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Vol.33 No.8 • 12/2015-1/2016

LEADER DAILY CLINICAL NEWS

ISSN 0898-7270

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Early Warning Software Forecasts Deadly Sepsis new study describes how a computer algorithm can be used to predict which patients will develop septic shock. Researchers at Johns Hopkins University (JHU; Baltimore, MD, USA; www.jhu.edu) developed the targeted real-time early warning score (TREWScore) for the detection of potential future septic shock based

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n innovative Ultraviolet C band (UV-C) cleaning device can kill 31 pathogens, including C. difficile and methicillin-resistant staphylococcus aureus (MRSA) in just five minutes.

The Optimum-UV Enlight system can induce a 4-log reduction of C. difficile spores, and a greater than 5-log reduction of other pathogens such as

MRSA, vancomycin-resistant Enterococci (VRE) and carbapenem-resistant Enterobacteriaceae (CRE), when operated at a distance of up to two meters. The system is designed to supplement manual disinfection using bleach germicides or hydrogen peroxide (H2O2) products. The combined manual surface disinfection

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Image: Courtesy of Fraunhofer IPM

Rapid Automated System Analyzes Kidney Stones A n innovative system rapidly analyzes urinary stones after a surgical procedure, thus determining appropriate postoperative care without resort to drying and pulverizing the stones prior to analysis.

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novel noninvasive brain monitor uses radio waves to detect changes in the flow of intracranial fluids. The Cerebrotech Intracranial Fluids Monitor (ICP) is a real-time volumetric integral phase shift (VIPS) spectroscopy monitor that consists of a headband with multiple integrated antennas that broadcast and receive each other’s signals; the frequency response of the phase angle between a transmitter and receiver antenna

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Ablation Device Treats Heavy Menstrual Bleeding new endometrial ablation system treats menorrhagia in premenopausal women due to benign causes, and for whom childbearing is complete. The Minerva surgical endometrial ablation system uses three separate ablation mechanisms to provide a safer and more effective means of treating excessive menstrual bleeding. The system is based on an impedance controlled treatment cycle specific to individual patient conditions.

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Image: A kidney stone being analyzed automatically using Raman spectrosopy

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Brain Scanning Headband Detects Traumatic Injuries

Innovative UV Device Fights Drug-Resistant Bacteria

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Guidelines for Sharing Individual Medical Data in Developing Countries

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novel ventilation solution uses surface electromyography (sEMG) measurements from respiratory muscles to boost patient breathing synchronization. The Dipha system is a light weight, smartphone sized, battery powered, 16-channel amplifier that is used to derive very accurate measurements of the EMG activity of the diaphragm and auxiliary respiration muscles.

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EMG Technology Enhances Mechanical Ventilation

special issue of the Journal of Empirical Research on Human Research Ethics (JERHRE) presents guidelines, protocols, models, and new resources to improve data sharing across the globe.

The new issue outlines the views of researchers and gatekeepers of biomedical research in five developing

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countries – India, Kenya, South Africa, Thailand, and Vietnam – on the possibility of expanding the sharing of their individual-level biomedical research data, with a focus on ethical implications of sharing health research data in these low and middle income settings.

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Ablation Device Treats Heavy Menstrual Bleeding cont’d from cover

The first ablation step uses bipolar radiofrequency (RF) energy to ablate the endometrium. The second step uses the high voltage RF electrical current to ionize fully contained and circulated argon gas within a plasma formation array (PFA) sealed silicone membrane.

When the stretchable silicone membrane is deployed it conforms to the uterus; once energized, the argon gas is ionized, turning it in to a stream of plasma, which heats the interior surface of the silicone membrane. The thermal energy is then conducted uniformly to the tissue in contact with the membrane. In the third step, released intracavitary fluids fills the gaps missed in the first two steps and further ablate remaining endometrial tissue. The system integration results in a faster procedure time and improved tissue contact.

Other features of the system include easy insertion, seating, and a non-stick atraumatic removal due to the lubricous nature of the silicone membrane array; a patented uterine integrity test (UIT) that automatically checks the integrity of the uterine cavity including the array membrane; and a cervical sealing balloon that positively seals the cervix canal near the internal os.

The Endometrial Ablation System is a product of Minerva Surgical (Redwood City, CA,

USA; www.minervasurgical.com), and has been approved by the US Food and Drug Administration (FDA).

Menorrhagia, described as heavy and prolonged menstrual bleeding which disrupts a woman’s normal activities, is one of the most common complaints in gynecology. Bleeding generally lasts for more than a week, requiring women to change their pad or tampon every two hours or less. Women with menorrhagia may also pass large blood clots and experience anemia due to the volume of blood loss. Constant lower abdominal and pelvic pain, tiredness, fatigue, and shortness of breath due to the heavy bleeding are also common.

Image: The Minerva surgical endometrial ablation system (Photo courtesy of Minerva Surgical).

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Early Warning Software Forecasts Deadly Sepsis cont’d from cover

on the electronic health record (EHR) of 16,234 patients admitted to the intensive care units (ICUs) at Beth Israel Deaconess Medical Center (BIDMC; Boston, MA, USA; www.bidmc.org) between 2001 and 2007. The algorithm combines 27 different factors into a TREWScore that measures the risk of septic shock.

The TREWScore identifies patients whose data places them within an area under the receiver operating characteristic curve (AUC) of 0.83. Within that parameter, TREWScore showed specificity of 0.67 and sensitivity of 0.85, identifying patients at a median of 28.2 hours before onset, with two-thirds identified before any sepsis-related organ dysfunction. Accordingly, continuous sampling of data from the EHR and calculation of TREWScore may allow clinicians to identify patients at risk and provide earlier interventions. The study was published on August 5, 2105, in Science Translational Medicine.

“We know a lot of those deaths would likely be preventable if sepsis were diagnosed well before it develops into septic shock and organ failure,” said study coauthor Peter Pronovost, MD, PhD, vice president for patient safety and quality at JHU Medicine.

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Innovative UV Device Fights Drug-Resistant Bacteria cont’d from cover

with UV technology ensures thorough coverage, especially on areas missed during manual cleaning. A smart data reporting system tracks device usage across rooms, locations, and operators, and provides automated reporting that is accessible in real time. The system also provides diagnostic data, with automated alerts to inform users about maintenance needs and to help identify areas that require targeted staff training. An enhanced interface features data storage capabilities and a large, easy-to-use color touchscreen enables users to manage disinfection reporting analytics.

The device includes an accompanying iOS and Android apps app that allows users to remotely check on UV cycle status, as well as start or stop the device. The app uses Bluetooth technology to upload the data via a cellular/Wi-Fi link for cloud-based reporting. The system also monitors infection rates and outbreaks, allowing healthcare professionals to pinpoint problems sooner. The Optimum-UV Enlight system is a product of Clorox Healthcare (Grapevine, TX, USA; www.CloroxHealthcare.com).

“We know that environmental services and infection control professionals are looking for more efficient and easy-to-use ways to implement UV devices and track infection rates across their facilities, which can be a time-intensive process,” said Katherine Velez, of Clorox Healthcare. “The Optimum-UV Enlight System’s smart data capabilities help do the heavy lifting to improve infection control processes and minimize workflow challenges so that UV can be seamlessly integrated into larger environmental infection control practices.”

UV-C light is a UV wavelength of 254 nm that induces the formation of pyrimidine dimmers from thymine and cytosine; these dimers in turn cause disruptions in microbial DNA, making genetic replication impossible, thus destroying the organisms or rendering them unImage: The Optimum-UV Enlight able to reproduce. The efficacy of the UV-C irradiation is a function device (Photo courtesy of Clorox of many different parameters, such as intensity, exposure time, lamp Healthcare). placement, and air movement patterns.

Rapid Automated System Analyzes Kidney Stones new imaging system for rapid analysis of urinary stones immediately after the surgical procedure can help determine appropriate postoperative care. Researchers at the Fraunhofer Institute for Physical Measurement Techniques (IPM; Freiburg, Germany; www.ipm.fraunhofer.de) in collaboration with an industrial partner and University Medical Center Freiburg (Germany; www. uniklinik-freiburg.de) are developing a novel Raman spectroscopy diagnostic system for rapid and automated analysis of kidney stones. The system identifies the light spectrum of the examined sample by illuminating it with a laser, identifying the singular characteristic wave spectrum via the 1% of photons reflected back.

The researchers then use computer software to filter out the fluorescent background occurring during Raman spectroscopy. The results are then compared to a spectral database that contains data on the nine pure substances that make up 99% of urinary stones, as determined by examining nearly 160 samples; the results were confirmed by conventional infrared (IR) based analysis in a reference laboratory. Since the device employs relatively inexpensive optical components, and it can work on wet, unprepared samples, the time taken to prepare specimens is substantially reduced.

“The stones previously had to be dried and pulverized prior to analysis. Our system makes this unnecessary. Stone fragments collected during the sur-

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gical procedure do not need to be further processed. They can in principle be put directly into the Raman spectrometer for analysis,” explained IPM physician and researcher Arkadiusz Miernik, MD. “Currently there are a few specialized laboratories that can carry out this procedure using largescale analytical equipment. A compact device suitable for use in a clinical setting and allowing immediate, post interventional automated analysis is not yet available.”

“We advise stone patients to drink plenty of fluids, increase physical activities and lose weight if necessary. Unfortunately this is only a general recommendation,” added Dr. Miernik. “Once the complete system is ready for clinical use, the physician will be able to examine stone samples directly after surgical intervention on his own, thus increasing the quality of patients’ care substantially.”

Kidney stones are often no larger than a grain of rice, yet some can grow to a diameter of several centimeters, causing blockage of the ureters. If it cannot be dissolved chemically, the kidney stone is treated using extracorporeal shock-wave therapy or minimally invasive endoscopic modalities. Many of these patients suffer from disease recurrence and need retreatment, but new stone formation might be reduced by 50% if individualized follow-up care and proper measures are offered to the patient regarding dietary habits or the use of particular medication strategies, based on stone composition.

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EMG Technology Enhances Mechanical Ventilation cont’d from cover

Data acquisition and pre-processing is executed directly in the device, which is the wirelessly transmitted to a transceiver USB dongle connected to a computer. The data is then processed by dedicated advanced signal processing and analysis software in order to provide enhanced breathing synchronization with mechanical ventilation systems.

Using the sEMG data allows for virtually synchronous mechanical ventilation with the initiation of inspiration, unlike conventional ventilators, which use changes in the patients’ airflow or pressure to determine timing and the patients’ breathing pattern. Since conventional systems are dependent on these triggers to initiate ventilation, they are on average 100 ms late when compared to the patients’ natural breathing. However, since sEMG triggering is taken directly from the respiration muscles, better detection of inspiration onset is achieved, improving patient comfort.

The Dipha system is designed to be used in conjunction with the Macawi OEM respiratory module, which uses a patented blower to provide a unique combination of high performance ventilation in applications ranging from premature neonates to adults. The Dipha system and OEM respiratory module are products of Macawi (Eindhoven, The Netherlands; www.macawi.com), part of the Demcon Group (www.demcon.nl), and are intended for use in the intensive care unit (ICU), long term hospital care, and patient transport.

“In the past period we have developed the OEM respiration module containing a high-dynamic centrifugal blower, which makes it possible for a single piece of equipment to ventilate any patient, from premature babies to adults, just by changing the tubes,” said Geert van Dijk, CTO of Macawi. “Now with our sEMG technology we can continue serving the market by offering even more enhanced solutions. It is an exciting period for the market and for Macawi.”

Surface EMG assesses muscle function by recording muscle activity from the surface above the muscle (on the skin) using a pair of electrodes or a complex array of multiple electrodes to measure the potential (voltage) difference between separate electrodes. The sEMG signal derived includes information from the muscle of interest, and is therefore more representative than localized, selective needle EMG signals.

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Critical Care

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Ultrasonic Device Improves Cleaning of Medical Instruments new study describes an ultrasonic device that creates tiny bubbles that scrub medical device surfaces, thus reducing the need for additives and heating to achieve effective cleaning.

The StarStream device, developed by researchers at the University of Southampton (United Kingdom; www.southampton.ac.uk), is used to stream freeflowing water containing an electrolyte (Na2SO4) and a diluted surfactant concentration (2 mMol SDS).

The water is gently streamed through a special nozzle that causes electrolysis of the water, thus generating an electrochemical bubble swarm (EBS) of tiny bubbles of hydrogen and oxygen, which dramatically improve the cleaning power of the water. The surfactant is employed to maintain the average size of the bubbles to 100- m diameter within the swarm.

