HospiMedica International September 2016

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Vol.34 No.5 • 8-9/2016

L E A D E R DAILY CLINICAL NEWS

ISSN 0898-7270

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System Treats Pancreatitis Complications novel stent and delivery system aids the endoscopic management of pancreatic pseudocysts and certain types of walled-off pancreatic necrosis. The AXIOS stent and electrocautery enhanced delivery system is designed to form a temporary anastomotic conduit between the diseased areas of the pancreas and the

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Cloud-Based Telehealth Network Connects Physicians and Patients virtual exam room (VER) telehealth system allows patients to interact in private with physicians and share medical images and data. The Dictum Health (Oakland, CA, USA; www.dictumhealth.com) VER is a completely private examination room that uses clinically accurate medical devices to allow patients to access a physi-

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cian and share real-time vital signs, cardiopulmonary data, and medical images over a secure, real-time connection. Using the IDM100 integrated medical tablet, patients can establish the physician-to-patient videoconferencing session. The tablet also stores and seamlessly synchronizes patient data to electronic medical records.

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Wearable Biosensors Enable Next-Generation Patient Monitoring

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Image: Courtesy of Royal Philips

novel all-in-one system helps preserve iliac artery blood flow in patients with common iliac artery aneurysms or aortoiliac aneurysms.

The Gore Excluder Iliac Branch Endoprosthesis (IBE) is a complete, fully engineered system that includes iliac branch and internal iliac components. The device is intended for use in conjunction with the Gore Excluder AAA Endoprosthesis to isolate the common iliac artery from systemic

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new implanted transponder can help enhance the precision of radiotherapy (RT) and radiosurgery treatments for cancer by providing real-time, continuous information on tumor position.

The Calypso 17G soft tissue Beacon transponder emits a non-ionizing electromagnetic signal that is tracked in real-time by the Calypso system, guiding treatment beams to target tumors during treatment with medical Cont’d on page 5

INSIDE

Elastographic Ultrasound Reduces Unnecessary Liver Biopsies

Health IT . . . . . . . . . . . . . . . . 29 Industry News . . . . . . . . . . . . 33 International Calendar . . . . . 34

premium-grade ultrasound system offers unique solutions, such as acoustic radiation force impulse (ARFI) elastography imaging, multi-modality review, and contrast-enhanced ultrasound.

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News Update . . . . . . . . . . . . . 6 Product News . . . . . . . . . .6-10

Stenting System Helps Treat Blocked Neck Arteries

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Iliac Branch System Helps Control Aneurysms

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Miniature Transponder Guides Radiotherapy

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revolutionary medical-grade biosensor can now provide monitoring solutions for at-risk patients in low-acuity hospital settings. Expanding upon wearable consumer trackers, the clinical biosensor continuously monitors heart and respiratory rates, skin temperature, single-lead ECG, posture, and activity data.

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novel system designed specifically for transcarotid artery revascularization (TCAR) helps prevent stroke in patients with carotid artery disease.

The Enroute NeuroProtection System (NPS) is designed to enable the insertion of a stent directly into the carotid artery in the neck, instead of using a percutaneous route through

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the groin and up the femoral artery, reducing the surgical risks and potential complications associated with more invasive procedures. In addition to TCAR access, the procedure also protects the brain during the intervention via flow reversal, a mechanism that redirects blood flow away from the Cont’d on page 4

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

News Update . . . . . . . . . . . . 22 Product News . . . . . . . . .22-28

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Cloud-Based Telehealth Network Connects Physicians and Patients cont’d from cover

With the assistance of auxiliary devices, the IDM100 can capture three and 12 lead electrocardiogram (ECG) readings, and can also serve as a digital stethoscope.

Two integrated cameras are used for face-to-face videoconferencing or to take an image. The auxiliary devices are used for weight, height, and body mass index (BMI) calculation; noninvasive blood pressure measurement; temperature reading; SpO2 pulse-oximetry and spirometry; and an audiogram hearing test. To take advantage of the auxiliary devices, the tablet is provided with both Bluetooth and USB connectivity.

At the other end, physicians enter the VER using the proprietary Care Central web interface from their laptop or tablet. When a virtual exam is conducted with the IDM100, the clinician can remotely view the patient’s diagnostic data in real time with the clinical accuracy of an in-office exam. Using Care Central, clinicians can also set and manage customized alerts and reminders for remote patient monitoring, and can make expedited clinical decisions by analyzing trends of biometric data. The Dictum Health VER platform and IDM100 integrated medical tablet have been approved by the US Food and Drug Administration (FDA).

“The Virtual Exam Room addresses the need for a highly mobile, patient centric model of care that reaches large populations in a way that the old brick and mortar, provider-centric model cannot,” said Elizabeth Keate, vice president of product management at Dictum Health. “What makes the VER stand out is its ability to deliver the same clinical quality as an acute care setting or physician office to patients at a remote location or in their home. This highly secure, portable, telehealth system reinforces the physician/patient relationship in a population health world.”

“Few patients require the level of continual, sophisticated monitoring that cardiac patients require,” said Susan Eisenberg, MD, medical director of the cardiac rhythm center at John Muir Health (Walnut Creek, CA, USA). “Dictum Health’s innovative virtual exam room delivers not only the highest level remote monitoring of our cardiac patients, but enables me as their cardiologist to be present with them in a way that wasn’t previously possible. That’s a critical element in patient-centric care.”

Image: The IDM100 integrated medical tablet (Photo courtesy of Dictum Health).

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HospiMedica International

Stenting System Helps Treat Blocked Neck Arteries cont’d from cover

brain so that it can carry any debris created to an external filter. This high rate temporary blood flow reversal is important to help protect the brain from stroke while surgeons subsequently deliver the Enroute Transcarotid Stent (TNS), a selfexpanding stent made of nickel-titanium (nitinol) alloy tubing, which is laser-cut into a mesh shape that opens automatically over the blockage. The Enroute NPS and TNS are products of Silk Road Medical (Sunnyvale, CA, USA; www. silkroadmed.com), and have been approved by the US Food and Drug Administration (FDA).

“Whereas elsewhere in the body we routinely use minimally invasive endovascular techniques to treat vascular disorders, carotid artery disease is one of the last frontiers that is still treated primarily by an invasive surgical approach,” said Professor Ralf Kolvenbach, MD, director of the department of vascular surgery and endovascular therapy at Augusta Krankenhaus hospital (Düsseldorf, Germany).

“With the Enroute NPS we can leverage surgical principles of neuroprotection like avoiding unprotected maneuvers, maintaining exquisite control of the carotid bifurcation and blood flow, and removing embolic fragments of any size.”

“We have been working to improve the safety profile of carotid revascularization through the development of the TCAR procedure, and this latest

medical-grade biosensor provides a monitoring solution for at-risk patients in low acuity hospital settings, such as the general ward.

Unlike fitness trackers and consumer-focused wearables, the new Royal Philips (Philips; Amsterdam, The Netherlands; www.philips.com) connected biosensor automatically and continuously measures heart rate, respiratory rate, skin temperature, single-lead electrocardiogram (ECG), posture, and activity data. The biosensor then transmits the data it collects to a clinical decision support software application, which can be configured to promptly notify the appropriate caregiver or clinician when preset limits are exceeded.

Development of the connected biosensor solution was driven by providers looking for models to address specific issues, such as helping at-risk patients in low acuity hospital areas through recovery and transition to home care, or to help caregivers detect early signs of patient deterioration so that they can intervene early. Philips further plans to introduce a portfolio of integrated solutions, which will also connect to analytics tools and dashboards, with the goal of providing clinicians actionable insights that could help improve patient outcomes, re-

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www.hospimedica.com A G L O B E T E C H P U B L I C AT I O N Publishers of: HospiMedica International • HospiMedica en Español HospiMedica China • Medical Imaging International • LabMedica International LabMedica en Español • LabMedica China • Bio Research International HospiMedica.com • MedImaging.net • LabMedica.com • BiotechDaily.com

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design of the Enroute NPS for TCAR is state-of-theart,” said Antonio Orgaz, MD, chief of vascular surgery at Virgen de la Salud Hospital (Toledo, Spain).

