ability to track a tumor or nodule over multiple, spatially registered imaging exams to show whether the cancer is stable, shrinking, or growing. Visualizing changes in the structure of cancers is important for monitoring and/or adjusting the treatment regime of a patient. The imaging analytics package was

developed by HealthMyne (Madison, WI, USA, www.healthmyne.com), a company that provides imaging informatics data mining solutions, and solutions for automating data capture, and structured reporting. EHR information on the software dashboard is provided by Epic Systems (Verona, Wisconsin, USA; www.epic.com). The HealthMyne software can be used for automatic identification of nodule growth in lung cancer screening programs, which provides an indication of potential malignancy of a nodule, and additional follow-up treatment that may be necessary. In addition, in view of the large increase in the number of cancer treatment options available today, the HealthMyne package can be used to provide quantitative insight and improve clinical decision-making.

Healthcare Providers Increasingly Adopt Enterprise Imaging Workflow Solutions he proliferation of clinical IT systems is leading to a dramatic rise in the market for enterprise medical imaging workflow solutions for healthcare providers. Healthcare providers need to rationalize their increasingly complex imaging Internet Technology (IT) systems, and regain control and oversight of the systems. Many healthcare providers are reshaping the scope and goals of their enterprise imaging strategies. One enterprise medical imaging workflow solutions provider, Laurel Bridge Software (Newark, DE, USA; www.laurelbridge.com), has experienced dramatic growth during the past year, 2015. Part of this growth has been due to consolidation between healthcare providers, which creates larger and increasingly complex healthcare IT systems that need to be interoperable. Additional challenges include cost reduction, effi-

HospiMedica International May-June/2016

ciency, and performance. Leading healthcare providers are working to build a comprehensive enterprise imaging strategy, and ease access and sharing of medical information with the aim of automating enterprise imaging workflow mechanisms, using a strategic cross-functional approach. Mark Blair, Laurel Bridge Software president, said, “We are seeing an increasing number of large health systems looking to solve numerous complex, interrelated image sharing and distribution problems that have resulted from a recent merger or acquisition. These organizations, often led by cross-functional IT teams, want easily implemented, proven IT solutions that provide flexibility and control over clinical imaging workflow challenges that typically span non-radiology clinical departments and multiple facilities. This is a dramatic shift from the radiology-centric workflow requirements of the past.”

increasingly popular equipment running on 24 V DC and 48 V DC, such as operating tables, lights, and mobile X-rays. Other design features include an earth bond “zap” circuit that preconditions contact resistance by using a high current, low energy pre-pulse. In addition, the upgraded tester can measure and warn of secondary earth paths (common in hospitals) and which may seriously affect the validity of leakage measurements if undetected. The automatic warning ensures users are made aware when invalid readings are made, providing correct and accurate test results every time. The comprehensive testing capability of the safety tester is supported by a large internal memory for the storage of test results, with stored test data being transferred via Bluetooth technology to a PC-based asset management and test records databases for maximum traceability. In conjunction with the comprehensive MedeBase database software, creation of test sequences and the ability to produce professional test certificates is simplified. The tester allows testing of up to

Health IT

two individual applied parts from different modules in fully automatic, semiautomatic, or manual test modes. The Rigel 62353 Plus tester is a product of Rigel Medical (Durham, United Kingdom; www.rigelmedical. com), and is in line with the internationally recognized IEC 62353, NFPA 99, and AN/NZ3551 in-service test standards. Image: The Rigel 62353 Plus tester (Photo courtesy of Rigel Medical).

Hospital News I

Chinese-UK Partnership to Invest In Chinese Hospital Development anda Group (Beijing, China; www.wanda-group. com) and International Hospitals Group (IHG; Gerrards Cross; United Kingdom; www.ihg.co. uk) will build three comprehensive international hospitals in Shanghai, Chengdu, and Qingdao. The investment marks the largest of its kind in the healthcare sector for a Chinese company and is to be the first hospital project managed and operated by IHG in China, under the brand name IHG Wanda International Hospital. Under the terms of the agreement, IHG will appoint the director of each hospital, and will also select medical staff. The 1,000-bed IHG Wanda International Hospital in Shanghai is scheduled to undergo construction in the first quarter of 2016, as is the 500-bed IHG Wanda International Hospital in Chengdu, which will be located in the Qinhuangsi Central Business District.