The EBS also perturbs an acoustic ultrasonic trans-

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mission through the stream, which in order to optimize the cleaning process is pulsed and synchronized with electrochemical current, but with different duty cycles. The cleaning action was shown on structured surfaces loaded with fluorescent particles, demonstrating significantly enhanced cleaning compared to that found with an inherent bubble population produced by the flow and acoustic regime alone, under the same conditions. The study describing the StarStream device was published on August 12, 2015, in Physical Chemistry Chemical Physics.

“In the absence of sufficient cleaning of medical instruments, contamination and infection can result in serious consequences for the health sector and remains a significant challenge,” said lead author Prof.

Tim Leighton, PhD, of the Institute of Sound and Vibration Research.

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The device is also cost-effective; it can save an estimated 79%–97% of the energy used in current commercial products and also recycles water, thus savings 83%–99% of the water used. It is now being commercialized by Ultrawave (South Glamorgan, United Kingdom; www.ultrawave.co.uk).

Image: The StarStream ultrasonic cleaning device (Photo courtesy of Ultrawave).

Guidelines for Sharing Individual Medical Data in Developing Countries cont’d from cover

the majority of researchers questioned were wary of sharing individual-level health research data due to very limited experience of sharing with secondary researchers. Reasons for resistance and skepticism about sharing data were varied; among researchers in Mumbai (India), concerns for data sharing were centered on three themes: acknowledgment of data producers, skepticism about the process of sharing, and the fact that the terrain of data sharing was essentially uncharted and confusing. In Vietnam, it was recognized that there is a need to ensure that the rights and interests of participants, communities, and primary researchers are respected through transparent and accountable data-sharing processes.

In Kenya, trust-building practices such as prior awareness and consent were deemed crucial to promoting data sharing. In Thailand, data sharing was generally seen as something positive, a means to contribute to scientific progress, to higher-quality analysis, better use of resources, greater accountability, and more outputs.

And within South Africa’s public research sector, commitment to share data was evident, despite the absence of national guidance and regulation, but disparate views emerged among researchers about the possible harms and benefits of data sharing.

“Gatekeepers of data in these studies, although positive about the general concept, were skeptical about sharing their own data, not unlike the responses of persons in Western countries who have not shared data,” wrote Joan E. Sieber, editor-in-chief of JERHRE. “The political, scientific, and economic problems of understanding and stopping new diseases will be vastly reduced when an infrastructure and baseline data are readily available to scientists. Each discipline raises its own set of challenges, risks, and benefits of data sharing, but with ingenuity, the risks can be overcome.”

In an effort to support data sharing, the study authors developed an open access online resource, including a free online course, focusing on ethics and best practices in sharing individual-level data in low and middle-income settings.

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Easy-to-Use Portable Device Quickly Measures Vital Signs esearchers have developed a 3-D-printed, novel hand-held device with sensors that quickly test a patient’s blood pressure, blood oxygen, breathing rate, heart rate, and heartbeat pattern. Updated versions of the prototype could replace hospital vital sign monitors and could gather more data than is typically collected during medical assessment in an ambulance, emergency room, doctor’s office, or patient’s home.

Vital sign monitors in hospitals are relatively bulky, have restrictive mobility, and capture limited information. Engineers and physicians at Johns Hopkins University School of Medicine (Baltimore, MD, USA; www.hopkinsmedicine.org) have developed the “MouthLab” hand-held device to quickly pick up vital signs from a patient’s lips and fingertip using mouthpiece and thumb pad sensors. The device could help avoid unnecessary ambulance trips and emergency room visits when vital signs are good, and may help detect early signs of medical emergencies, such as heart attacks.

In a new study testing vital signs from 52 volunteers, MouthLab compared well with measurements from standard hospital monitors. The device also takes a basic electrocardiogram (ECG). “We see it as a ‘check-engine’ light for humans,” said first author and lead engineer, Gene Fridman, PhD, assistant professor at Johns Hopkins, “It can be used by people without special training, at home or in the field.” Prof. Fridman is also founder and owner of startup Multisensor Diagnostics, LLC, to which MouthLab technology has been optioned by Johns Hopkins University.

MouthLab consists of a small, flexible mouthpiece (like those used by scuba divers) connected to the hand-held unit. The mouthpiece contains a temperature sensor and blood-volume sensor. The thumb pad on the hand-held unit has a miniaturized pulse oximeter – a smaller version of the finger-gripping device used in hospitals, which uses beams of light to measure blood oxygen levels.

Other sensors measure breathing from the nose and mouth.

MouthLab also has three electrodes for ECGs – one on the thumb pad, one on the mouthpiece upper lip and one on the lower lip – that work about as well

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as the chest and ankle electrodes used on basic ECG equipment in many ambulances or clinics.

The ECG signal is the basis for MouthLab’s innovative method for recording blood pressure. When the signal shows the heart is contracting, the device optically measures changes in volume of blood reaching the thumb and upper lip.

Unique software converts the blood flow data into systolic and diastolic pressure readings. The study found that MouthLab blood pressure readings effectively match those taken with standard, arm-squeezing cuffs.

The study, by Fridman GY, et al., was published in the September 2015 issue of the journal Annals of Biomedical Engineering.

Image: A prototype of the Mouth Lab portable device that quickly picks up and reports patient vital signs (Photo courtesy of Yuankui Zhu / Johns Hopkins Medicine).

Brain Scanning Headband Detects Traumatic Injuries cont’d from cover

represents changes in the electrical properties of tissue resulting from small changes in intracranial fluid flow. A computer algorithm analyzes the changes in the tissue electrical properties, providing a visual readout on a real-time monitor.

The device detects characteristic changes in tissue composition and structure in traumatic brain injury (TBI). Thus, for brain edemas, swelling results from an increase in fluid in the tissue. For brain hematomas, internal bleeding causes blood buildup in certain regions of the brain. In the frequency range of 153–166 MHz, the device can distinguish between brain edema and a hematoma by the changes in electromagnetic tissue properties. The Cerebrotech ICP is a product of Cerebrotech (Pleasanton, CA, USA; www.cerebrotechmedical.com), and has received the European Community CE marking of approval.

“It has been remarkable to watch this powerful technology unfold, and to see it realizing the potential that we were only imagining just a few years

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ago,” said Wade Smith, PhD, MD, director of neurovascular services at UCSF medical center (San Francisco, CA, USA), and chairman of the Cerebrotech scientific advisory board.

“Cerebrotech’s monitor can give us valuable insight into the progression of edema and bleeding in our patients, and help us manage their care as they recover from stroke and brain trauma.”

“This technology is inexpensive, it can be used in economically disadvantaged parts of the world and in rural areas that lack industrial infrastructure, and it may substantially reduce the cost and change the paradigm of medical diagnostics,” said Prof, Cesar Gonzalez, MD, of Instituto Politécnico Nacional (NPI; Mexico City, Mexico; www.ipn.mx), who developed the technology.

“This suggests the potential for the device to be used as an indication for the health of the brain in older patients in a similar way in which measurements of blood pressure, ECG, cholesterol or other health markers are used for diagnostic of human health conditions.”

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Trained Medical Interpreters Can Reduce Treatment Errors rrors in medical interpretation are common for patients with limited English proficiency (LEP), especially when the interpreter is a family member, claims a new study.

Researchers at the University of California, San Francisco (UCSF; USA; www.ucsf.edu) conducted a cross-sectional study of transcribed audiotaped primary care visits that included 32 Spanish-speaking Latino patients and 14 clinicians. The transcripts were coded professionally for accurate and inaccurate interpretation text unit (TU) instances. Two internists then reviewed the transcripts and independently verified inaccurate TU instances, and rated their clinical significance as clinically insignificant, mildly, moderately, or

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highly clinically significant.

The results showed that accurate interpretation made up 70% of total coded TU’s and inaccurate interpretation made up 30%. Inaccurate interpretation occurred at twice the rate for ad hoc (54%) versus in-person professional (25%) and professional videoconferencing (23%) interpretation, due to more errors of omission and answers for patient or clinician.

The mean number of errors per visit was 27, with 7.1% of errors rated as moderately/highly clinically significant. The study was published in the October 2015 issue of Medical Care.

“Inaccurate language interpretation in medical encounters is common and more frequent when untrained interpreters are used, compared with professional in-person or

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videoconferencing, which may increase access to higher quality medical interpretation services,” concluded lead author Eliseo J. Pérez-Stable, MD, and colleagues. “Full deployment of professional interpretation capacity for LEP patients is a quality of care issue whose time has come.”

Medical interpreters provide language services to LEP patients, acting as conduits between them and medical professionals by orally translating information into a patient’s native

language in layman’s terms. The medical interpreter then translates the patient’s response back to the professional, using proper medical terminology to explain reasons for the medical visit and past medical and family history. At the same time they explain medical and surgical procedures, medical care instructions, provide drug information, and help schedule follow-up appointments.

Troponin Blood Test May Minimize Hospitalization new study shows that using a high-sensitivity cardiac troponin I (cTnI) assay can halve the number of people admitted to hospital with a suspected myocardial infarction (MI).

Researchers at the University of Edinburgh (United Kingdom; www. ed.ac.uk), Hennepin County Medical Center (Minneapolis, MN, USA; www.hcmc.org), and other institutions conducted a prospective cohort study of 6,304 patients with suspected acute coronary syndrome presenting to four secondary and tertiary care hospitals in Scotland. The researchers measured plasma cTnI concentrations at presentation and evaluated the negative predictive value of a range of troponin concentrations for MI, subsequent MI, or cardiac death at 30 days.

The results showed that low plasma cTnI concentrations could identify two-thirds of patients at very low risk of cardiac events who could be discharged from hospital. In patients without MI at presentation, troponin

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concentrations were less than 5 ng/L in 61% of the patients, with a negative predictive value of 99.6% consistent across groups stratified by age, sex, risk factors, and previous cardiovascular disease. At one year, these patients had a lower risk of MI and cardiac death than did those with a cTnI concentration of 5 ng/L or more. The study was published on October 7, 2015, in the Lancet.

Cardiac troponin T (cTnT) and troponin I (cTnI) are regulatory proteins that control the calcium mediated interaction between actin and myosin. The cardiac forms of these regulatory proteins are coded by specific genes and theoretically have the potential of being unique to the myocardium. The measurement of serum cTnI and cTnT is superior in terms of sensitivity and specificity to cardiac muscle enzyme measurements in the identification of cardiac muscle damage, currently accepted as the standard biochemical marker for the diagnosis of MI. HospiMedica International December/2015-January/2016

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Pneumatic Compression Reduces Lymphedema Consequences ymphedema patients saw a nearly 80% reduction in their cellulitis episodes by using an advanced pneumatic compression device (APCD) at home, according to a new study. Researchers at Vanderbilt University (Nashville, TN, USA; www.vanderbilt.edu) and the University of Minnesota (UMN; Minneapolis, USA; www.umn.edu) conducted a retrospective analysis involving 718 patients (both with and without cancer) to examine the impact of an APCD on cutaneous and other clinical outcomes, as well as health economic costs. The researchers compared outcomes for the year before and after APCD purchase, with the main outcomes and measures including rates of cellulitis, use of lymphedema-related manual therapy, and outpatient and inpatient hospitalizations.

The results showed that APCD use was associated with reduction in cellulitis episodes, lymphedema-related manual therapy, and outpatient visits. Among the cancer cohort, total lymphedema-related costs per patient were reduced by 37% (from USD 2,597 to USD 1,642). Reductions in physical therapy and outpatient visits resulted in a 37% decrease in lymphedema-related costs per patient, excluding medical equipment, among those with cancer, and a 36% decrease in costs for the noncancer cohort. The study was published on October 7, 2015, in JAMA Dermatology.

“This could be a game-changer in the area of lymphedema care. Up to 10 million people in the United States are living and oftentimes suffering with symptoms of lymphedema,” said study co-lead author Prof.

Sheila Ridner, PhD, of Vanderbilt University School of Nursing. “The idea that a home advanced pneumatic compression device can provide relief, decrease the number of cellulitis episodes, and save money is an important new option for patients.”

“Patients with lymphedema turn to dermatologists, primary care, and vascular physicians for treatment, and now these providers have a therapy to improve skin, limb, and systemic health for these individuals,” said Jerry Mattys, CEO of Tactile Medical (Minneapolis, MN, USA; www. tactilemedical.com), which developed the Flexitouch APCD system used in the study.

“This device sequentially inflates over areas of the body affected by lymphedema to facilitate the movement of excess fluid from the limb back to the cardiovascular system.”