“We were extremely impressed with the smooth, atraumatic entry of the sheath into the carotid artery and the more ergonomic design of the overall system. It is easy to use and inspires confidence.”

Patients are typically referred for a carotid stent when they have a blockage of 70% or more in the carotid artery and are unsuitable candidates for endarterectomy, a procedure that involves general anesthesia, which could be dangerous for people with severe carotid blockages since they often also have blockages in other arteries, including the coronary arteries.

Image: The Enroute NeuroProtection System (NPS) (Photo courtesy of Silk Road Medical).

Wearable Biosensors Enable Next-Generation Patient Monitoring

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duce costs, and improve access to care.

“We envision a future where patients enabled by connected health technologies will recover faster with fewer complications and greater peace of mind in the hospital and subsequently at home,” said Carla Kriwet, CEO of patient care and monitoring solutions at Philips. “We see the potential for connected sensing solutions and the value created by the rich and actionable data they generate to have a very positive impact on the chronically ill, by helping to reduce associated costly adverse events, complications, unplanned transfers back to the ICU, and longer lengths of hospitalization.”

Philips recently revealed the HealthSuite Digital Platform, a system of wirelessly integrated health measurement devices that gather information for Philips personal health programs. All the devices are Bluetooth enabled, connecting automatically and transferring data to the Philips HealthSuite Health app, so that users can track measurements over time. Among these is the Philips health watch, which continuously and automatically measures a wide range of health biometrics, including heart rate, activity, and sleep patterns.

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ISSN 0898-7270 Vol.34 No.5 • Published, under license, by Globetech Media LLC Copyright © 2016. All rights reserved. Reproduction in any form is forbidden without express permission.

Teknopress Yayıncılık ve Ticaret Ltd. S¸ti. adına ˙Imtiyaz Sahibi: M. Geren • Yazı is¸leri Müdürü: Ersin Köklü Müs¸ ir Dervis¸ ˙Ibrahim Sok. 5/4, Esentepe, 34394 S ¸ is¸ li, ˙Istanbul P. K. 1, AVPIM, 34001 ˙Istanbul • E-mail: Teknopress@yahoo.com Baskı: Promat Web Ofset Tesisi • Orhangazi Mahallesi 1673. Sokak, No: 34 • 34510 Esenyurt, B. Çekmece • ˙Istanbul Yerel süreli yayındır. Yılda sekiz kere yayınlanır, ücretsiz dag˘ıtılır.

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Miniature Transponder Guides Radiotherapy cont’d from cover

linear accelerators. The size of a grain of rice, the 17G Beacon has a smaller cross-section area than the current, 14G version, and can be implanted within the soft tissue throughout the body, with the exception of the lung. The Calypso System can then deliver real-time, continuous three-dimensional (3D) tumor position information, improving clinician confidence that the prescribed dose has been delivered to the tumor.

Based on the transponder signals, the Calypso

Elastographic Ultrasound System Reduces Unnecessary Liver Biopsies cont’d from cover

The Acuson S3000 Ultrasound System, HELX Evolution with Touch Control is powered by an intuitive, user-centric interface on a 12.1-inch highresolution display with instant response technology that allows for precise key selections, promoting streamlined exam workflow efficiencies. This new usability concept also helps to eliminate unnecessary keystrokes and repetitive hand movements.

The interface features context-sensitive body markers, intuitive pictograms, transducer markers, and supportive, color-coded guidance annotations that suggest logical replacement text specific to the exam being performed.

A unique signal-processing algorithm optimizes integration between the transducer and the display by doubling the standard pixel density, resulting in high definition (HD) images that provide diagnostic confidence. Multimodality imaging, which combines the 3D topography of computerized tomography (CT) and magnetic resonance (MR) with realtime ultrasound, provides a range of clinical and spatial information for interventional procedures and complex ultrasound analysis. Smart initialization and auto-alignment help reduce examination time and effort.

With the aid of ARFI imaging, proprietary Virtual Touch (VT) technologies provide a new dimension of ultrasound information to evaluate tissue stiffness with shear wave elastography (SWE). Another advanced feature is in-depth anatomy imaging using contrast enhanced ultrasound (CEUS), which allows for the visualization of lesions in organs based upon vascularity and contrast harmonic imaging (CHI) for detail, and contrast pulse sequencing (CPS) for penetrating clarity. The Acuson S3000 Ultrasound System, HELX Evolution with Touch Control is a product of Siemens Healthcare (Erlangen, Germany; www.siemens.com/healthcare).

SWE relies on the lateral displacement of tissues induced by the force of a focused ultrasound beam or by external pressure that creates shear waves that are perpendicular to the direction of the generating force, travel slowly, and are rapidly attenuated by tissue; the propagation velocity of the shear waves correlates with the elasticity of tissue. The combination CEUS and SWE enhance the comparison of blood flow in the microcirculation with the mechanical and structural properties of tissue, giving even more diagnostic information.

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System can track even the slightest movement of the tumor without using ionizing radiation, and can precisely target even tumors that exhibit respiratory motion, as the system allows the beam to be gated on only when the tumor is in the planned position. The increased precision can enable treatment margin reduction, protecting healthy tissue and reducing side effects. The Calypso 17G soft tissue Beacon transponder and the Calypso System are products of Varian Medical Systems (Varian, Palo Alto, CA, USA; www.varian.com).

“The new 17G implantation device has half the cross-sectional area as the prior 14G technology, increasing patient comfort and improving access to tumors,” said Zachary Collins, MD, section head of interventional radiology at Kansas University Medical Center (Kansas City, USA).

Organ motion is variable and unpredictable, posing challenges during delivery of external beam RT

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treatments for cancer. The ability to track target motion in real time during treatment and gate the delivery beam can enable reduction in the margins between the clinical target volume (CTV) and the planning target volume (PTV).

Image: The Calypso 17G soft tissue Beacon transponder (Photo courtesy of Varian Medical Systems).

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Autofluorescent Bandage Detects Pathogenic Bacteria n intelligent hydrogel wound dressing glows green when it detects the presence of harmful bacteria in wound biofilms, potentially reducing the use of antibiotics.

Developed by researchers at the University of Bath (United Kingdom; www.bath.ac.uk), the University of Brighton (United Kingdom; www. brighton.ac.uk), and other institutions, the prototype wound dressing combines tiny vesicles containing a fluorescent dye mixed with agarose, which are then dispersed within a hydrogel matrix. When toxic bacteria come in contact with the vesicles within the hydrated agarose film, a reaction occurs that releases a dye that fluoresces, alerting attending healthcare professionals that the wound is infected.

The researchers tested the dressing in both static and dynamic mod-

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els of wound biofilms, using clinical strains of Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, and Enterococcus faecalis, which were used to establish a biofilm on a nanoporous polycarbonate membrane for periods of 24, 48, and 72 hours. The results indicated a clear fluorescent response within four hours, which was only observed when in contact with biofilms produced by a pathogenic strain. Similar responses were demonstrated on an ex-vivo porcine skin model of burn wound infection.

The sensitivity of the dressing to biofilms was dependent on the species and strain types of the bacterial pathogens involved, but a relatively higher response was observed in strains considered good biofilm formers. The researchers also found a clear difference in the levels of response when the dressings were test-

ed on bacteria grown in biofilm or in planktonic cultures, suggesting that the level of expression of virulence factors is different depending of the growth mode. The study describing to prototype dressing was published in the February 2016 issue of ACS Applied Materials & Interfaces.

“The nanocapsules mimic skin cells in that they only break open when toxic bacteria are present; they aren’t affected by the harmless bacteria that normally live on healthy

skin,” said senior author biophysical chemist Toby Jenkins, PhD, of the University of Brighton. “Using this dressing will allow clinicians to quickly identify infections without removing it, meaning that patients can be diagnosed and treated faster. It could really help to save lives.”