The 200-bed IHG Wanda International Hospital in Qingdao will be located within the Qingdao Oriental Movie Metropolis, a development that is currently under construction and is scheduled to open in August 2018. The properties will be developed under the highest international design and construction standards, and IHG will ensure the hospitals obtain Joint Commission on Accreditation of Healthcare Organizations (JCI; Oakbrook terrace, IL, USA; www. jointcommission.org) or equivalent international accreditations. “Wanda is a beloved company in China. By partnering with Wanda, IHG will be able to bring its expertise into the booming Chinese healthcare market,” said Chester King, Asia Chairman of IHG. “The collaboration between Wanda and IHG will continue to contribute to commercial relations between China and the UK.” “Bringing a top level international

hospital brand to the Chinese market is a new innovation in China,” said Wang Jianlin, Chairman of Wanda Group. “It not only satisfies the growing healthcare needs of the country’s affluent population, but also helps the cities in which these projects are located to elevate their healthcare standards to international levels, and to serve as role models for the development of premium healthcare in China.” Wanda Group is China’s biggest private property developer and the world’s largest cinema chain operator, owning Wanda Cinemas, AMC

Entertainment, and the Hoyts Group. The company operates in four major industries – commercial property, luxury hotels, culture and tourism, and department stores. Founded in 1978, IHG has completed over 450 healthcare projects in over 50 countries for private and public sector clients, including 22 national governments, the United Nations, the World Bank, and the International Finance Corporation. Image: The Wanda Group and IHG at a signing ceremony (Photo courtesy of the Wanda Group).

HospiMedica International May-June/2016

Industry News

Elekta in Strategic Partnership with Australian Radiotherapy Provider lekta (Stockholm, Sweden; www.elekta.com), a company pioneering cancer and brain disorders treatment solutions, has announced a multiyear strategic partnership with GenesisCare (Alexandria, NSW, Australia; www.genesis care.com.au), the largest radiotherapy provider in Australia. The eight-year partnership is valued at more than USD 100 million and includes Elekta's Leksell Gamma Knife radiosurgery system, brachytherapy systems, Versa HD linear accelerators, software, and services for use in GenesisCare cancer treatment centers in Australia, the UK, and in new markets. The agreement also includes Elekta’s MOSAIQ enterprise licensing system, and the METRIQ software. The MOSAIQ software enables a com-

pletely optimized and automated workflow across a global enterprise, while the METRIQ software is an integrated cancer registry, including reporting, and follow-up analysis. Dan Collins, managing director of GenesisCare, said, "Elekta is a natural partner for GenesisCare. We want all cancer patients to receive rapid access to high quality care. Elekta helps us make this happen with their suite of technology solutions, global reach and commitment to innovation. The MR-linac is a game changer. We expect cancer patients, including those receiving treatment for prostate, breast and other cancers, to benefit from this innovation. Anything that improves the accuracy of treatment and provides a smoother patient experience should improve outcomes."

Cloud-Based Solutions Provider Adds Image Sharing Capabilities edidata (New York, NY, USA; www.mdsol.com), a leading global cloud-based solutions provider for clinical research has acquired Intelemage (Cincinnati, OH, USA; www. intelemage.com) a global medical image sharing and workflow management company. Medical imaging data is the fastest growing and largest source of data in the healthcare industry and cloud storage provides users with an endto-end solution for capturing, managing, and analyzing their medical imaging data.

Under the transaction Medidata will integrate Intelemage technology into the Medidata Clinical Cloud, a Software as a Service (SaaS) platform. Intelemage operates in 85 countries, and in more than 5,000 locations around the world, and provides tools for capturing medical imaging data, workflow management. The tools are used in clinical trials, hospitals, life sciences companies, research institutions, doctors, and core labs. The tools provide a single environment for managing all imaging activities, a high level of data control and access, and performance metrics.