Lymphedema is an accumulation of fluid in tissues commonly caused by abnormalities in the lymphatic system or removal or damage to a person’s lymph nodes. Symptoms include swelling, recurrent cellulitis, loss of physical function, psychological stress and diminished quality of life. Lymphedema cannot be cured and is typically managed through combined therapies of manual lymph drainage, multilayer bandaging, decongestive exercise, skin care, and Visit us at long-term self-management.

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Image: The Flexitouch APCD system lymphedema pump (Photo courtesy of Tactile Medical).

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Wireless Device Modulates Drug Delivery to Brain novel wireless device as narrow as a human hair can be implanted in the brain and activated by remote control to deliver therapy.

Developed by researchers at Washington University (WUSTL; St. Louis, MO, USA; www.wustl.edu) and the and the University of Illinois (Urbana-Champaign, USA; www.illinois.edu), the implantable device is based on optogenetics, a technology that first makes individual brain cells sensitive to light, and then activates those targeted populations of cells with flashes of light. The implant is thus capable of delivering light or drugs to specific areas of the brain to treat pain, depression, epilepsy, and other neurological disorders, improving targeted drug delivery and reducing side effects.

As part of the study, which was conducted in mice, the researchers delivered a drug to just one side of an animal’s brain, stimulating neurons involved in movement, which caused the mouse to move in a cir-

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cle. In other mice, shining a light directly onto brain cells expressing a light-sensitive protein that prompted the release of dopamine, a neurotransmitter that rewarded the mice by making them feel good; the mice then returned to the same location in a maze to seek another reward. They were also able to interfere with the light-activated pursuit by remotely blocking the action of dopamine on its receptors.

The implant currently contain four chambers that carry drugs directly into the brain via microfluidic channels and microscale pumps, but it is soft (like brain tissue), and can remain in situ and function for a long time without causing inflammation or neural damage. In future, the researchers hope to include a cartridge design – much like a printer’s ink cartridge – so that drugs can continue to be delivered to specific cells in the brain or elsewhere in the body for as long as required, without the need to replace the entire device.

The study was published online on

July 16, 2015, in the journal Cell.

“In the future, it should be possible to manufacture therapeutic drugs that could be activated with light,” said co-principal investigator Michael Bruchas, PhD, an associate professor of anesthesiology and neurobiology at WUSTL. “With one of these tiny devices implanted, we could theoretically deliver a drug to a specific brain region and activate that drug with light as needed. This approach potentially could deliver therapies that are much more targeted but have fewer side effects.”

“Now, we literally can deliver

drug therapy with the press of a button. We’ve designed it to exploit infrared technology, similar to that used in a TV remote,” added study coauthor Jordan McCall, PhD. “If we want to influence an animal’s behavior with light or with a particular drug, we can simply point the remote at the animal and press a button.”

Image: Tiny, implantable devices capable of delivering light or drugs to specific areas of the brain have the potential to improve drug delivery and reduce side effects (Photo courtesy of Alex David Jerez Roman).

Google Glass Effective for Teletoxicology Consultations new study confirms that Google Glass can be used effectively for bedside emergency room (ER) toxicology consults in suspected cases of poisoning. Researchers at the University of Massachusetts Medical School (UMASS; Worcester, MA, USA; www.umass med.edu) conducted a study to examine the feasibility of using Google Glass to assess poison victims by a remote medical toxicology consult staff.

UMASS ER residents rotating on the toxicology service wore Google Glass during bedside evaluation of poisoned patients. The Glass transmitted realtime video of patients’ physical examination findings to toxicology fellows and supervisory consultants, who reviewed these findings.

The supervising consultant guided the resident through text messages displayed on the Glass. They also obtained static photos of medication bottles, electrocardiograms (ECGs), and other pertinent information at the discretion of the supervisor. This was done in addition to standard verbal consult available to the residents.

In all, the residents and supervisory consultants completed 18 consults through Glass, while the researchers

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evaluated the usability – i.e., quality of connectivity and video feeds – as well as attitudes towards Glass.

To safeguard patient information, each device was equipped with Pristine Eyesight, a platform which encrypted the information passing through Google Glass. The toxicologists viewing the video stream found the quality of audio and visual transmission usable in 89% of cases, and reported that their management of the patient changed after viewing the patient through Google Glass in 56% of the cases. As to treatment, based on findings obtained through Glass, the toxicologists recommended specific antidotes in six cases. The study was published in the August 2015 issue of the Journal of Medical Toxicology.

Image: Toxicology resident Dr. Peter Chai wearing Google Glass (Photo courtesy of UMASS).

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PRODUCT NEWS INFANT INCUBATOR

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DEFIBRILLATOR

PATIENT BED

MedGyn

Schiller

Sidhil

The infant incubator is designed for non-invasive measuring and graphical display of patient weight, skin temperature, SpO2, O2 saturation, humidity and room temperature. It is ideally suited for hospital care units such as NICU, special nursery units and pediatrics.

The DEFIGARD Touch7 is the first emergency monitor/defibrillator equipped with a touch screen, making it the most intuitive device available. Other features include enhanced software, a seven-inch display, lightweight design, regularly performed self-tests, and an RFID transponder.

The Innov8 iQ with split side rails is designed around optimizing tissue viability, infection control and health and safety in terms of manual handling and falls prevention. The bed is suitable for a wide range of patient groups, resulting in reduced requirements for transfer from bed to bed.

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New System Protects Healthcare Workers From Hazardous Drug Exposure novel concept in hazardous drug protection provides health care professionals with a simple design that ensures compatibility with existing work procedures.

The Halo Closed System Transfer Device (CSTD) is an airtight, leak-proof, closed system that provides complete fluid and vapor containment and a strong vial attachment. Tests have shown the system prevents escape of hazardous drug or vapor concentration, bars the transfer of environmental contaminants, and prevents microbial ingress. The easy to use system comes with few pieces and fewer steps, and is compatible with existing work procedures, protocols, and disposable equipment.

The system mechanically prohibits the transfer of environmental contaminants into the system, and the escape of drug or vapor concentrations outside the system. This is achieved by addressing safety concerns for each connection type, such as drug vial adapters, syringe and line adapters, and bag spikes, containing the drug through each of the reconstitution and transfer steps. The Halo CSTD is a product of Corvida Medical (Coralville, IA, USA; www.corvidamedical.com), and has been approved by the US Food and Drug Administration (FDA).

“We are focused on developing and introducing products designed to meet critical unmet needs, and have worked closely with thought leaders throughout our product development efforts. The feedback on Halo has been phenomenal,” said Kent Smith, President and CEO of Corvida Medical. “Health care professionals appreciate Halo’s simplicity and we look forward to introducing it to the market.”

Healthcare workers are continuously exposed to hazardous drugs during the preparation and delivery of chemotherapy, which can cause serious health problems, including cancer, infertility, genetic mutations, and other adverse effects. Protective equipment intended to shield from these dangers often can be complicated, difficult to use, and provide incomplete solutions.

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Image: The Halo Closed System Transfer Device (CSTD) (Photo courtesy of Corvida Medical).

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Discrete Trial System Helps Evaluate SCS Therapy new wireless system is designed to help chronic pain patients better assess their spinal cord stimulation (SCS) therapy prior to the permanent implant.

The Invisible Trial System evaluates SCS therapy via an entirely wireless experience based on Bluetooth wireless technology, rather than a complex physical controller. The system leverages familiar Apple (Cupertino, CA, USA; www.apple.com) technology, using the intuitive iPod touch digital device as a patient controller, while physicians utilize an iPad mini digital device to program

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and evaluate the patient’s therapy.

The iPad mini also displays trial usage data from the external pulse generator (EPG) and allows the physician to print or email the data in PDF format.

A key system features is the use of a small EPG as the system’s power source; since it uses Bluetooth to communicate between the patient’s iPod touch controller and the stimulation system, the system can be worn discreetly under a patient’s clothing. As such, the system feels essentially “invisible” to the wearer, providing a more comfortable trial experience that allows patients to fo-

Lung Simulations Could Improve Respiratory Treatment n innovative computer model that predicts the flow of liquids in human lungs could provide insight into the treatment of acute respiratory distress syndrome (ARDS).

ARDS is a life-threatening inflammation of the respiratory system that kills 74,000 adults each year in the United States alone. It is most common among patients with lung injury or sepsis, a whole-body inflammation caused by infection. Treatment involves surfactant replacement therapy (SRT) to make it easier for the lungs to inflate, similar to the therapy used in premature babies, who can lack the surfactant necessary to expand their lungs. While SRT has contributed to a dramatic reduction in mortality rates of premature babies, the attempt to implement the technology in adults has been largely unsuccessful.

To try and reveal why, researchers at the University of Michigan (U-M; Ann Arbor, USA; www.umich.edu) and Ecole Polytechnique (Palaiseau,

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France; www.polytechnique.edu) developed a mathematical computer model that provided a three-dimensional (3-D) image of exactly how SRT flowed through the lungs of patients in the three key trials that examined the technology. The first (1997) clinical study in adults showed promise, cutting mortality rate from 40% to 20%. But two larger studies in 2004 and 2011 showed no improvement in mortality, and the treatment was abandoned.

The computer model used fluid mechanical principals for 3-D modeling of the lung airway tree in both neonates and adults, showing how a liquid plug propagates through the tree from forced inspiration. In two separate modeling steps, they saw that the SRT plug deposits a coating film on the airway wall, and then splits unevenly at the bifurcation due to gravity. The model generates 3-D images of the resulting acinar distribution and calculates two global indexes, efficiency and homogeneity.

cus entirely on the system’s therapeutic impact during their trial. The Invisible Trial System is a product of St. Jude Medical (SJM; St. Paul, MN, USA; www.sjm.com), and has been approved by the US Food and Drug Administration (FDA).

“When we developed the new Invisible Trial System, we took into account physician and patient feedback that current trial systems were in some cases preventing patients from adequately assessing their therapy,” said Eric S. Fain, MD, group president of SJM. “By providing a more patientfriendly option, we think we can shorten the learning curve related to trial programming devices and allow patients to better assess the potential pain relief they’re receiving from spinal cord stimulation.”

“Patients undergoing SCS trials consistently tell us about challenges they find in navigating the SCS trial system, from programming the device, to discomfort from the programming cables, to management of both

issues,” said pain specialist Jason Pope, MD, president of Summit Pain Alliance (Santa Rosa, CA, USA). “By providing a discreet trial system, St. Jude Medical will help patients focus more on their potential pain relief and functional improvements, and less about the burdens common to traditional trial systems.”

Image: The St. Jude Medical Invisible Trial System (Photo courtesy of St. Jude Medical).

Image: A computer model of SRT delivered to an adult human lung; blue areas receive less (Photo courtesy of Prof. James Grotberg/U-M Engineering).

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PRODUCT NEWS FLAT PANEL DETECTOR

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SPECT SYSTEM

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Kubtec

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The DIGIVIEW 395 wireless flat panel detector is designed to be lightweight, durable, versatile, and easy to use. It incorporates rapid image acquisition and display, and features wireless data transmission, giving users immediate access to critical data for faster interpretation and diagnosis.

The G-SPECT enables ultra-fast and highly detailed scanning of biological processes, relevant for diagnosis and research in the human body. The high SPECT resolution of better than three millimeters is expected to enable physicians to arrive at a more accurate diagnosis.

The TE7 touch-enabled ultrasound system supports rapid and confident evaluation in multiple point-of-care (POC) settings. The intuitive tabletlike operation, superior image quality with onetouch image optimization, and exam presets improve both diagnostic confidence and efficiency.

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Alzheimer’s Linked to Specific Lifestyle Risk Factors he results of a new study have found that cardiovascular risk factors such as smoking, alcohol consumption, diabetes, and obesity, can be linked directly to smaller brain volumes in specific areas of the brain, and to lower cognitive test scores.

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The study was published online in the Radiological Society of North America (RSNA) journal Radiology and shows that the lower brain volumes may be early indicators of Alzheimer’s disease, and dementia. The study focused on specific cardiovascular risk factors and three main regions of the

brain used in memory retrieval, namely the precuneus, posterior cingulate cortex, and the hippocampus.

The researchers analyzed results from 1,629 individuals that took part in a heart study – 805 individuals under the age of 50, and 824 aged 50 years and older. The researchers looked at the participants’ initial baseline data, including laboratory and clinical tests, and data from a follow-up visit after seven years.

Obesity and smoking were linked with reduced posterior cingulate cortex volumes, while alco-

hol consumption and diabetes were linked to smaller total brain volume.