Image: The prototype of the ‘smart’ wound dressing: not infected (L), infected (R) (Photo courtesy of the University of Bath).

Body Fat Predicts Mortality Better Than BMI ody mass index (BMI) may not accurately reflect a person’s body composition or be a good indicator of health, according to a new study. Researchers at the University of Manitoba (Winnipeg, Canada; http://umanitoba.ca) conducted an observational study in 54,420 adults (49,476 women, 4,944 men) in their mid-60s to explore the associations of BMI and body fat percentage with mortality. All study participants underwent dual Xray absorptiometry (DXA) scans, entered a clinical registry, and were then followed using linked administrative databases. The patients were then divided into quintiles based on BMI and DXA-derived body fat percentage, with quintile 3 used as reference.

During the study period 4,965 of the women and

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984 of the men died. The results revealed that men and women with high body fat percentage – defined as greater than 38% in women and greater than 36% in men – were more likely to die over the next four to seven years. The results also showed that counterintuitively people with a lower BMI faced a greater risk of death, probably due to low muscle mass or frailty associated with chronic disease. The study was published on March 8, 2016, in Annals of Internal Medicine.

“In our society there’s been this mantra that thin is ‘in’ and being heavy is ‘bad.’ Someone with a lot of muscle mass, for example, may have a high BMI and, technically, fall into the overweight category,” said lead author William Leslie, MD. “The relationship between body size and health is more nuanced

than the number on your bathroom scale. It’s important to be attuned to what you’re made of, rather than just how much you weigh.”

BMI is a value defined as body mass divided by the square of body height, expressed in units of kg/m2. It was developed as an attempt to quantify the amount of tissue mass (muscle, fat, and bone) in an individual, and then categorize people as underweight, normal weight, overweight, or obese based on that value. However, there is some debate regarding where on the BMI scale the dividing lines between categories should be placed, while recent studies claim that other measures, such as waist-toheight ratio (WHtR) and body fat, are better predictors of health.

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Neuromodulation Device Helps Treat Overactive Bladder novel neuromodulation device targets bladder and brain miscommunication to help tens of millions struggling with overactive bladder (OAB). The NURO system delivers minimally invasive percutaneous tibial neuromodulation (PTNM), a periodic, office-based procedure that can provide a measurable reduction in urinary frequency, urinary incontinence, and urge incontinence episodes, without the side effects of medication. The device works by delivering a gentle electrical pulse to the tibial nerve via an acupuncture-like needle placed in the skin near the ankle, which is attached to the neurostimulator. The electrical stimulation is thought to indirectly activate the central nervous system (CNS) to help alleviate OAB symptoms.

The therapy is administered in a physician’s office during weekly 30minute sessions for 12 weeks, and thereafter as prescribed. Side effects are temporary, and include mild pain or skin inflammation at or near the stimulation site. In clinical trials, PTNM reduced the number of incontinence episodes and voids, the urgency and urge of incontinence episodes, and increased voiding volume. The NURO system is a product of Medtronic (Dublin, Ireland; www.medtronic.com), and has been approved by the US Food and Drug Administration (FDA).

“So many suffer from OAB, and the majority are either not treated or not finding relief with other treatments, so Medtronic is pleased to offer another option along the care pathway,” said Linnea Burman, vice president and general manager of gastro/urology therapies at Medtronic. “Our hope is that our expanding neuromodulation portfolio can help a broader range of patients get their lives back.”

“Many people with OAB are unsatisfied with current treatments and a significant number are not seeking treatment altogether,” said Harriette Scarpero, MD, of Associated Urologists of Nashville (TN, USA). “With the NURO System, I can offer patients another option to restore bladder function and improve quality of life without the side effects of medication. This minimally invasive thera-

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py targets the brain-bladder miscommunication and can help improve quality of life in a meaningful way.”

OAB affects more than 37 million people in the United States alone, with a significant impact on their quality of life due to disrupted social activities, unsettled exercise, and excessive nighttime voiding that affects sleep. Despite this, only 33% of those suffering seek treatment, and as many as 70% stop using their medications within six months, due to intolerable side effects or unsatisfying results.

Image: The NURO minimally invasive percutaneous tibial neuromodulation (PTNM) system (Photo courtesy of Medtronic).

Cancer Patients Who Elect to Die at Home Live Longer erminal cancer patients who choose to die at home live longer than those who choose to die at a hospital, according to a new study. Researchers at the University of Tsukuba (Japan; www. tsukuba.ac.jp), Tohoku University (Japan; www.tohoku.ac.jp), and other institutions across Japan conducted a multicenter, prospective cohort study from September 2012 through April 2014 in 58 specialist palliative care services to explore the potential differences in the survival time of cancer patients dying at home or in a hospital. In all, the study recruited 2,426 patients, of which 2,069 patients were analyzed; 1,582 receiving hospital-based palliative care and 487 receiving home-based palliative care.

The results revealed that eventually, 1,607 patients actually died in a hospital, and 462 patients died at home, with the survival time of patients who died at home significantly longer than the survival time of patients who died in a hospital. The median survival time was 13 days compared to 9 days in the daily prognosis group, and 36 days versus 29 days in the weekly prognosis group. No signif-

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icant difference was found in the months’ prognosis group. The study was published on March 28, 2016, in Cancer.

“Patients and their families tend to worry that home care won’t provide the quality of care that a hospital will.

However, spending the last days or months at home doesn’t necessarily mean life would be shortened,” said lead author Jun Hamano, MD, an assistant professor of internal medicine at the University of Tsukuba. “Patients, families, and clinicians should be reassured that good home hospice care does not shorten patient life, and even may achieve longer survival.”

Most patients with advanced cancer would prefer to die at home, and many people in the United States, United Kingdom, and other countries are realizing this wish. But in other countries, such as Japan, Germany, Greece, and Portugal a trend towards institutionalized dying persists. But despite trends, the most frequent location of death for those dying from cancer is still a hospital, with marked variations in the odds of home death depending on illness-related, individual, and environmental factors.

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Vibration Plate Improves Function in Cerebral Palsy Patients new clinical trial shows that adolescents and young adults with cerebral palsy (CP) enjoy stronger bones and greater mobility after training on a specialized vibration plate.

Researchers at the University of Auckland (New Zealand; www.auckland.ac.nz) and The Children’s Hospital at Westmead (Sydney, Australia; www.schn.health.nsw.gov.au) conducted a clinical trial in 40 participants (11.3–20.8 years of age) with mild to moderate CP to study wholebody vibration training (WBVT) effects on muscle function and bone health. Study participants underwent 20-week WBVT on a vibration plate for 9 minutes a day, 4 times a week. Assessment measures included a six-minute walk test, whole-body dual X-ray absorptiometry (DXA), lower leg peripheral quantitative computed tomography (pQCT) scans, and muscle function.

The patients stood barefoot on a special vibration plate that produced a see-saw movement, stimulating a movement similar to walking. The results showed that the 20 weeks of WBVT were associated with increased lean mass in the total body, trunk, and lower limbs. Bone mineral content and density also increased in the total body, the lumbar spine, and the lower limbs. Participants also im-

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Image: Dr. Silmara Gusso and the WBVT plate (Photo courtesy of the University of Auckland).

proved the distance walked in the 6-minute walk test by 11 to 35%. The study was published on March 3, 2016, in Scientific Reports.

“We expected them to increase their bone mass and muscle mass, which is what happened.

What we didn’t expect was that their day-to-day functioning would also improve,” said lead author Silmara Gusso, PhD. “The feedback from parents and caregivers about the changes they were noticing was especially encouraging: improved mood, greater maneuverability, and fewer falls. In a group with troublesome constipation vibration therapy was also unexpectedly beneficial.”