Consolidation in Ultrasound Transducer Disinfection Field he market leader for highlevel ultrasound transducer disinfection products has been acquired by a leading manufacturer of ultrasound guidance devices and infection control products. The acquisition will consolidate a range of hardware, and consumable products for a growing market in cost-effective infection control products, and ultrasound transducer reprocessing. PCI Medical (www.pcimedical. com) was acquired by CIVCO Medical Solutions (www.civco.com) and will enable CIVCO to add storage and high-level disinfection and reprocessing of ultrasound transducers to

HospiMedica International May-June/2016

their portfolio. PCI Medical is a leader in the market for Joint Commission and US Food and Drug Administration (FDA; Silver Spring, MD USA; www.fda.gov)-compliant infection control products for ultrasound transducer disinfection, and storage devices. CIVCO Medical Solutions' Multi-Modality Imaging (MMI) unit designs and manufactures accessories for diagnostic and therapeutic imaging, and interventional procedures, especially for the ultrasound market. CIVCO's new ASTRA family of devices received FDA 510(K) clearance in 2015, and enables CIVCO to enter the market for cardiology, women's and men's health products.

USA-Australian Alliance in Medical Image Management Solutions ach7 Technologies (Burlington, VT, USA; www.mach7t. com) and 3D Medical (3DM; Port Melbourne, VIC, Australia; www. 3DMedical.com.au) have formed a combined company poised to bring advanced medical image management solutions to customers worldwide. As a result, 3DM, a medical-specific three dimensional (3D) printing, holographic projection, and data integrations provider, is now a whollyowned subsidiary of Mach7 Technologies, with the combined company renamed Mach7 Technologies Limited. The merger is designed to expand the international market for the enterprise imaging and 3D printing capabilities of the company, which include 3D medical printing; EchoPixel holographic projection technology; and GestSure surgery image control. Mach7 Technologies provides an enterprise platform that delivers complete image management with rapid record identification, integration, synchronization and routing, advanced

clinical viewing, and optimized, vendor-neutral archiving. Under the terms of the merger, Mach7 Technologies will maintain its US headquarters for product development, professional services, sales and marketing, with the Australian 3DM offices in charge of expanding sales and marketing efforts throughout Australia, New Zealand, and Western Europe. “We will remain a nimble company focused on providing the most innovative enterprise imaging platform in the world. Access to new capital will enable us to surpass business and product roadmap goals in a shorter time frame and to better serve our customers,” said Albert Liong, CEO of Mach7 Technologies Limited. “Mach7 has enjoyed substantial growth in recent years, and we feel this will be enhanced with access to the public capital market. Australian investors appreciate world leading healthcare technology, and we look forward to this new phase as we continue to build our global presence.”

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World Congress of Cardiology & Cardiovascular Health 2016. Jun 4-7; Mexico City, Mexico; Web: www.world-heart-federation. org Africa Health 2016. Jun 8-10; Johannesburg, Gauteng; Web: www.africahealthexhibition.com CARDIOSTIM 2016 - World Congress in Cardiac Electrophysiology. Jun 8-11; Nice, France; Web: www.cardiostim. com ISURA 2016 - International Symposium of Ultrasound for Regional Anaesthesia. Jun 1114; Toronto, Canada; Web: www.wfsahq.org 24th International Congress of the EAES - European Association for Endoscopic Surgery and Other Interventional Techniques. Jun 15-18; Amsterdam, The Netherlands; Web: www. eaes-eur.org/home.aspx

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SEPTEMBER 2016 ERS 2016 – Annual Congress of European Respiratory Society. Sep 3-7; London, UK; Web: www.erscongress.org 35th Annual ESRA Congress 2016- The European Society of Rergional Anaethesia and Pain Therapy. Sep 7-10; Maastricht, The Netherlands; Web: http://esraeurope.org/meetings EACMFS 2016- European Association for Cranio Maxillofacial Surgery Congress. Sep 13-16; London, United Kingdom; Web: www.2016.eacmfscongress.org 26th World Congress on Ultrasound in Obstetrics and Gynecology. Sep 25-28; Rome, Italy; Web: www.isuog.org

OCTOBER 2016 ESICM 2016 – 29th Annual Congress – European Society of Intensive Care Medicine. Oct 1-5; Milan, Italy; Web: www. esicm.org 11th Interventional MRI Symposium. Oct 7-8; Baltimore, USA; Web: www.HopkinsCME.edu 24th UEG Week – United European Gastroenterology. Oct 15V

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