Alcohol consumption and smoking were also linked to lower hippocampal mass, and obesity, and alcohol use, and high fasting blood glucose numbers were linked to a smaller precuneus.

The researchers concluded that for participants aged 50 and less, a smaller posterior cingulate volume was a possible early risk indicator of cognitive decline, while for participants aged 50 and over, a smaller hippocampus and precuneus may be early risk indicators.

Image: Brain CT scan. A new study indicates that specific cardiovascular risk factors, such as alcohol consumption, smoking, obesity and diabetes, are associated with smaller regional brain volumes that may be early indicators of Alzheimer’s disease and dementia (Photo courtesy of Akira Ohgaki).

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Safer, More Accurate Breast Screening Technique Developed team of researchers developing a clinical prototype of a new Ultrasound Computed Tomography (UCT) breast screening technique are now ready to work with commercial partners to translate the system into a clinical device. The new screening system would cost less than currently used techniques, and provide results that are easier for clinicians to interpret. In addition the test would be safer, and more comfortable than current multistage screening techniques involving X-ray mammography, a clinical examination, further X-rays, and ultrasound.

The screening system is being developed by a team consisting of researchers from the UK National Physical Laboratory (NPL; Teddington, Middlesex, UK; www.npl.co.uk), University Hospitals Bristol (UHB; Bristol, Avon, UK; www.uhbristol.nhs.uk), North Bristol NHS Trust (NBT; Briston, Avon, UK; www.nbt.nhs.uk), Precision Acoustics (Dorchester, Dorset, UK; http://acoustics.co.uk), and Designworks.

The screening system uses a new ultrasound detection technique, developed by the NPL that uses large-area pyro-electric sensors to create an ultrasound image. These new sensors produce much fewer image artifacts than existing detectors. The procedure involves passing ultrasound waves through the breast while the breast is in a warm water bath. The ultrasound system is rotated around the breast during the exam resulting in a 3-D image of breast tissue that can be used differentiate between normal and cancerous tissue types.

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Image: The proposed ultrasound computed tomography (UCT) breast screening system (Photo courtesy of Designworks).

Women with Average-Risk for Breast Cancer Could Benefit from MRI Screening he results of a new study suggest that periodic screening of women with average risk of breast cancer, using Magnetic Resonance Imaging (MRI), improves the detection of small, highgrade breast cancers.

The study was presented in by Christiane Kuhl, MD, University of Aachen (Aachen, Germany; www.rwth-aachen.de) at the 2015 American Society of Clinical Oncology (ASCO; San Francisco, USA; www.asco.org) Breast Cancer Symposium.

In the study 2,120 women with average risk of breast cancer, were randomized, and underwent screening using breast MRI and mammography every 12, 24, or 36 months. The women in the trial had a mean age of 53.8 years, and there were 3,861 completed screening rounds. MRI screening resulted in Breast Imaging-Reporting and Data System (BI-RADS) I or II findings in 91% of the screens, BI-RADS III in 175 screens, and BI-RADs IV or V finding in 171 screens.

The study achieved an overall detection rate of 28.8 per 1,000 women, and found 61 cancers, 60 of which were detected only by MRI. The study found 20 (32.8%) DCIS cancers, 67.2% invasive cancers, 42.6% high grade, and 32.8% estrogen receptor (ER)/progesterone receptor (PR) negative cancers.

No zero interval cancers were found.

The researchers concluded that MRI screening every 3 years could be enough to establish a zero interval cancer rate, and improve detection of some cancers.

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PRODUCT NEWS MRI-COMPATIBLE REGULATORS

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The MRI-compatible regulators are tested for performance inside the bore of an MRI machine, and have proven they can be used by patients while undergoing MRI testing. They are engineered and manufactured to the highest industry tolerances, and are fully serviceable for extended life.

The FireCR Flash Reader offers crystal-clear image quality, compact size, and fast scanning speeds. The CR reader offers increased productivity with a fast throughput of up to 125 plates/hour.

The lightweight device can be placed on a counter or it can be wall-mounted.

The DX-D600 is designed to streamline imaging workflow, increase throughput and enhance the experience of patients and staff. The system combines robotization with MUSICA image processing and seamless integration with RIS and PACS to meet all DR needs.

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Portable Ultrasound Platform Features Mobile Computing and Advanced Connectivity new portable point-of-care ultrasound device, intended for use in hospitals, clinics, during patient transport, or home visits, has received the CE Marking (Conformité Européenne).

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The device is lightweight, can be controlled with one hand, and has a thumb-operated user interface. The device is integrated with a tablet that features a seven-inch high-resolution, high definition, color flow touch-

screen, WiFi, Bluetooth, USB, HDMI, and audio interface ports, and a large viewing angle within a wide dynamic range.

The iViz was designed by FUJIFILM SonoSite (Bothell, Washington, USA; www.sonosite.com), and enables the use of ultrasound even in remote locations at the point-of-care.

The iViz integrates ultrasound with medical IT (Internet Technology) resources, providing clinicians with access to learning resources, vital patient information, and online applications. The iViz integrates with the Electronic Medical Record (EMR) and other hospital IT systems allowing clinicians access to patient demographics, and cloud services for submitting reports, and sharing studies

for assessments.

The iViz supports M-Mode, Color Velocity Doppler, and high-resolution 2-D imaging, and is available with a P21v phased-array 5 MHz transducer. The iViz uses the SonoADAPT Tissue Optimization Technology, SonoHD2 Imaging Technology software.

Masayuki Higuchi, president and CEO of FUJIFILM SonoSite, said, “FUJIFILM SonoSite delivers a powerful and valuable solution to the market with the launch of iViz. It is a revolutionary tool that reaches new levels of mobility, image performance, and connectivity. Clinicians will now have access to technology that can be used on-the move, in-thefield or on-the ground.”

Image: The iViz portable ultrasound platform integrated with mobile computing and advanced connectivity (Photo courtesy of FUJIFILM SonoSite).

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Medical Imaging

Low-Dose CT Monitoring of Lung Nodules Could Spare Unnecessary Surgery new study shows that non-solid lung nodules can be safely monitored by performing annual low-dose computed tomography (CT) screening.

Non-solid nodules often show up on chest CT scans, and may result in additional imaging tests or surgery. Annual low-dose CT screening could spare patients unnecessary interventions and imaging.

The study was performed by researchers at the Icahn School of Medicine at Mount Sinai Hospital (ISMMS; New York, NY, USA; http://icahn. mssm.edu) and included 57,496 participants from the International Early Lung Cancer Program (I-ELCAP). The patients received one baseline, and repeat screenings every subsequent year, during which time the researchers evaluated any non-solid

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nodules found.

The results of the research suggest that non-solid nodules can be safely followed using annual lowdose CT screening, and can help clinicians assess a potential transition to a part-solid nodule.

Study coauthor Claudia I. Henschke, PhD, MD, Icahn School of Medicine, said, “Nonsolid nodules could be due to inflammation, infection or fibrosis, but could also be cancerous or a precursor of cancer. For screening, we have to define which nodules need further workup and how quickly we have to do that workup. The results show that if we see a nonsolid lung nodule of any size, we can tell people to come back in one year for another CT. These

findings are important for reducing unnecessary CT scans and possible biopsies or surgery in programs of CT screening for lung cancer.”

The study was published online, in the journal Radiology on July 23, 2015.

Image: A new study shows that patients who have non-solid lung nodules can be safely monitored with annual low-dose computed tomography screening (Photo courtesy of the Icahn School of Medicine at Mount Sinai Hospital).

Multiphase CT Leads to Faster and Simpler Treatment for Stroke Patients he results of a new study show that multiphase Computed Tomography (CT) angiography brain imaging could enable clinicians to treat Acute Ischemic Stroke (AIS) patients faster, and better, potentially saving lives.

The new technique can provide critical data on collaterals, improve clinical decision-making, and help clinicians predict clinical outcomes better than using current imaging techniques. The study was published online in the May 2015, issue of the journal Radiology. The study included 147 AIS patients.

All of the patients underwent scans using regular CT imaging, single-phase CT angiography, perfusion CT, and the new multiphase angiography CT technique. The various techniques were compared for their reliability, and ability to predict clinical outcomes. The patients had a mean age of 72 years. Approximately 50% of the patients were male.

Muliphase CT images the whole brain, does not require post-processing, and is less expensive than for example Magnetic Resonance Imaging (MRI), and CT perfusion. In addition the new technique requires minimal radiation, and does away with the need for additional contrast media.

The results of the study showed that multiphase CT could substantially impact the care of stroke patients, although larger studies are still needed.

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PRODUCT NEWS DRUG-ELUTING STENT

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The Synergy stent is designed to reduce the risk of complications associated with long-term polymer exposure compared with drug-eluting stents with permanent polymers that remain on the stents after the drug is delivered. It is intended for use in treating coronary artery disease.

The Airo mobile intraoperative CT offers high image quality, increases surgeon confidence, and supports advanced minimally invasive surgery.

The Airo system is considered ideal for cranial, spine and trauma procedures, and is designed to function inside existing O.R. Suites.

The CorPath 200 system is designed for performing robotic-assisted coronary angioplasties. Key features include precise robotic movement and device fixation, enhanced visualization and measurement capability, radiation protection, and an ergonomic design for reduced fatigue.

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IV Suspension System Simplifies Intra-Hospital Transport novel solution helps manage cumbersome intravenous (IV) poles, infusion pumps, or other equipment at the bedside and during intra-hospital transports.

The Medovex Streamline IV Suspension System (ISS) is a patient equipment management device that

combines the advantages of both a stand-alone and a bed-mounted IV pole into one simple system that makes the management of hospital patients and their equipment easy, safe, and efficient. With the pressing of a single pedal that automatically lifts supporting wheels off the floor,

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the ISS can go from an independent infusion stand to a suspended, securely locked part of any bed or stretcher, with all the patient’s IV infusion pumps or other equipment secured.

The patient can then be transported to any destination within the hospital by just a single person. Once at the desired location, or when eventually the patient is returned to the hospital room, the caregiver can again redeploy the wheels of the ISS to lower them to the floor while the system remains attached to the bed. Subsequently, the ISS can remain attached or be detached from the bed, providing staff with an optimal environment for nursing care of the patient.

The Medovex Streamline ISS is a product of Medovex (Atlanta, GA, USA; www.medovex.com), which acquired Streamline (Minneapolis, MN, USA), in March 2015. The company

has also recently entered into an exclusive US marketing agreement with Hill-Rom Holdings (Batesville, IN, USA; www.hill-rom.com), a leading provider of medical technologies and related services to the healthcare industry around the world. The agreement covers exclusive marketing of the ISS, which is compatible with HillRom’s full range of beds and stretchers.

“According to Critical Care Medicine, there are roughly 100,000 critical care beds in US hospitals. Streamline’s ISS technology serves a growing need for safety and efficiency for both patients and caregivers in the hospital setting,” said Jarrett Gorlin, CEO of Medovex. “The product provides caregivers with a more efficient means of handling the growing amount of patient equipment that remains with patients as they move about a hospital.”

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Image: The Streamline IV suspension system (Photo courtesy of Medovex).

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New Device Minimizes Hazards of Surgical Smoke novel evacuation device allows surgeons to provide comfortable and precise electrosurgery while minimizing the hazards of inhaling surgical smoke. The ZIP Pen smoke evacuation pencil offers surgeons three ergonomic grip options (based upon their personal preferences), to provide significantly less torque on the rear of the pencil. The first option is the Trigger grip method, wherein the ZIP Pen tubing becomes part of the hand, eliminating all torque; the second is the Over-the-Hand grip method, which reduces torque by draping the tubing over the surgeon’s thumb or back of the hand; and the third method is the Traditional grip method, in which the tubing can be kept in the full upright position to emulate a traditional pencil.

Features of the device include large activation buttons for ease of use, full 360-degree swivel capabilities for maximum procedural flexibility, and a safety grip for comfort and control. A tactile indication provides positive and instant feedback for activation and deactivation of electrosurgical energy. The ZIP Pen also features patented coated electrode technology that reduces eschar buildup during surgery. The ZIP Pen Smoke Evacuation Pencil is a product of Megadyne Medical Products (Draper, UT, USA; www.megadyne.com).

“The hazards of surgical smoke in the OR are real, and sadly, the OR staff is often exposed to more hours of surgical smoke than surgeons,” said Jill Skoczen, marketing manager at Megadyne. “By offering a highly ergonomic and efficient smoke evacuation pencil, we believe surgeons will more easily adopt this technology.”