CP is the most common cause of physical disability in childhood, affecting two of 1,000 children, and usually appears at birth or in early infancy. Children with CP have impaired muscle function, reduced muscle and bone mass, and a higherthan-normal risk of bone fractures. Muscles that normally work in complementary action will simultaneously go into spasm, making movement difficult, and over time the muscles waste. Treatments to relieve the disorders’ effects are limited, and include botox injection, surgery, passive stretching, and injection of bisphosphonates to increase bone density.

New Process Quickly Stops Bleeding from Stab Wounds ew research suggests that that a liquid form of chemical element gallium (Ga) can rapidly halt bleeding from deep wounds, without causing blood clots.

Researchers at Ariel University (Israel; www. ariel.ac.il) have found that Gallium nitrate, the gallium salt of nitric acid, can stop bleeding by inducing flocculation of the clotting protein fibrinogen, resulting in an external clot formation at the site of injury not induced by activating the natural clotting mechanism of the blood. Additional benefits of using gallium nitrate are that it is a powerful anti-infective and speeds up the healing of injuries caused by deep gashes. As such, it could dramatically increase the chances of survival by victims of terror or accidents.

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At this stage, the gallium solution has to undergo further studies to determine the optimal dose and delivery method. In addition, a comparative efficacy trial with other technologies for stopping bleeding needs to be performed. In an experiment conducted to test clotting times, warfarin did not negate or interfere with the blood-stemming property of gallium nitrate.

“Unfortunately, there seems to be no immediate end in sight to the kind of violent attacks facing Israelis; Gallium can provide instantaneous help to victims in Israel. Our goal is to place gallium in every first aid kit and every ambulance, ensuring that every stabbing victim has an increased chance of survival,” said lead author Moshe Rogosnitzky,

PhD. “Moreover, as blood loss remains the leading cause of death from stabbings and other external injuries, it is our hope that this innovation can help innocent victims of violent crime or accidents throughout the world by significantly reducing mortality rate and providing an effective and safe answer for blood loss from wounds.”

Gallium nitrate is predominantly used to treat symptomatic hypercalcemia secondary to cancer.

The postulated mechanism of action is that it prevents the breakdown of bone through the inhibition of osteoclast activity, thus lowering the amount of free calcium in the blood. Gallium nitrate has also been used in the treatment of non-Hodgkin’s lymphoma, multiple myeloma, and Paget’s disease.

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PRODUCT NEWS MRI VENTILATOR

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DEFIBRILLATOR

HEMODIALYSIS MACHINE

Hamilton Medical

Medical Econet

Landwind Medical

The HAMILTON-MR1 features an integrated turbine for independence from compressed air, and a battery for continuous ventilation from the ICU to the scanner without an external power source. It also has an onboard magnetic field navigator for measurement of background magnetic levels.

The ME PAD Automatic provides assistance through voice instructions in 16 different languages, and automatically checks for battery performance and durability of the electrodes. It offers emergency shift to pediatric use without changing pads, and a long-life Li-ion battery.

The JHM-2028 double-pump machine can perform hemodialysis, hemoperfusion, plasma exchange, hemodiafiltration online, and pure UF treatments. It comes with a pyrogen filter port for online hemodiafiltration and net connection function, and a user-friendly touch screen.

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Innovative Blood Draw Device Reduces Patient Discomfort novel blood draw device reduces procedure-related discomfort and anxiety, provides a safer work environment, and standardizes fragmented approaches to inpatient blood draws.

The Velano device attaches to a peripheral intravenous (PIV) catheter to draw blood directly into a vacuum tube or a syringe, thereby reducing the need for additional venipuncture for blood draws.

Available in both 20- and 22-gauge size, the device is comprised of an inner tube with a plunger, a proximal flexible tube with female Luer, and an outer barrel with a male Luer. The male Luer attaches to the PIV system, while the female Luer attaches to a blood transfer device or syringe, from which a blood sample is then collected.

The device is activated by pressing the plunger, which subsequently advances a small polymer cannula through the PIV catheter and into the vessel.

Blood is then drawn using standard vacuum tubes; after the required number of tubes is filled, the plunger is retracted to its resting position, which

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causes the cannula to be removed from the PIV; it is then detached from the PIV line and discarded. The Velano device is a product of Velano Vascular (San Francisco, CA, USA; www.velanovascular.com), and has been approved by the US Food and Drug Administration (FDA).

“A fundamental benefit of this technology is reducing the ‘pin cushion effect,’ in which hospitalized patients are stuck several times daily to obtain blood tests. Oftentimes, the draw procedure is plagued by multiple failed attempts,” said Eric Stone, cofounder and CEO of Velano Vascular. “The FDA’s clearance of this novel technology validates the existing clinical need and will allow us to expedite our efforts to bring this innovation to patients, healthcare providers, and hospitals around the world.”

Blood draw procedures occur 350 million times annually in the United States alone. Almost 28% of adult venipunctures and 44% of pediatric venipunctures draws require more than one stick to success-

fully draw blood, and around 10% of children 3–10 years old must be physically restrained to endure a needle-based blood draw. This creates disruptions for patients and clinicians alike, and is associated with significant direct and indirect costs, with studies suggesting that accidental needle sticks cost hospitals upwards of USD 50 million per year.

Image: The Velano device blood draw device (Photo courtesy of Velano Vascular and WSJ).

Migraine Episodes Linked to Parkinson’s Risk uffering two migraine diagnoses in the space of one year is associated with a greater risk of developing Parkinson’s disease (PD) three years later, according to a new study.

Researchers at National Taiwan University Hospital (Taipei; ntuh.mc.ntu.edu.tw) conducted a longitudinal population-based study involving 41,019 subjects (40–90 years of age) with at least two ambulatory visits with a diagnosis of migraine during the year 2001; the control group consisted of 41,019 migraine-free randomly sampled subjects matched by sex, age, co-morbidity, and socioeconomic data. The researchers then measured PDfree survival rate and estimated the effect of migraine presence on the risk of developing PD. The results showed that during a median 32-

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month follow-up, 148 patients in the migraine group and 101 patients in the non-migraine group were diagnosed with PD, suggesting a statistically significant increase in risk for those with migraine.

The researchers listed several explanations for the results, suggesting that both migraines and PD could be the result of serotonergic and dopaminergic system dysfunction, or that both ailments could arise from dysfunctional iron metabolism in the brain. The study was published on February 6, 2016, in Cephalalgia.

“Since this study is an observational study, it is subject to confounding effects arising from imbalance in clinical characteristics between patients with and without migraine. These findings may highlight the importance of early risk assessment for Parkinson’s disease in migraineurs,” said senior

author Prof. Shin-Liang Pan, MD, PhD. “Future longitudinal studies with neuroimaging and neurologic examinations are needed in order to elucidate the relationship and the underlying pathophysiological mechanism between migraine and Parkinson’s disease.”

Migraine is a debilitating condition characterized by moderate to severe headaches, and is about three times more common in women than in men.

The typical migraine headache is aggravated by routine activity, and is unilateral and pulsating in nature, lasting from 4 to 72 hours. Symptoms include nausea, vomiting, photophobia, and phonophobia.

Approximately one-third of people who suffer from migraine headaches perceive an aura – an unusual visual, olfactory, or other sensory experience that is a sign that the migraine will soon occur.

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Critical Care

Wearable Sensor Could Monitor Dehydration and Fatigue fully integrated electronic system that can continuously monitor multiple sweat chemicals could be incorporated into wristbands and headbands, according to a new study.

The prototype device, developed by researchers at the University of California Berkeley (USA; www.berkeley.edu), consists of a flexible circuit board containing 10 circuit chips connected to five sensors that measure sweat metabolites (glucose and lactate) and electrolytes (sodium and potassium ions), as well as the skin temperature. On contact with sweat, electrical signals from the sensors are read by the circuit chips and adjusted for skin temperature changes. The signals are subsequently transmitted wirelessly to a smartphone app, which syncs the data.

The wearable system can be used to measure the detailed sweat profile of human subjects engaged in prolonged indoor and outdoor physical activities, allowing real-time assessment of their physiological state. Each of the four biochemicals measured can offer an insight on the user’s health and wellbeing. Lactate, for example provides information on muscle fatigue; potassium can provide information on dehydration; sodium indicated blood fluid volumes, and glucose levels help determine fatigue. The study describing the technology was

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published on January 28, 2016, in Nature.

“Human sweat contains physiologically rich information, thus making it an attractive body fluid for noninvasive wearable sensors. However, sweat is complex and it is necessary to measure multiple targets to extract meaningful information about your state of health,” said senior author professor of electrical engineering and computer science Ali Javey, PhD. “In this regard, we have developed a fully integrated system that simultaneously and selectively measures multiple sweat analytes. Our work presents a technology platform for sweatbased health monitors.”

“The idea is to have this thumbs-up or thumbsdown device that will give real-time information; it could provide an alarm that you need to take some medication, or that you’re getting dehydrated and need to drink some water,” concluded Prof. Javey.

“When studying the effects of exercise on human physiology, we typically take blood samples. With this noninvasive technology, someday it may be possible to know what’s going on physiologically without needle sticks or attaching little, disposable cups on you.”

Perspiration is the production of fluids secreted by sweat glands in the skin of mammals. Two types of sweat glands can be found in humans: eccrine glands and apocrine glands. In humans, perspira-

tion is primarily a means of thermoregulation, which is achieved by the water-rich secretion of the eccrine glands, found over much of the body. Although containing mainly water, sweat also has roughly 800 biomarkers, including minerals such as sodium, potassium, calcium, magnesium, and many other trace elements, such as zinc, copper, iron, chromium, and many more.

Image: The sweat sensor in a prototype flexible plastic wristband (Photo courtesy of Wei Gao et al., Nature).

Compassion Fatigue May Be Underestimated by Trauma Teams he challenges facing trauma care providers can put them at risk for compassion fatigue (CF) and burnout, according to a new study.

Researchers at Wesley Medical Center (Wichita, KS, USA; www. wesleymc.com), Wichita State University (KS, USA; , www.wichita. edu), and other institutions conducted a qualitative study using surveys and a focus group to measure CF and burnout syndrome (BOS) in a 12member level 1 trauma team, and allow them to share perceptions of related stress triggers and coping strategies. Participation was voluntary, and informed consent was obtained at the beginning of the session. Participants completed surveys for demographic information, perceived quality of life, and a life stress inventory. Three assessment tools were used.

The results showed that 58.3% of the focus group reported no significant problems, whereas the rest reported mild stress; none reported moderate or major stress. As to the professional quality of life scale (ProQOL; a tool used to measure compassion satisfaction), one third scored a combination of low compassion satis-

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faction and high burnout, and another 25% scored moderate burnout. Interpretation of the results yielded that almost half were identified as at risk of BOS, with 25% being distressed, overwhelmed, or useless in job and classified as high risk due to burnout.

The study was published in the January/February 2016 issue of the Journal of Trauma Nursing.

“Trauma team members may not be as adept at managing work stressors as well as they perceive. In addition, the lack of reference to, or use of, institutional resources for coping may be concerning,” concluded lead author Gina Berg, MD, PhD, and colleagues.

Burnout is characterized by exhaustion, lack of enthusiasm and motivation, feelings of ineffectiveness, and also may have the dimension of frustration or cynicism, and as a result reduced efficacy within the workplace. Occupational burnout is typically and particularly found within human service professions; high levels of burnout are prevalent among social workers, nurses, teachers, lawyers, engineers, physicians, customer service representatives, and police officers.

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Critical Care

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Administering Intravenous UV Light Helps Purify Blood

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novel therapy system administers multiple light wavelengths through a peripheral intravenous (IV) catheter to passing blood

supply.

The UVLrx 1500 system is a light-emitting diode (LED) device that administers concurrent ultravioletA (UVA) and visible light at wavelengths specifically chosen for therapeutic qualities. Red light, for example, has anti-inflammatory and immune systemboosting capabilities, while green is shown to improve red blood cell function; UVA light has a potent antimicrobial effect. Because human skin inhibits light penetration, the system delivers the different wavelengths of light through a standard 20-gauge IV catheter via a proprietary dry light adapter (DLA), which integrates fiber-optic light delivery with a saline drip.

Once an IV site is established, system calibration and setup take a matter of minutes. The patient then sits during a 60-minute treatment, which includes 30 minutes of red and UVA wavelengths, followed by 30 minutes of red and green wavelengths. Indi-

cations include reduction of pain, blood pathogens, and inflammation; immune system modulation; improved adenosine triphosphate (ATP) synthesis; and improved wound healing, blood oxygen transport, and circulation. The UVLrx 1500 system is a product of UVLrx Therapeutics (Oldsmar, FL, USA; www.uvlrx.com), and has received the European Community CE marking of approval.

“With its unique, multi-wavelength therapy system, UVLrx is executing its mission to provide safe and effective therapeutic solutions for a variety of medical issues,” declared the company in a press statement. “For hospitals, outpatient surgery centers, and private practice physicians, the UVLrx Treatment System seamlessly integrates with the standards of care for a variety of indications and conditions.”

UV blood irradiation has been used for over a century to treat bacterial and viral infections, and was awarded a Nobel Prize for treating Lupus. Routinely used in hospitals worldwide, the therapy fell out of prominence in the United States with the ad-

vent of antibiotics in the 1950s. The recent expansion of drug-resistant infections has resulted in the return of blood irradiation as an alternative to pharmaceutical therapies.

Image: The UVLrx 1500 system and DLA (Photo courtesy of UVLrx Therapeutics).

Anticoagulant Reversal Agents Widen AF Treatment Options everal anticoagulant reversal agents under development may eliminate obstacles to the use of novel oral anticoagulants, according to a panel of experts.

Convened at a special session of

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the annual Transcatheter Cardiovascular Therapeutics (TCT) meeting, held during October 2015 in San Francisco (CA, USA), the panel discussed the use of the reversal agents, which can swiftly undo the potent ef-

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fects of anticoagulants during major bleeding episodes or emergency surgery in atrial fibrillation (AF) patients.

Numerous questions abound, including how to assess the efficacy of anticoagulation reversal agents, what doses are needed, and optimal intravenous (IV) administration duration and administration.

Leading the way is idarucizumab, a dabigatran reversal agent; it has been used clinically in both major bleeding patients and in patients undergoing emergency surgery with positive results. Other oral anticoagulant reversal agents currently in development are andexanet alfa, a factor Xa decoy has been shown to rapidly attenuate the anti-factor Xa activity of apixaban, rivaroxaban, edoxaban, and enoxaparin and restore thrombin generation in phase 2 studies in healthy human volunteers; reversal is achieved in less than 5 minutes.

Anither is PER977, a water-soluble small-molecule nonspecific reversal agent for multiple anti-Xa and anti-IIa agents. It is currently in phase one to two trials in healthy human volunteers. It has a rapid onset of action, reversing anticoagulation 5 to 10 minutes after IV administration, as evidenced in edoxaban-treated healthy volunteers. Idarucizumab and andexanet alfa received breakthrough therapy designations from the US Food and Drug Administration (FDA); PER977 has received Fast Track status.

“Reversal agents for new anticoagulants are important because antico-

agulation is still underused as stroke prevention in patients with atrial fibrillation,” said panel member Prof.

Lisa Jennings, PhD, director of the vascular biology center at the University of Tennessee Health Science Center (UTHSC; Memphis, USA; www. uthsc.edu). “Underuse persists, although the new anticoagulants overcome some of the difficulties of anticoagulant provided by the Vitamin K antagonists. Perhaps one reason for the lack of wider uptake is the absence of new anticoagulant reversal agents.”

“There is reluctance among physicians to prescribe new anticoagulant agents because there are no available reversible agents,” added Ajay Kirtane, MD, assistant professor of clinical medicine at Columbia University (New York, NY, USA; www.columbia.edu). “At present we don’t prefer those newer agents because if somebody were to bleed – not that it happens that frequently – then you would not be able to reverse it. If the reversal agents were available, those scenarios would just go away.”