Surgical smoke has been proven to contain 600 distinct chemical compounds, including toxins and carcinogens with mutagenic and carcinogenic potential. Studies have shown that inhaling one gram of surgical smoke contains the same toxin levels as smoking six unfiltered cigarettes.

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Image: The ZIP Pen smoke evacuation pencil (Photo courtesy of Megadyne).

Innovative Surgical Glue Hardens with Voltage biocompatible glue that hardens once an electrical current is applied to it could be used to patch internal body tissues together in just minutes.

Developed by researchers at Nanyang Technological University (NTU; Singapore; www.ntu.edu.sg) and Zhejiang University (Hangzhou, China; www. zju.edu.cn), the appropriately dubbed Voltaglue is intended for a host of wet environment applications, from making underwater repairs for ships and oil rigs easier, and up to serving as a versatile tool for surgeons. The glue is based on hydrogels consisting of carbene molecules grafted onto polyamidoamine dendrimers, which are dissolved in aqueous solvents to form viscous gels. Upon contact with electricity, the reactive carbenes cross-link the dendrimer projections.

The hardness of the glue can be adjusted through the amount of time voltage is applied, a process called electrocuring. For example, if metal panels need to be glued underwater, it has to be hard, and thus will receive prolonged electrocuring; for medical applications, the glue needs to be more pliable to avoid damage to surrounding soft tissues. Another distinct feature of the new glue is that it could be made reversible, and thus easily recycled, reused, or remanufactured into new parts and components so as to reduce waste and energy consumption. The study was published on August 18, 2015, in Nature Communications.

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3-D Printed Ribcage Promotes Sternocostal Reconstruction new study describes how a custom-made three-dimensional (3-D) titanium-printed prosthesis was used to reconstruct a chest wall.

The procedure performed by surgeons at Salamanca University Hospital (Spain; www.usal.es) was undertaken in a 54-year-old Spanish male diagnosed with a chest wall sarcoma. After the surgical team made the decision to remove the sternum and a portion of the rib cage, they searched for a sternal reconstruction implant that would not only guarantee preservation of respiratory mechanics, but also provide adequate mediastinal protection and acceptable cosmetic results. To do so, they approached Anatomics (Melbourne, Australia; www.anatomics.com).

Using high-resolution computerized tomography (CT) data, Anatomics was able to create a 3-D reconstruction of the chest wall and tumor, allowing the surgeons to plan and accurately define resection margins. They then manufactured the reconstruction implant out of surgical grade titanium alloy using laser sintering printing techniques at the Aus-

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tralian Commonwealth Scientific and Industrial Research Organization (CSIRO, Melbourne, Australia; www.csiro.au) 3D printing facility, known as Lab 22.

The 3-D printed implant that was fabricated consists of a rigid sternal core and semi-flexible titanium rods that act as prosthetic ribs attached to the sternum. During the resection, the surgeons used an intraoperative template to set resection margins so that the implant could be precisely placed. They also used a new and safer rib fixation system to connect the implant to the remaining sections of the ribcage. The design methodology and surgical procedure were described in a study published on August 4, 2015, in the European Journal of Cardio-Thoracic Surgery.

“We thought maybe we could create a new type of implant that we could fully customize to replicate the intricate structures of the sternum and ribs. We wanted to provide a safer option for our patient, and improve their recovery post-surgery,” said lead surgeon José Aranda, MD. “The operation was very successful; thanks to 3-D

printing technology and a unique resection template, we were able to create a body part that was fully customized and fitted like a glove.”

“We wanted to 3-D print the implant from titanium because of its complex geometry and design. While titanium implants have previously been used in chest surgery, designs have not considered the issues surrounding long term fixation,” said Andrew Batty, CEO of Anatomics. “Flat and plate implants rely on screws for rigid fixation that may come loose over time. This can increase the risk of complications and the possibility of reoperation.”

“We built the implant using our AUD 1.3 million Arcam printer. The

printer works by directing an electron beam at a bed of titanium powder in order to melt it. This process is then repeated, building the product up layerby-layer until you have a complete implant,” concluded Alex Kingsbury, of the CSIRO manufacturing team. “3D printing has significant advantages over traditional manufacturing methods, particularly for biomedical applications. As well as being customizable, it also allows for rapid prototyping, which can make a big difference if a patient is waiting for surgery.”

Image: The 3-D printed titanium sternum and ribs (Photo courtesy of CSIRO).

Nanotube Fibers Could Restore Electrical Health to Hearts oft, flexible nanotube fibers could be used to bridge scar tissue and restore electrical conductivity to damaged heart tissue, according to a new study.

Developed by researchers at Rice University (Rice, Houston, TX, USA; www.rice.edu) and the Texas Heart Institute (Houston, TX, USA; www. texasheart.org), the fibers are miniscule, about a quarter of the thickness of a human hair, but still contain millions of microscopic nanotubes made of pure carbon. Since the fibers are soft, flexible, and extremely tough, the researchers claim they should be far more suitable to fulfill the biological requisites needed to deliver electrical power to devices such as pacemakers.

The nanotube fibers exhibit low impedance, which allows electricity to move from tissue across the scartissue bridge and back with ease, far better than with the metal leads currently used. According to the researchers, the fibers have potential for many other applications, including helping patients with Parkinson’s disease (PD) who require brain implants to treat their neurological conditions. The researchers are continu-

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ing to test the fiber’s biocompatibility, and expect that human trials are just a few years away.

“Though the fibers were developed to replace the miles of cables in commercial airplanes to save weight, their potential for medical applications became quickly apparent,” said chemist and chemical engineer Matteo Pasquali, PhD, of Rice University.

“We didn’t design the fiber to be soft, but it turns out to be mechanically very similar to a suture, and it has all the electrical function necessary for an application like this.”

Image: A spool of pure carbon nanotube fiber (Photo courtesy of Jeff Witlow / Rice University).

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Surgical Techniques

Pregnancy Complications Raise Heart Disease Risk new study suggests a high correlation between women who experienced complications during pregnancy and those facing death from heart disease later in life. Researchers at the Public Health Institute (PHI; Oakland, CA, USA; Berkeley, CA; www.phi.org) conducted a study involving 14,062 women, examining pregnancy events over five decades (1959–1967) and CVD death through 2011 in order to identify the combination of pregnancy

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complications that predict risk for cardiovascular disease (CVD) death, and how these risk changes with age.

CVD death was determined by linkage to California Vital Statistics and to the US National Death Index. The women were a median age of 26 years at enrollment and 66 years old in 2011.

The results showed that delivery of a small-for-gestation or preterm infant and early-onset preeclampsia (by week 34) significantly predicted

Mosquito Mesh Could Help Raise Herniorrhaphy Rates new doctoral thesis suggests that inexpensive mosquito mesh could be used as a safe alternative for groin hernia surgery in lower income countries.

A collaboration of researchers at Umea University (Sweden; www. umu.se), Karolinska Institutet (KI, Solna, Sweden; www.ki.se), and Makerere University (Kampala, Uganda; mak.ac.ug) conducted three studies in the Iganga and Mayuge districts of eastern Uganda in order to define the prevalence of groin hernia; relate it to the surgical capacity, outcomes, and costs of surgery; and investigate the feasibility and difference in cost and cost-effectiveness of replacing a commercial mesh with a

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mosquito mesh in groin hernia surgery via a double blinded, randomized controlled trial.

The results showed that the prevalence of untreated groin hernia among the study participants was 6.6%, and that that the rate of groin hernia surgery was 17 per 100,000 of the general population, meaning that less than 1% of the estimated number of groin hernia sufferers is operated on per year. The third study found no significant differences in recurrence rates, postoperative and chronic complications, and patient satisfaction among the 300 patients operated using the mosquito mesh, compared to commercial mesh.

premature CVD death. Preterm birth combined with hemorrhage, gestational hypertension, or pre-existing hypertension identified women with a 4- to 7-fold increased risk of CVD death. And preeclampsia in combination with pre-existing hypertension conferred a significant 6-fold risk, compared to a 4-fold risk for pre-existing hypertension alone.

The study also established two new conditions that could indicate future heart disease: glycosuria, or high levels of sugar in urine, entailed a 4.2-times greater risk, while hemoglobin decline over the second and third trimesters increased CVD risk of 1.7 times. Overall, 6%–8% of women developed gestational hyper-

tension; 5%–8% of women developed preeclampsia; and 2%–5% of the women developed gestational diabetes. The study was published on September 21, 2015, in Circulation.

“We observed combinations of pregnancy complications that predict high risk of death and two new risk markers, glycosuria and hemoglobin decline,” concluded study authors Piera Cirillo, MPH, and Barbara Cohn, PhD, of the PHI Child Health and Development Studies (CHDS) unit. “Obstetricians serve as primary care physicians for many young women and can readily use these complications to identify high-risk women to implement early prevention.”

Endocarditis Postsurgical Risk Higher in Drug Addicts njection drug users who undergo surgery for infective endocarditis (IE) have a 10 times higher risk of reoperation or death following surgery compared to those who do not, according to a new study.

Researchers at the Cleveland Clinic (CC; OH, USA; my.clevelandclinic. org) conducted a study to evaluate the effect of active ongoing injection drug use (IDU) on outcomes after operation for IE. Of the 536 IE patients identified from the CC Infective Endocarditis and Cardiovascular Information registries surgically treated at the CC during the five-year study period, 41 (8%) were actively injected drugs. The primary outcome of the study was death or reoperation for IE. The results showed that patients who injected drugs had poorer survival free of reoperation, with the risk of events varied with time; 90–180 days after surgery, injection drug abusers had 10 times the risk of death or reoperation for IE than the

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patients who did not inject drugs. Before or after that time, all patients appeared to have similar risk for death or reoperation. They also found that while in IDU-patients reoperation and death contributed equally to outcome, reoperation for IE was far less common among those that did not abuse drugs. The study was published in the September 2015 issue of the Annals of Thoracic Surgery.

IE is defined as an infection of the endocardial surface of the heart, which may include one or more heart valves, the mural endocardium, or a septal defect. Intracardiac effects include severe valvular insufficiency, which may lead to intractable congestive heart failure (CHF) and myocardial abscesses. Historically, the main risk factor for IE was rheumatic heart disease, but recent research has shown that other risk factors have gained prominence, such as IDU, prosthetic valve infection, degenerative valvular disease, and hemodialysis.

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PRODUCT NEWS SPINAL TRUSS SYSTEM

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SPINAL FUSION SYSTEM

CORONARY GUIDE WIRE

4WEB Medical

Benvenue Medical

Biotronik

The Posterior Spine Truss system encompasses 150 implants and affords surgeons a range of options for patient anatomy. The implants provide functionality such as a biconvex web structure that distributes the load over a larger surface area at the endplate interface to minimize subsidence.

The Luna 3D system is designed to provide the least minimally invasive approach to lumbar spinal fusion, while providing spine surgeons control and flexibility in implantation. Features include a small profile PEEK implant designed to expand in three dimensions within the disc space.

The Galeo guide wire enhances tactile feel, granting a better sense of what is happening inside the vessel. The torque response also improves steerability through complex anatomies, making it easier to control the guide wire during the procedure, improving the chances for an optimal outcome.

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Annuloplasty System Promotes Mitral Valve Repair n implantable mitral reconstruction device proves a highly effective treatment option for reducing functional mitral regurgitation (MR).

The Cardioband mitral reconstruc-

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tion system combines a reconstruction implant that is connected to the mitral annulus using specially designed anchors, and a transfemoral, transseptal delivery system. The mitral annulus is reshaped under

echocardiographic guidance for realtime adjustment on the beating heart, thus delivering optimal MR reduction results. The transcatheter, supra-annular approach does not interfere with the mitral valve leaflets or chordae, and does not preclude subsequent treatment options if they become necessary.

In a multicenter feasibility trial that included more than 50 patients, Cardioband was shown to significantly reduce annular size, with significant improvement in MR. After six months of follow-up, 82% of the patients were categorized in NYHA Class I-II, with significant improvement of Minnesota quality of life and six-minute walk test scores. The Cardioband mitral reconstruction system is a product of Valtech Cardio (Or Yehuda, Israel; www. valtechcardio.com), and has received the CE marking of approval.

“Receipt of the CE Mark is the culmination of concerted and concentrated efforts by many individuals, and it is the result of productive collaboration with the medical community,” said Amir Gross, founder and CEO of Valtech. “We are confident that CarLINKXPRESS COM

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dioband will prove to be a meaningful addition to physician’s available treatment options in addressing MR, providing a first-line mitral valve repair option that preserves the ability to perform future percutaneous or surgical valve repair and replacement.”