The pending use of the new oral anticoagulants ranges from 23–36 million people in the developed world by the year 2020, and an estimated 500,000 of these are going to need a drug that can rapidly reverse anticoagulation. It is important to note, however, that while both smallmolecule and antibody-based anticoagulant reversal agents are showing promising results, none of these agents are approved for the acute reversal of novel oral anticoagulants.

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Critical Care

Innovative ICDs Automatically Adapt to MRI Settings new line of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization devices (CRT-Ds) can automatically detect MRI environments.

The Biotronik Ilivia ICDs and CRT-Ds feature both ProMRI, a technology that allows patients with a cardiac system to safely access MRI scanning, and MRI AutoDetect, which allows the cardiologist to activate a time window lasting up to 14 days, during which all device functionality is maintained until the patient undergoes the actual scan; at that point the device automatically switches into MRI mode. Once the scan is completed, all device functionality is once again restored automatically, all without the need for the cardiologist’s intervention.

Soon after the scan, the cardiologist receives a full report via Biotronik Home Monitoring, a system designed to replace device interrogation with customizable fully programmable alerts, with options to specify alert thresholds and ranges, and call-back notifications that direct the patient to

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contact the clinic. Other features include MultiPole Pacing (MPP) to improve therapy for CRT patients, a closed loop stimulation (CLS) algorithm for more adaptive pacing, and DX technology for ICDs and CRT-Ds. Biotronik Ilivia ICDs and CRT-Ds are products of Biotronik (Berlin, Germany; www.boitronik.com).

“MRI AutoDetect will not only reduce the amount of time the patient’s device stays in MRI mode, but I expect it will also greatly improve the workflow between the cardiologist and radiologist, which will ultimately benefit our patients,” said Manuel Ortega, senior vice president of Biotronik. “MRI AutoDetect is the next step in ensuring that patients get the full benefit of both their implanted devices and diagnostic imaging.”

“Patients aren’t fully protected if they have an event while their devices are programmed in MRI mode, a period that currently can last a day or more depending on hospital workflows,” said Richard Kobza, MD, head of cardiology at Luzerner Kan-

tonsspital (Lucerne, Switzerland).

“Reducing the amount of time a device is in MRI mode is particularly crucial for ICD and CRT-D patients, and with MRI AutoDetect the only time these patients won’t be able to benefit from full device therapy is the short 30-minute window they spend in the MRI machine itself.”

At present, when a cardiac device patient needs to undergo a MRI scan, a cardiologist must program his or

her device into a special mode that temporarily reduces the device’s functionality until the MRI scan is completed. Following the scan, the cardiologist must switch off the device’s MRI mode to allow the patient to once again have the full therapeutic benefits of their implanted device.

Image: The Ilivia 7 HF-T QP CRT-D with MRI AutoDetect (Photo courtesy of Biotronik).

Statin Use Reduces Cardiac Surgery Complications tatin use both before and after coronary artery bypass grafting (CABG) surgery could reduce complications and risk of death, according to a new study.

Researchers at the Cleveland Clinic (CC; OH, USA; http:// my.clevelandclinic.org) and the University of Florida (UF; Gainesville, USA; www.ufl.edu) conducted a literature review to examine statin use both before and after CABG surgery to evaluate the impact on patient outcomes of continuing or stopping drug use prior to surgery. The researchers reviewed all related articles in the Medline database through July 2015, and weighed the evidence regarding the incidence of statin-related adverse effects in this setting.

The researchers found that statin use prior to CABG surgery may help protect patients from developing atrial fibrillation (AF), a common complication following heart surgery.

Preoperative statin therapy was also independently associated with a lower risk of cardiovascular outcomes at 30 days, including death. Taking statins prior to surgery appeared to be well tolerated by patients, and the

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risk of side effects was low compared to the potential benefits. The researchers could not define what statin dosage is optimal. The study was published on January 12, 2106, in the Annals of Thoracic Surgery.

“The results of our review call for proactive efforts to counsel patients and surgeons about the benefit of statins, a benefit that definitely outweighs the risk of rare potential side effects,” said lead author Amr Baraka, MD, of the Cleveland Clinic.

“Even in patients who were not having heart-based interventions, statins had a positive influence on recovery.”

According to the US Centers for Disease Control and Prevention (CDC; Atlanta, GA, USA; www. cdc.gov), cholesterol-lowering medication is used by 28% of Americans over the age of 40, and statins account for more than 90% of these drugs. But beyond lowering lipid levels, statins also exert a constellation of pleiotropic beneficial effects, which include an anti-inflammatory role. CABG is associated with an intense systemic inflammatory response, which has been linked to postoperative complications.

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PRODUCT NEWS DICOM PRINT SOLUTION

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MEDICAL SHIELDING SYSTEM

MAMMOGRAPHY VIEWER

Aycan

ETS Lindgren

Fujifilm

The XRAY-PRINT is a plain paper print solution that is DICOM 3.0-compatible with PACS. The hardware and software have been optimized for medical images to achieve near-film quality prints, making it ideal for sharing radiological images with patients and referring physicians.

The SAFESCAN automated detection systems provide functional sensitivity to ferromagnetic material and come with both audio and visual indicators. They are ideal for detection in doorways and hallways inside an MRI area, and can be installed into any new or existing MRI suite.

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

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Nitric Oxide Inhalation Device for MRI Procedures Cleared by FDA he US Food and Drug Administration (FDA) have cleared a system for use with neonates that require MRI procedures and a constant concentration of nitric oxide (NO) inhalation therapy gas in the patient-breathing circuit.

The system, provided by a leading specialty biopharmaceutical company, enables continuity of care and uninterrupted nitric oxide for inhalation therapy for neonates, and increases delivery options.

The FDA cleared the Mallinckrodt (St. Louis, MO, USA; www.mallinckrodt.com) INOmax (http://inomax. com) DSIR Plus Magnetic Resonance Imaging (MRI) device for delivery of INOMAX (nitric oxide) during MRI

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procedures only with validated and compatible Magnetic Resonance Conditional ventilators, identified in the device labeling.

The FDA clearance is based on the determination of Substantial Equivalence of the new INOmax DSIR Plus MRI device to the INOmax DSIR. The delivery systems consist of the INOblender delivery system unit, a stand/cart, and INOmax cylinders. The new device features modified cart hardware, delivery cable and tubing, gas sampling tubing, MRI set-up wizard software, and modified labeling, but has the same intended therapeutic effect and is intended for the same patient population as the INOmax DSIR.

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The new device is considered MR Conditional for use with only with 1.5 T and 3.0 T static magnetic field scanners, where the field strength is less than 100 gauss.

Dr. Stephen Welty, professor of pediatrics and leading neonatologist, said, “Neonates being treated with INOmax frequently have multiple medical concerns that may need diagnostic imaging, such as an

MRI scan, to guide medical management. Before INOmax DSIR Plus MRI, physicians had to make the difficult decision to take the risk of interrupting INOmax treatment so that imaging could be done. Now, we can deliver uninterrupted inhaled nitric oxide treatment during diagnostic imaging, which will facilitate clinical decision-making and patient care.”

Retrofit System Assists Upgrade to Digital Radiography n affordable retrofit system allows small to mid-size hospitals, urgent care centers, orthopedic offices, and clinics to upgrade existing rooms or mobile X-ray systems to fully featured digital radiography.

The Carestream Health (Rochester, NY, USA; www.carestream. com) Pro Retrofit System offers a choice of detectors, including gadolinium ones for general radiography imaging or cesium iodide detectors for dose-sensitive applications.

Users have a choice of either wireless or tethered 35 x 43 cm cassettesize detectors that will fit into an existing bucky, or a 43 x 43 cm fixed detector. The detectors are provided with beam-detect mode, which eliminates the need for a cable connection to the generator, and as a result image capture can begin when the detector senses the X-ray exposure.