“The future of functional mitral regurgitation treatment lies in the repair-and-replace paradigm,” said Francesco Maisano, MD, first user of the Cardioband procedure and chairman and a professor of cardiovascular surgery at The University Hospital of Zurich (Switzerland).

FMR is considered a disease of the left ventricle, not of the mitral valve, occurring when the left ventricle of the heart is distorted or enlarged, thus displacing the papillary muscles that support the two valve leaflets and stretching the annulus. Since the valve leaflets can no longer come together to close the annulus, blood flows back into the atrium. If left untreated, FMR overloads the heart and can lead to or accelerate heart failure.

Image: The Cardioband mitral reconstruction system (Photo courtesy of Valtech Cardio).

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Surgical Techniques

Elastic Sealant Protects Suture Line After Gastro Surgery novel synthetic sealant has been specifically designed to help reduce leaks after gastrointestinal (GI) anastomosis procedures.

Sylys Surgical Sealant helps reduce anastomotic leakage in GI procedures by providing additional support to the anastomosis during the first few days of healing, when the development of leaks is most likely to occur. The elastic, resorbable, synthetic sealant protects the suture or staple line used in standard anastomotic closure techniques, supporting the anastomosis during the first few days of healing when leaks are most likely to occur. The rapid curing, single-part sealant provides good adherence to tissue, creating a flexible, elastic seal over the anastomosis site.

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The curing process is initiated by contact of the viscous fluid with the moisture in the tissue. The cured sealant forms a network of large polymeric chains that allows it to remain soft and flexible, while also creating a strong tissue bond. The sealant remains well adhered to the tissue during the first two weeks after surgery, and then proceeds to break down into harmless subcomponents over a period of three months. Burst strength testing of the product shows that it is able to withstand pressures over 150 mmHg, twice that of normal bowel peristalsis. Sylys Surgical Sealant is a product of Cohera Medical (Pittsburg, PA, USA; www.coheramedical.com), and has received the European Community CE marking of approval.

“Sylys enhances standard closure techniques, advancing the healing process and reducing postoperative complications,” said Patrick Daly, President and CEO of Cohera Medical. “We are a step closer to providing patients with the best opportunity for a successful outcome following intestinal anastomosis procedures.”

Image: The Sylys Surgical Sealant placed over an anastomosis staple line (Photo courtesy of Cohera Medical).

Elective Cesarean Section Risks Outweigh Benefits new review states that cesarean section is associated with increased risks to both mother and child, and should only be performed when it is clearly advantageous.

Researchers at Ludwig-Maximilians-Universität (LMU; Munich, Germany; www.uni-muenchen.de) conducted a review of studies to understand the rising worldwide trend of elective cesarean section, including cesarean delivery on maternal request (CDMR). The study was based on pertinent publications that were retrieved by a selective search in the PubMed, Scopus, and DIMDI databases, as well as on media communications, analyses by the German Federal Statistical Office, and the guidelines of the Asso-

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ciation of Scientific Medical Societies in Germany (AWMF; Düsseldorf, Germany; www.awmf.org).

The researchers found that rates of cesarean section have doubled. In 1991, 15.3% of all newborn babies in Germany were delivered by cesarean section; by 2012, the corresponding figure was 31.7%, despite the fact that a medical indication was present in less than 10% of all cases. According to the researchers, changes in the risk profile of mothers and fetuses have contributed to the rise in cesarean and CDMR rates. These include increased maternal age, pre-existing maternal disease – such as diabetes mellitus or gestational diabetes, overweight, and obesity – and assisted reproductive interventions, which

increasingly lead to multifetal pregnancies.

In addition, a previous cesarean section seems to contribute to a sense of security of both physicians and mothers in subsequent cesarean deliveries. One reason could be that with vaginal birth after previous cesarean delivery there is a risk of rare but serious adverse outcomes, whereas with repeat cesarean the risks are more frequent, but less serious. Finally, legal aspects of defensive obstetric practice have led to many doctors avoiding working in obstetrics, with the result that several large areas of Germany are left without obstetric care. The review was published in the August 2015 issue of Deutsches Ärzteblatt International.

Pre-Shaped Guidewire Sized for Smaller Ventricles n enhanced version of the Safari guidewire facilitates the introduction and placement of interventional devices within the heart.

The Boston Scientific Safari2 pre-shaped guidewire is designed to offer streamlined device delivery with enhanced wire predictability and shape retention for placing interventional devices within the heart, including those used with transcatheter aortic valve implantation or replacement procedures (TAVI/R). The Safari2 product line offers a wide choice with three curve sizes, including a new extra small curve designed for procedures involving patients with smaller ventricles. Prior to the Safari guidewire, physicians used peripheral intervention guidewires manually shaped for TAVI procedures.

The Safari2 Guidewire is designed to complement the Boston Scientific Lotus Valve System, a next-generation TAVI/R device designed to give physicians more control throughout the procedure.

The Lotus Valve System offers an alternative treatment for patients with severe aortic stenosis who are at high risk for surgical valve replacement. The Safari and Safari2 guidewires and the Lotus Valve System are products of Boston Scientific (Natick, MA, USA; www.bostonscientific.com), and have received the European Community CE marking of approval. They are distributed separately.

“The Safari2 Guidewire reflects our dedication and our commitment to meaningful innovation in the treatment of structural heart disorders,” said

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Tom Fleming, vice president and general manager of the structural heart division at Boston Scientific.

“Having a pre-shaped, universal TAVR guidewire helps physicians deliver the replacement valve with reliability and consistency,” commented Wesley Pederson, MD, director of valve and structural heart disease at the Minneapolis

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Heart Institute Foundation (MHIF; MN, USA; www.mplsheart.org). “This is a wonderful development to have a smaller curve size so that we can offer this less invasive treatment option to a broader range of patients, because valvular disease can have a devastating impact on patient survival and quality of life.”

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PRODUCT NEWS MEDICAL MONITOR

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MEDICAL REVIEW MONITOR

CVIS-PACS SOFTWARE

Barco

Dell

Ebit

The MDSC-8232 is a 32-inch 4K monitor intended for laparoscopic visualization, as well as for use within the interventional radiology control room. It is available with an integrated Nexxis 4K decoder to work perfectly together with Barco’s Nexxis platform for video-over-IP integration in the OR.

The MR2416 is sealed with an edge-to-edge frontcovered glass, and is DICOM-calibrated for accurate and consistent image display during every clinical review. It also meets medical design standards and safety requirements for medical electrical equipment with IEC 60601-1 compliance.

The Suitestensa CVIS-PACS encompasses all cardiology specialties and allows diagnostic image acquisition, archiving, distribution and management within healthcare networks. It enables doctors to access and track current/previous patient reports, images, and test results.

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Liège University Hospital and Agfa to Enable Improved Information Sharing entre Hospitalier Universitaire de Liège (CHU; Belgium; www. chuliege.be) and Agfa Healthcare (Mortsel, Belgium; www. agfahealthcare.com) have launched an innovative Portal project to promote greater information sharing with external caregivers. The Portal is intended to provide easy, authorized access to images and reports, replacing the current CD distribution system with a more accessible, secure way to share information with caregivers outside the hospital that is in-line with the CHU high level, long term CAP 2020 strategy.

“CD burning technology has become more outdated compared to other innovations in the digital age, and it no longer answers our needs or the needs of the referring physicians and patients we serve,” said computer scientist Gregory Canivet, RIS/PACS/ cardio application manager at CHU Liege. “We wanted to replace all CD-burning activity in the radiology department with a patient & referral portal that would give easy, fast access to the patient’s images using the most up-to-date technology. But it would need to be a solution that could scale up in the future to include more and more information.”

To implement the new Patient & Referral Portal solution, CHU de Liège and Agfa HealthCare installed the XERO Viewer, which was directly connected to the hospital’s existing Agfa HealthCare picture archiving and communication system (PACS). XERO converts images and content for display with-

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out requiring any client software installation. Very intuitive to use, it includes advanced clinical tools for the referring physician and is based on upto-date web technology. Importantly, the single platform and direct connection allow access to the patient’s complete image history, from all five of the hospital’s sites.

“We have a very positive relationship with Agfa HealthCare and their team worked in close collaboration with our own team on this project.

“They were able to offer us a unique technology concept: putting the PACS backend and the XERO Viewer on the same platform,” continued Gregory Canivet. “This means we don’t need an extra cache, saving us storage and hardware costs. With a single cache there is no risk of error due to synchronization, while a second cache is also slower. So this unique platform set-up is more effective and faster.”

The project team and Agfa HealthCare also worked closely with the CHU IT department to develop and implement an e-ID based security system for secure authentication, without making the login process too complicated for users. To access their images, patients need a standard e-card reader, a Belgian electronic ID card, and their PIN number for the ID card. For referring physicians, their unique identifier (INAMI code) was mapped to their national ID number, so they are automatically identified as such when they connect.

When a patient checks in at the reception, the secretary indicates in the system whether a Portal access code must be generated on the report, and prints out a unique access code for the patient. The validated report automatically includes the access code, and it is printed on a centralized printer. The reports are then sent to the referring physician by post or by a secure messaging system; additional specialists or GPs who need to receive the report and access the images can be easily included in the email.

Patients and referring physicians also receive a link for each request, allowing them to connect any time they wish to the Portal webpage, which is integrated directly into the hospital’s website. The referring physician can access both images and reports, while the patient can see images only; this enables patients to get a proper explanation of images and results from their own doctor.

“The patients have been very positive about the Portal. Being able to access, download and share their images makes them feel part of a more transparent process. In the first week, between 10 and 20 patients logged in each day. By week four, that number had reached 100 per day,” concluded Mr. Canivet.

“The referring physicians are also quickly adopting the Portal; in the first four weeks following the launch, 96 had already connected. And even our internal clinicians appreciate the DICOM export functionality, which allows them to use the images for other purposes, such as conference calls, case studies, and more.”

The Portal is also complementary to the “Réseau de Santé Wallon,” which allows sharing of digitalized images and other patient information across the region of Wallonia (Belgium).

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Enterprise Imaging Platform Simplifies Accessibility of Clinical Data new enterprise imaging platform from a major imaging vendor is being announced at the Radiological Society of North America (RSNA 2015) annual meeting. The platform includes workflows, and tools to consolidate medical images, and facilitate the dissemination of a patient’s Electronic Imaging Record (EMR) within an enterprise. The use of a single standardized platform results in increased clinical efficiency, and reduced Internet Technology (IT) costs. The platform also spurs innovation in enterprise strategy.

Agfa HealthCare (Mortsel, Belgium; www.agfahealthcare.com) announced the platform and it simplifies the creation of a single comprehensive patient imaging record. The platform has a modular construction and can be deployed in stages, beginning with enterprise viewing, storage, image capture, diagnostic departmental solutions, and a healthcare portal, and can be expanded to become a complete medical imaging solution.

The platform facilitates access to images using a secure portal, and specialized departmental workflows and tools for radiology, orthopedics, cardiology, ophthalmology, dermatology, and nursing care. The platform also enables real-time collaboration and sharing of information. The platform includes a Vendor Neutral Archive (VNA), and Information Lifecycle Management, increasing data integrity, saving time, and reducing costs. The platform also enhances reporting by enabling sectional reporting for radiologists, and next generation structured reporting for cardiologists. The Enterprise Imaging platform can also be deployed remotely as a hosted SaaS (Software as a Service). The platform consists of several 64-bit servers ensuring availability, and disaster recovery, and scalability, and be used in cluster mode.

James Jay, global vice president, Imaging IT solutions, Agfa HealthCare, said, “Agfa HealthCare Enterprise Imaging is a truly new platform: it is not a PACS add-on, but instead based on new technology. It has been a key part of Agfa HealthCare’s strategy for a long time, and demonstrates the unrivalled

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value we add as an enterprise imaging provider. But our approach goes beyond the technological: Agfa HealthCare acts as a trusted advisor and provider to healthcare enterprises all the way along this journey to assure a successful implementation.”

Image: The Enterprise Imaging platform offers a care-centric workflow that is standards-based, improves interoperability and enables a comprehensive patient health record across departments within a single facility or between multiple facilities (Photo courtesy of Agfa HealthCare).

In-Procedure Ablation Confirmation Software Receives FDA Clearance he first and only in-procedure ablation confirmation software that is part of an ablation system, and is intended for the ablation of soft tissue lesions, has received clearance from the US Food and Drug Administration (FDA; Silver Spring, MD USA; www.fda.gov).

The software was developed by a privately held medical device company and is intended for use with their ablation system. The software uses images from Computed Tomography (CT) scanners and Picture Archiving and Communication Systems (PACS) and helps clinicians identify ablation targets, assess correct placement of ablation probes, and confirm post procedure ablation zones.

The Ablation Confirmation (AC) software, user interface, and NewWave Intelligent Ablation system were developed by NewWave Medical (Madison WI, USA; www.neuwave.com). The AC software imports images from a CT scanner and PACS, and displays them on a dedicated monitor on the NewWave Intelligent Ablation system.

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Carestream Updates Healthcare IT Platform arestream has released updates for an advanced Internet Technology (IT) healthcare platform at the Röntgenveckan Radiology congress in Malmo (Sweden). The IT platform facilitates collaboration by enabling sharing of critical patient information such as Radiology images, videos, reports, and services with groups outside of the Radiology department, and allows retrieval of structured data, and interactive reports.

The Clinical Collaboration Platform (CCP) was developed by Carestream (Rochester, NY, USA; www.carestream.com) and can be used in conjunction with existing Picture Archiving and Communication Systems (PACS), Vendor Neutral Archives (VNA), and Electronic Medical Records (EMR) for example, to manage medical data, and improve the efficiency of clinical management processes.

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PRODUCT NEWS DOSE MANAGEMENT SOFTWARE

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IMAGE VIEWER

AFTER-HOURS APP

GE Healthcare

IDS

Sphinx Medical Technologies

The DoseWatch Explore is a web-based, cloud deployed, introductory dose management software designed to track, analyze and report practice-level data for GE CT systems. It collects radiation dose data directly from CT scanners, then summarizes/presents the data via a web app.

The The zero-footprint AbbaDox HTML5 DICOM image viewer requires no client installation and is compatible with all modern web browsers that are HTML5-compliant. Users can also access the image viewer through native apps on the iPhone, iPad, and Android mobile devices.

The Patient Self-Scheduler allows patients to make appointments without a receptionist or office staff. The after-hours smartphone app allows a physician to respond to a patient call using either voice, text or message response choices, while being able to access the complete patient record.

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Hackers Successfully Breach UCLA Health System CLA Health (Los Angeles, CA, USA; www.uclahealth. org) admitted on July 17, 2015, that it has been hit by a cyber-attack, with hackers successfully accessing parts of the computer network that

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include personal and medical information. UCLA Health first found evidence of suspicious activity in its network in October 2014; in May 2015, the hospital system determined the attackers accessed parts of its network that con-

Image: The Ronald Reagan UCLA Medical Center (Photo courtesy of UCLA Health).

tained personal patient information, including names, addresses, birth dates, medical record numbers, social security number (SSN), Medicare or health plan ID numbers, with some of the information dating to 1990. UCLA Health said it currently has no evidence whether the cyber attacker actually acquired any personal or medical information of the 4.5 million individuals in the database.

While credit card and other financial information did not seem to be involved, UCLA is offering a year as of credit monitoring to people who had their SSN or Medicare ID numbers stored on the compromised network, and are working with investigators from the Federal Bureau of Investigation (FBI; Washington DC, USA: www.fbi.gov) to solve the issue.

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ed, according to data from the US Department of Health and Human Services (HHS; Washington DC, USA; www.hhs.gov).

“Our patients come first at UCLA Health and confidentiality is a critical part of our commitment to care. We sincerely regret any impact this incident may have on those we serve. We have taken significant steps to further protect data and strengthen our network against another cyber-attack,” said James Atkinson, MD, president of UCLA Hospital System.

UCLA Health operates four hospitals on two campuses, including the Ronald Reagan UCLA Medical Center, the UCLA Medical Center of Santa Monica, the Mattel Children’s Hospital UCLA, and the Resnick Neuropsychiatric Hospital at UCLA. It also has 150 primary and specialty offices throughout southern California.

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Health IT

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Digital Attachment Transforms Stethoscope Auscultation new analog stethoscope adaptor enables heart sounds to be recorded digitally using Bluetooth connectivity and presented via a smartphone app.

The Eko Core next generation digital stethoscope attachment is designed for insertion into the tubing of traditional Littmann Cariology III-style stethoscopes, enabling clinicians to switch between analog and digital modes. Using a Bluetooth-connected mobile app (currently available only for Apple devices), clinicians can study a visual representation of the heart sound waveform, save the heart sounds directly to a patient’s electronic health record (EHR), and securely collaborate with a cardiologist for a second opinion.

The Eko Core, a product of Eko Devices (Berkley, CA, USA; www.ekodevices.com), will also be available as a fully digital device for doctors willing to forgo analog auscultation entirely. The

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company, which has already established EHR partnerships with Dr. Chrono, Allscripts (Chicago, IL, USA; www.allscripts.com), Practice Fusion, Cerner (Kansas City, MO, USA; www.cerner.com), Epic, and Athena Health, is also working on a groundbreaking algorithm, which they call “the Shazam for heartbeats,” that will support decision-making and will be included in the mobile app.

“One of the most exciting aspects of having digital heart sounds would be the ability to provide clinicians with decision care support,” said Jason Bellet, chief operating officer of Eko Devices. “We are working with scientists and some cardiology advisors to build out a decision support algorithm that will help clinicians at the point of care determine characteristics of heart sound, such as a murmur, intensity, and location, and then ultimately be able make more informed care decisions.”

“The stethoscope is an iconic and universal part

of medical practice, a tool which nearly every doctor, nurse, and student learns to use,” said cardiologist John Chorba, MD, of the University of California, San Francisco (UCSF, USA). “The beauty of the Eko Core is that it captures the heart sounds in a streamlined way that has never been done before, interfacing seamlessly into our traditional exam without requiring any extra effort.”

Image: The Eko Core digital stethoscope attachment (Photo courtesy of Eko Devices).

Novel Mouthguard Monitors Health Markers new mouthguard can monitor uric acid in the saliva and transmit the information wirelessly to a smart phone, laptop, or tablet. Developed at the University of California, San Diego (UCSD; USA;

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www.ucsd.edu), the mouthguard monitor uses printed sensor technology based on silver, Prussian blue ink and uricase, an enzyme that reacts specifically with uric acid. Because human saliva is an extremely complex

viscous liquid that contains many different biomarkers, the researchers set up the chemical equivalent of a twostep authentication system to make sure that the sensors only reacted with the uric acid. Similar sensors are also being developed for lactate and cortisol.

The first step is a series of chemical keyholes, which ensures that only the smallest biochemicals get inside the sensor. The second step is a layer of uricase trapped in polymers, which reacts selectively with uric acid. The reaction between acid and enzyme generates hydrogen peroxide (H2O2), which is detected by the Prussian blue ink. That information is then transmitted to an electronic board, which that senses the output of the sensors, digitizes the output, and then wirelessly transmits data to a smart phone, tablet or laptop.

The researchers conducted a study using saliva samples from healthy volunteers and spread them on the sensor, which produced read-

ings in a normal range. Next, they collected saliva from a patient who suffers from hyperuricemia, a condition characterized by an excess of uric acid in the blood; the sensor detected more than four times as much uric acid in the patient’s saliva than in the healthy volunteers. When the patient took Allopurinol, they were able to document a drop in uric acid levels over four or five days as the medication took effect. The study was published in the September 2015 issue of Biosensors and Bioelectronics.

“The ability to monitor continuously and noninvasively saliva biomarkers holds considerable promise for many biomedical and fitness applications,” said lead author Professor of nano-engineering Joseph Wang, PhD, of the Center for Wearable Sensors at UCSD. “It could be used in the future to monitor hospitalized patients continuously without the need for invasive procedures, monitor athletes’ performance, or study stress levels in soldiers and pilots.”

VISIT US AT: STAND # 1B10 - ARAB HEALTH U.S. INTERNATIONAL PAVILION

Image: The UCSD uric acid mouthguard monitor (Photo courtesy of UCSD).

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Ajman Hospital to Focus On Medical Tourism he Thumbay Group (Ajman, UAE; www.thumbay.com) will open a new GMC (Ajman, UAE; www.gmchospital.com) hospital in Al Jurf (Ajman).

The new 300-bed GMC Hospital, which is expected to be completed by 2018, will be the teaching hospital of Gulf Medical University (Al Jurf, UAE; www.gmu.ac.ae). The new GMC Hospital will be the largest private hospital in the northern United Arab Emirates (UAE), and will lay special emphasis on medical tourism, as the population of Ajman is just 250,000. As part of the strategic plans for the hospital, the Thumbay Group is planning to open representative offices in 20 countries, and expects to have about 1,000 patients as medical tourists per day within six years.

The four-story, 120-clinic hospital will feature a robotic pharmacy and a radiology department with positron

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emission tomography and computed tomography (PET/CT) scan, a first of its kind in the northern emirates. The state of the art analytics laboratory will be connected to the Gulf Medical University Center for Advanced Biomedical Research and Innovation (CABRI) via an unmanned chute, to offer highly specialized tests and diagnostic facilities.

The first stage of development plans include a 50-unit dental care center and a hi-tech rehabilitation center, which will have physical therapy, speech, hearing, and occupational therapy specialties, as well as sports medicine facilities with state of the art labs, including a motion and gait analysis laboratory. The rehabilitation center will be constructed in three floors and will also train the physical therapy students of the university.

Both dental and rehabilitation centers are expected to be ready for business

by September 2016.

“We are confident that the new hospital, to be constructed within the university campus will become a leading name in healthcare in the region,” said Thumbay Moideen, founder and president of Thumbay Group. “Our chain of hospitals aims to be the leading network of academic hospitals in the Middle East. The main focus is to provide patient centered care of the highest quality in an academic set up.”

The GMC chain of hospitals is one of the largest health care providers in the UAE, with hospitals and medical centers in Ajman, Fujairah, Sharjah, and Dubai. The highly skilled medical work force is made up from 20 nationalities, speaking more than 50 languages, treating guests from more than 175 nationalities worldwide.

Image: An artist’s rendition of the new GMC Hospital at Al Jurf (Photo courtesy of the Thumbay Group).

San Francisco’s New Chinese Hospital Nears Completion he new Chinese Hospital (San Francisco, CA, USA; www.chinesehospital-sf.org) plans to offer world-class care to the community it has served for generations.

The new 8-story Chinese Hospital will have increased space for patient care, improved privacy, and advanced medical technology to meet rising demand for services. Among the service to be provided are an expanded emergency treatment center, expanded cardiopulmonary unit, a new diagnostic and magnetic resonance imaging (MRI) de-

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partment, two additional operating rooms, 44 private acute care patient rooms, 6 intensive care unit (ICU) beds, a skilled nursing unit with 23 Beds, and expanded pharmacy services.

The new hospital will stand at the location of the original 1925 building, which was demolished to make room for the new structure. The hospital is currently operating in an annex that opened in 1979 to serve the healthcare needs of the Chinese community in the Greater San Francisco Bay Area, but has since become overcrowd-

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ed. The Chinese hospital remains the only Chinese operated and governed independent hospital in North America.

To finance the new hospital, a USD 160 million capital campaign was launched to help build the replacement facility and enable Chinese Hospital to enhance services, expand patient floor space, and invest in new innovative equipment throughout the hospital. The new building will use construction materials, streetscaping, and open space designs that blend with the cultural context of Chinatown and comply with California’s new seismic safety standards.

“We need your help to rebuild and strengthen our services for you, your family, friends, and neighbors and provide the highest quality of care.

You don’t have to be a doctor to save lives,” said Linda Schumacher, chief operating officer of Chinese Hospital. “The success of this project requires a partnership between Chinese Hospital and the community. The question should not be whether or not to participate, but at what level you can help to support the essential healthcare needs of our community.”

Chinese Hospital was founded by 15 Chinatown community organizations to offer medical services designed around the language and culture of their patients, who spoke little or no English. Martial arts hero Bruce Lee was born there in 1940. Since 15,000 residents live within the 20-square-block Chinatown area, the technically complex and logistically challenging project has required keeping neighbors and local vendors at the bustling fish and produce markets abreast of construction activities.

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To view this issue in interactive digital magazine format visit www.LinkXpress.com

Hospital News

Philips Signs “Smart Hospital” Deal in Ontario oyal Philips (Philips; Amsterdam, The Netherlands; www.philips.com) will provide two Mackenzie Health (Richmond Hill, ON, Canada; www.mackenziehealth.ca) hospitals with medical technology procurement, management, and maintenance services over the next 18 years. The managed equipment services model will allow Mackenzie Health to have access to state-of-the art equipment – including those of other vendors – and services under a single payment structure that includes procurement, installation, systems integration, maintenance and timely updates to ensure that the hospitals will be provided with the medical technologies that their departments require for the optimal delivery of care. The collaboration further includes a broad range of services, including room design, cloud-based predictive analytics, and diagnostic technologies.