Enhanced productivity and workflow features include wireless transmission of images to the capture console, immediate image viewing and

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manipulation, and image forwarding to a printer, a picture archiving and communication system (PACS), or to a computer or laptop. Each detector can be identified by a unique access point, or it can be connected to a system control unit that provides continuous signals to one or more detectors. The Pro Retrofit system also includes preloaded Carestream VXvue image management software and an Image Suite mini-PACS module for web-based patient scheduling, image review and reporting, and flexible archiving solutions.

“This flexible retrofit system enables value-based healthcare providers to convert existing X-ray systems to a digital radiography system at a very reasonable cost,” said Sarah Verna, worldwide marketing manager for global X-ray solutions at Carestream. “Facilities across the world can achieve higher image quality and gain rapid image access, which can help enhance patient care and boost productivity.”

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Novel Technology Provides Dynamic Respiratory Imaging nnovative Structured light plethysmography (SLP) imaging technology helps construct a 3-dimensional (3D) image that displays regional breathing correlations and lung symmetry.

The Thora-3Di system projects a structured image that covers the patient’s chest and abdomen to record movement in four dimensions; the recorded image can be replayed in real time, while allowing the clinician to manipulate the view using proprietary SLP software to create a 3D image. The software also provides the operator with the ability to divide the image into defined regions, so as to compare the upper chest and abdomen or the left and right sides of the chest, as a means to identify potential asymmetries indicative of respiratory-related issues.

By comparing the patient’s symmetry of breathing and measuring the chest wall, Thora-3DI can illustrate the dynamics of lung function in real time,

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reflecting respiratory function and providing a deeper understanding of the patient’s lungs, without the need or forced manoeuver testing or moving the patient to a measurement site. The patient can be sitting, lying, conscious, or unconscious, as the Thora3DI is noninvasive and does not require any direct interaction with the patient. Thora-3Di is a product of Pneumacare (Cambridgeshire, United Kingdom; www.pneumacare.com).

“The measurement of lung function changes in children with respiratory diseases is essential if we are to accurately assess the benefit of treatments.

Noninvasive, simple methods have been sought for decades, and the technique developed by Pneumacare is exciting and novel,” said Prof. Warren Lenney, MD, of the University Hospital of North Staffordshire (Stoke on Trent, United Kingdom). “If accurate, reproducible, and sensitive results can be

obtained, I can foresee the technique having wide application in all centers specializing in the management of pediatric respiratory illnesses.”

Image: The Thora-3Di system (Photo courtesy of Pneumacare).

Standard Phantom Developed for Breast Cancer MRI he US National Institute of Standards and Technology (NIST; Gaithersburg, MD, USA; www.nist.gov) has developed a standardized phantom to help test the performance of magnetic resonance imaging (MRI) devices used to identify and monitor breast cancer. The NIST phantom will help standardize and ensure quality control of breast tissue MRIs when comparing images within and between medical research studies, comparing MRI scanner performance, and the training of operators. The phantom is composed of a flexible, soft 15 cm × 12.5 cm silicone shell, with internal components made of rigid polycarbonate to ensure regular geometry. The phantom also supports quantitative MRI, which is increasingly being used for breast cancer diagnosis, staging, and treatment monitoring.

The phantom has two basic types of internal arrangements, which can be paired for MRI scans. One unit, designed for conventional MRI scans, is based on the magnetic properties of hydrogen atoms. It contains four layers of small plastic spheres filled with solutions that mimic tissue, including corn syrup in water to represent fibroglandular tissue, and grapeseed oil to represent fat; the spheres can be customized to meet special clinical needs. Potential options include solutions that would mimic either benign cysts or calcium microcalcifications, which can signal cancer.

The second phantom unit is designed for the newer technique of diffusion MRI, which measures the motion of water molecules within breast tissue. The second unit contains plastic vials filled with varying concentrations of a polyvinylpyrrolidone (PVP), a nontoxic polymer, which is tuned to mimic the differing diffusion properties of malignant and benign tumors. Both units have a modular design to help fit them into different MRI systems. The development process of the new phantom was published on March 6, 2016, in JMRI. “The biggest design challenge was to create a lifelike mimic of both fat and fibroglandular tissue. The design success led to industry’s rapid commercialization of the phantom, currently used by five research groups,” said lead author and NIST project leader Katy Keenan, PhD.

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PRODUCT NEWS TOMOSYNTHESIS SYSTEM

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ULTRASOUND SYSTEM

CT SCANNER

GE Healthcare

Mindray Medical Imaging

Hitachi Aloka Medical

The SenoClaire 3D system uses a low-dose short X-ray sweep around the compressed breast with nine exposures to separate tissues and reduce the overlapping of structures. It delivers high DQE at low dose for visualizing microcalcifications without binning and its images are PACS-compatible.

The TE7 touch-enabled system supports rapid and confident evaluation in multiple point-of-care settings. The intuitive tablet-like operation, superior image quality with one-touch image optimization, and exam presets improve both diagnostic confidence and efficiency.

The SCENARIA scanner features a 0.35-second rotation speed which reduces kinetic artifact, exam time and contrast volume, while maintaining diagnostic imagery. It offers a maximum field of view of 500mm, up to 5660 view/rot high-speed data acquisition and a gantry aperture of 75cm.

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Mathematical Tool Helps Predict Occurrence of Migraines in Concussion Patients esearchers have developed a mathematical tool to help find which concussion patients are most likely to suffer migraines.

The study results were published online in the journal Radiology. Patients with concussion injuries commonly suffer from post-traumatic migraine headaches. To investigate the relationship between headaches and concussion-related damage to the brain, researchers normally use a Magnetic Resonance Imaging (MRI) technique called Diffusion Tensor Imaging (DTI). Researchers create histograms of the whole brain, and then a mean Fractional Anistropy (FA).

There are shortcomings with the FA technique however.

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Instead of using the FA technique, the researchers analyzed the MRI scan results using Shannon entropy, an information theory model that that reveals areas of entropy, in the brain. The researchers then assessed the performance of Shannon entropy for use as a diagnostic tool for concussion patients with and without posttraumatic migraines. The study included 74 concussion patients – 57 with post-traumatic migraines and 17 without, 22 healthy control patients, and 20 control patients with migraine headaches. Mean FA and Shannon entropy results were calculated from the total brain FA histograms and compared between concussion patients and the control patients, and between those patients

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with, and those without post-traumatic migraine.

The results showed that using Shannon entropy analysis of FA histograms was more successful than mean FA as a diagnostic test to differentiate between concussion patients and controls. In addition, Shannon entropy was better in determining

which concussion patients would develop post-traumatic migraines. The results also suggested that Shannon entropy could provide a reproducible biomarker that can be calculated automatically and can help triage patients after initial injury, and predict which patients are more likely to have severe symptoms.

Radiation Risk from Digital Screening Mammography Can Be Reduced Further he risk of radiation-induced breast cancer for women undergoing digital screening mammography can be reduced even more for most women by employing simple changes in screening guidelines.

The findings were published in the January 2016 issue of the Annals of Internal Medicine. The research was part of a comprehensive modeling study, undertaken by the UC Davis School of Medicine (Sacramento, CA, USA; www.ucdmc.ucdavis. edu/medschool) that found minimal risk of radiation-induced breast cancer for most women from digital mammography breast cancer screening.

Women with large breasts or those with breast implants, often receive extra screening, and have increased radiation exposure. Larger detectors and other new technologies can help mitigate the risk for these women.

The researchers modeled the risk of women developing radiation-induced breast cancer during their lifetime from digital screening mammography, and as a result dying from the disease. The researchers compared this to the number of breast cancer deaths that were prevented by early

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detection and found that screening 100,000 women aged between 50 and 74, every two years, prevented 627 deaths. The radiation from such exams, and subsequent additional diagnostics, could cause 27 cases of breast cancer, and four deaths. When women aged 40 to 74 were screened every year, an additional 100 radiation-induced breast cancers occurred, and 12 breast cancer deaths, compared to women aged 50 to 74, who were screened every two years.