Under the deal, which is valued at USD 225 million, Philips will offer systems interoperability, diagnostic imaging equipment utilization, radiology practice management, patient-centric design, and alarm management offerings to the existing Mackenzie Richmond Hill Hospital and the future Mackenzie Vaughan Hospital, which is slated to be completed in 2019. Philips and Mackenzie will also work to incorporate all manner of connected health technologies, as well as explore how to elicit patient data that can be used to improve clinical outcomes and reduce costs.

“The new Mackenzie Vaughan Hospital has the potential to transform the lives of residents in our community, who are in need of quality care throughout their healthcare journey,” said Altaf Stationwala, President and CEO of Mackenzie Health. “We chose Philips not only for their products, but also for their expertise and solutions. Mackenzie Health is committed to working with our healthcare partners to deliver a state-of-the-art hospital as part of our vision to create a world-class health experience for the people of Southwest York Region and beyond.”

“Forward-thinking organizations such as Mackenzie Health understand that in order to transform healthcare and deliver the type of care their communities need and deserve, they need public-private partnerships with industry-leaders like Philips that have a proven track record of industry expertise and innovation,” said Iain Burns, CEO of Philips Canada. “It takes more than just technology to deliver the right solutions, you need to have a deep understanding of the consumer and the healthcare industry to apply best practices for effective patient-centric care.”

Opened in 1963, Mackenzie Richmond Hill Hospital has 350 acute, complex and rehabilitation beds and serves more than 500,000 residents in Southwest York Region, one of the fastest growing communities in Canada. The new 350-bed “smart” Mackenzie Vaughan Hospital will be the first new hospital in the area in more than 50 years, and will embrace connected health technologies in a stateof-the-art emergency department (ED), modern surgical services and operating rooms, medical imaging, specialized ambulatory clinics, and a flexible design that will enable it to evolve as new thinking and best practices emerge.

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Image: The Mackenzie Richmond Hill Hospital

(Photo courtesy of Royal Philips)

Hospital News

Roche Opens Diagnostics Training Center in Liverpool Hospital oche (Basel, Switzerland; www.roche.com) has opened a new diagnostics training laboratory and regional center of excellence at the Royal Liverpool University Hospital (RLUH; United Kingdom; www.rlbuht.nhs.uk/Pages/ RoyalHome.aspx).

The facility, which is part of Liverpool Clinical Laboratories (United Kingdom; www.liverpoolcl.nhs.uk), will provide training for more than 1,000 hospital and laboratory staff a year from across North West England, as part of the ongoing commitment of Roche to training and excellence in diagnostics. At the center, staff will be trained on how to use the latest diagnostic innovations and technologies at point of care (POC) within the hospital.

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“Roche is committed to excellence in diagnostic testing no matter where it is carried out,” said Christopher Parker, managing director of Roche Diagnostics UK and Ireland. “We are focused on going beyond the development of the latest product innovations to also ensuring that patients have timely access to the safest and most accurate testing possible.”

“Ensuring doctors have access to accurate test results is an essential component of delivering the highest quality care for our patients,” said Jane Mills, chief operating officer of Liverpool Clinical Laboratories. “It is often the unsung hero of medicine, but up to 70% of clinical decision-making is based on diagnostic testing.”

Chinese Group to Acquire Australian Hospital Chain LINKXPRESS COM

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uye Medical Group (Beijing, China; www.luye.cn) has entered into an agreement to acquire Australian private hospital operator Healthe Care (Sydney, Australia; www.healthecare.com.au) for USD 688 million.

The third largest corporate private hospital operator in Australia, Healthe Care operates a portfolio of 17 hospital sites in major cities and key regional areas across Australia, with over 1,800 beds, 50 operating theaters, and 4,500 employees. Healthe Care was bought by private-equity firm Archer Capital (Sydney, NSW, Australia; www.archercapital.com.au) in 2011, and since then has company has steadily expanded with a series of acquisitions, including Townsville Private in 2014 and Robina Private earlier in 2015.

For Luye Medical, the agreement marks the company’s 's first entry into the overseas hospital sector, with stated purpose of helping to meet higher demands on China's healthcare sector. Luye Medical, a division of the Luye Group, currently operates a network of healthcare service facilities across major cities in China, focusing on key therapeutic areas, in-

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cluding rehabilitation nursing, plastic surgery, postpartum nursing, geriatric medicine, and dentistry.

“There are very few private hospital portfolio acquisition opportunities anywhere in the world, and to be able to enter the Australian market with an acquisition of scale such as Healthe Care represents a great opportunity,” said Liu Dian Bo, chairman of Luye Group. “I strongly believe that Healthe Care will provide us with a platform upon which we can build a world class and highly successful healthcare services business not only in Australia and China, but also in many other countries in Asia.”

“I have spent a considerable amount of time over the past several months getting to know the Luye Medical management team and have been impressed by their vision and strong commitment to continue funding the expansion of healthcare services at Healthe Care,” said Steve Atkins, CEO of Healthe Care. “I am looking forward to working with Luye Medical’s executives and benefitting from their healthcare expertise as we further our strong partnerships with Healthe Care’s doctors and staff to deliver the highest standards of patient care.”

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Industry News

German Respiratory Gas Leader to Buy US Counterpart he Linde Group (Munich, Germany; www.linde.com), the largest gases engineering company in the world, has announced a definitive agreement to purchase American HomePatient (Brentwood, TN, USA; www.ahom.com).

Under the terms of the agreement, American HomePatient will be merged into Linde subsidiary Lincare (Clearwater, FL, USA; www.lincare.com), which provides respiratory services and equipment in approximately 1,000 locations across the 48 contiguous US states and Canada. The deal will make Linde the world's largest supplier of healthcare gases, helping to counteract weakness at its core industrial businesses due to a slowdown in industrial production and low oil prices that have hit customers in the petrochemical sector.

American HomePatient, founded in 1983, is one of the top five largest diversified home healthcare providers in the United States, with more than 220 locations, and specializes in respiratory therapies for patients with chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA). The company was sold to Linde by private equity group Highland Capital Management (Dallas, TX, USA) for an undisclosed amount. The deal is expected to close in the first quarter of 2016.

“The acquisition of American HomePatient will further our strategic growth as we strive to set the standard of excellence for respiratory care delivered in the home,” said Kristen Hoefer, CEO of Lincare. “Our dedication to quality care, professionalism and responsiveness has helped us achieve consistent growth and success, and we look forward to this opportunity to work with the employees and customers of American HomePatient.”

“This decision follows many months of strategic research, with the support of Highland Capital Management and our advisor Jefferies, LLC, and careful consideration to determine the best opportunity for our company,” said Mark Lamp, CEO and President of American HomePatient. “We are pleased to have found a partner in Lincare that placed a value on our growth, performance and experience. We look forward to working together to deliver on our shared commitment to outstanding customer service.”

“Under Highland's ownership, American HomePatient benefited from our strategic and operational resources, which helped its management team achieve strong growth while providing high-quality care to patients nationwide,” said Matt Jameson, co-head of Highland Capital Management, and Chairman of the Board at American HomePatient.

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Consolidation in US Health IT Sector omputer Programs and Systems (CPSI; Mobile, AL, USA; www.cpsi.com) has signed an agreement to buy Healthland Holding (Minneapolis, MN, USA; www.healthland.com) and its affiliates, Healthland, American HealthTech, and Rycan Technologies for USD 250 million. The transaction is intended to strengthen CPSI's capabilities in providing healthcare information solutions to community healthcare organizations, including 1,200 combined hospital customers. The transaction will also introduce CPSI to the post-acute care market by expanding the products and capabilities of its subsidiary TruBridge, which provides healthcare solutions to community hospitals.

Healthland offers electronic health records (EHR) and clinical information management solutions to more

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than 350 hospital customers; American HealthTech provides clinical and financial solutions in the postacute care sector, serving 3,300 skilled nursing facilities; and Rycan Technologies is focused on providing software as a service (SaaS) -based revenue cycle management workflow and automation software to 290 hospital customers. “Healthland's history tracks a very similar course to that of CPSI, as we both have over 30 years of experience in the healthcare IT space, and we share a strong commitment to the improvement of community healthcare,” said Boyd Douglas, president of CPSI. “Together, we will service a client base of approximately 1,200 acute care facilities and more than 3,300 post-acute care facilities, including Healthland's American HealthTech subsidiary.”

International Calendar For a free listing of your event, or a paid advertisement in this section, contact:

International Calendar, HospiMedica International P.O.Box 802214, Miami, FL 33280-2214, USA Fax: 1-954-893-0038 • E-mail: info@globetech.net FEBRUARY 2016 ISET 2016 – International Symposium on Endovascular Therapy. Feb 6-10; Hollywood, FL, USA; Web: http://iset.org Saudi Heart Association Annual Meeting. Feb 12-16; Riyadh, Saudi Arabia; Web: www.saudiheart.com Africa Laborum 2016. Feb 18-20; Kenya, Africa; Web: http://kenyalaborum.com SCCM 2016 - 45th Annual Meeting of the Society for Critical Care Medicine. Feb 20-24; Orlando, FL, USA; Web: www.sccm.org MEDICAL JAPAN. Feb 24-26; Osaka, Japan; Web: www.medical-jpn.jp/en HIMSS Annual Meeting 2016 - Health IT Conference and Exhibition. Feb 29-Mar 4; Las Vegas, NV, USA; Web: www.himssconference.org

MARCH 2016 ICID 2015 – 17th International Congress on Infectious Diseases. Mar 2-5; Hyderabad, India; Web: www.isid.org ECR 2016 – European Congress of Radiology.

Mar 2-6; Vienna, Austria; Web: www.myesr.org Medical Fair India 2016. Mar 11-13; Mumbai, India; Web: www.medicalfair-india.com Annual EAU Congress 2016- European Association of Urology. Mar 11-15; München, Germany; Web: http://eaumunich2016.uroweb.org Kuwait Medica. Mar 12-14; Al Kuwayt, Kuwait; Web: www.kuwaitmedica.com 36th ISICEM - International Symposium on Intensive Care and Emergency Medicine. Mar 1518; Brussels, Belgium; Web: www.intensive.org KIMES 2016. Mar 17-20; Seoul, Korea; Web: www.kimes.kr ExpoMed Eurasia. Mar 24-27; Istanbul, Turkey; Web: www.expomedistanbul.com/en The 28th International Medical Instruments and Equipment Exhibition. Mar 25-27; Beijing, China; Web: www.chinamed.net.cn

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Anetic Aid . . . . . . . . . . . . .13 Ampronix . . . . . . . . . . . . .15 Bio-Med Devices . . . . . . .18 CMEF 2016 . . . . . . . . . . .34 CHINAMED 2016 . . . . . . .35 Cintrin . . . . . . . . . . . . . . . . .5 DTR . . . . . . . . . . . . . . . . .10 Echoson . . . . . . . . . . . . . .24 ECR 2016 . . . . . . . . . . . .29 Ertunc Ozcan . . . . . . . . . .11 Fluke Biomedical . . . . . . . .9 Hans Rudolph . . . . . . . . .28 HospiMedica.com . . . . . . .6 Hospitalar 2016 . . . . . . . .31 Intersurgical . . . . . . . . . . . .7 JDH . . . . . . . . . . . . . . . . .25 Joerns . . . . . . . . . . . . . . .20 Kare Medical . . . . . . . . . .32

– 122 108 130 126 114 127 117 136 104 132 121 103 102 116 112 119

KIMES 2016 . . . . . . . . . . .33 Lutech . . . . . . . . . . . . . . .22 MedGyn . . . . . . . . . . . . . . .8 MEKics . . . . . . . . . . . . . . .30 Mercury Medical . . . . . . .26 Metropolis . . . . . . . . . . . .14 Nova Biomedical . . . . . . .27 Parker Laboratories . . . . .17 Primedic . . . . . . . . . . . . . .36 Restorative Care . . . . . . .23 Sedecal . . . . . . . . . . . . . .32 Sidhil . . . . . . . . . . . . . . . .21 Siemens . . . . . . . . . . . . . . .3 Varian Medical Systems . .2 Vieworks . . . . . . . . . . . . .16 Viking / Brandon . . . . . . .12 Well.D . . . . . . . . . . . . . . .19

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