The results of the study showed screening mammograms taken every two years, instead of yearly, and starting from age 50, not 40 or 45, would be safer for all women.

Diana Miglioretti, first author of the study, and Biostatistics professor at UC Davis School of Medicine, said, “For most women, the risks are very low. The one group I worry about is women with very large breasts who choose to be screened annually from ages 40 to 74. Most screening mammograms are two views per breast.

Some women with large breasts need more than four views for a complete screening examination, increasing their exposure to ionizing radiation.”

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PRODUCT NEWS MRI SYSTEM

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ULTRASOUND SYSTEM

MAMMOGRAPHY SYSTEM

Mindray Medical Imaging

Siemens Healthineers

Neusoft Medical Systems

The MagSense 360 features Inscan technology consisting of a dual operating mode, which allows scanning inside the shielding and console rooms.

Its Affinity C-shaped magnets provide maximum openness and 330-degree OPEN feature offers more space for MR intervention surgery.

The ACUSON NX3 Elite features a control panel with more user-customizable settings, along with a 10.4-inch high-resolution touch screen for faster selection of imaging protocols. It also features a 220-degree endocavity transducer for expanding the field of view by up to 75%.

The NeuCare Mammo DR is a full-field digital mammography unit that increases exposure precision, and features whole-panel AEC detection for diagnostic precision. It also features automatic exposure and filter mode for optimizing exposure parameters without making manual adjustments.

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Neurological Differences in Children with Sensory Processing Disorder he results of a new study have shown that children (male and female) affected by the Sensory Processing Disorder (SPD) have different brain connectivity than children without SPD. The study used a Magnetic Resonance Imaging (MRI) technique called Diffusion Tensor Imaging (DTI) to study the children, and found that the changes in brain connectivity predicts challenges with tactile and auditory processing.

The researchers from the University of California San Francisco (UCSF; San Francisco, CA, USA; www.ucsf.edu) published the results in the January 26, 2016, issue of the journal Frontiers in Neuroanatomy. The study included 40 right-handed children with SPD, and 41 right-handed children without an SPD diagnosis. The researchers compared white matter tracts in the brain of both

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groups of children. SPD can cause hypersensitivity to sound, touch, and sight, a lack of fine motor skills, attention challenges, and great difficulties with regulating emotions.

The children’s Sensory Profile and Acoustic Index of the Differential Screening Test were characterized, and part of the Sensory Integration Praxis Tests was carried out to measure auditory and tactile processing. The researchers then used DTI to measure the structural connectivity of both groups of children. DTI measures the movement of water molecules in the brain, and maps the structural connections between regions of the brain by visualizing the direction of white matter fibers, and their integrity.

The results showed that the DTI scans were strongly correlated with the direct measurements of tactile and auditory processing during the neurolog-

ical testing. This will allow clinicians to use DTI to calculate sensory challenges, assess patients objectively using quantifiable biomarkers, and provide personalized treatments.

Senior author of the study, Pratik Mukherjee, MD, PhD, professor of radiology, biomedical imaging, and bioengineering at UCSF, said, “By comparing the white matter in the brain of kids with SPD and typically developing kids, we were able to relate them to direct measurements of auditory and tactile function and find strong correlations between the white matter and sensory functioning.

The children with SPD and the typically developing kids form a continuum, with the children with SPD at one extreme and sensory-typical at the other.

This builds on the idea that SPD is a spectrum disorder and for the first time we have direct measurements, rather than solely relying on parent reports.

fMRI Could Help Identify New Painkillers easuring the brain’s neural response to pain using functional magnetic resonance imaging (fMRI) may be a viable tool for evaluating the effectiveness of new pain medications, according to a new study.

Researchers at John Radcliffe Hospital (Oxford, United Kingdom; www.ouh.nhs.uk/hospitals/jr) and Oxford University (United Kingdom; www.oxford.ac.uk) conducted a double blind, randomized study in 24 healthy volunteers on three separate occasions to assess the use of fMRI in obtaining objective outcome measures of drug differentiation. To induce pain, the researchers used capsaicin cream,

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a topical irritant often used to produce similar characteristics of neuropathic pain on subjects’ skin.

Prior to capsaicin cream application, the subjects either received a single dose of gabapentin, which is considered effective and a first line treatment for neuropathic pain; ibuprofen, which is generally not considered an effective treatment for the condition; or a placebo. The researchers then assessed the effect the drugs or placebo had on the brain’s neural response to pain using fMRI, in addition to patientreported pain relief.

The results showed that neural activity was significantly reduced in the subjects who received gabapentin, even with extremely low subject numbers, highlighting the potential for fMRI to make a drug’s effect clear in small cohorts, such as during the early stages of human drug development. This ability could provide a much-needed objective method to collect data that could prevent premature discarding of potentially beneficial therapies.

The study was published in the January 2106 issue of Anesthesiology.

“Chronic pain is a very common condition.

Even the most effective pain medications currently available only provide adequate pain relief, defined as a 50% reduction in pain, in one out of four patients, while some drugs, such as opioids, have significant side effects, including dependence and overuse,” said lead author Vishvarani Wanigasekera, MD, of the University of Oxford. “We believe that neuroimaging techniques, such as fMRI, can provide objective evidence that can be used as outcome measures in early drug development to enhance the efficiency of the drug development process.”

Patient-reported pain relief is the primary outcome measure used in current drug development studies to assess whether medication is effective or not. However, due to their subjective and contextdependent nature, self-reported pain perception and relief are subject to many influences. Due to the low subject population, researchers can also easily miss effective compounds that might work well in the population at large.

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Medical Imaging

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Monitoring Technology Safeguards Patients Undergoing MRI n innovative monitor provides a comprehensive approach for patients undergoing magnetic resonance imaging (MRI) and warns clinicians of severe medical changes.

The Royal Philips (Amsterdam, The Netherlands; www.philips.com) Expression MR400 MRI Patient Monitor provides intensive care unit (ICU)comparable, bedside-quality monitoring in the MRI suite for all patients, including those requiring anesthesia. Vital signs monitored include invasive blood pressure (IBP), pulse, blood oxygen saturation oximetry (SpO2), body and surface temperatures, end-tidal and inspired CO2, and anesthetic agents, including end-tidal and inspired N2O, inspired O2, and total MAC. The monitor also includes advanced electrocardiogram (ECG) monitoring.

The Expression MR400 uses a 15” LED touch screen display with an interface identical to other Philips monitors, making it easier for clinicians to view and respond to patient data; patient warning signals can be prioritized individually to reduce alarm fatigue. Using wireless technology, the monitor connects to an electronic medical record (EMR) and shares information with the Philips IntelliBridge Enterprise system to seamlessly send and re-

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ceive patient information, ensuring that all care team members have access to the same high-quality patient information.

Features include an intuitive touchscreen graphical user interface with large numerics and simultaneous display of up to thirteen parameters, as well as six waveforms and associated values; gating of both digital pulse and analog waveforms; multipriority visual and audible alarm signals, unique alarm flag messages and pulse tones; and an 8-hour battery life and user-replaceable batteries for extended run time. Options include an information portal (IP5) with wireless remote printing.

Strong electromagnetic fields in the MRI suite make it impossible for clinicians to use traditional patient monitors without causing complications with the monitor itself or degradation of the acquired images. The lack of adequate monitoring is particularly problematic for those patients, including children, who require

anesthesia when getting an MRI; without the ability to reliably track key vital signs, clinicians may not know a patient is in distress until it is too late.

Image: The Expression MR400 MRI patient monitor (Photo courtesy of Philips Healthcare).

Imaging Toolkit Helps Identify Brain Tumor Drug Targets combined magnetic resonance imaging (MRI) and ultramicroscopy (UM) toolkit could help study vessel growth as an aid in glioblastoma therapies, according to a new study.

Researchers at the University of Heidelberg, (Germany; www.uni-heidelberg.de), University Medical Center Göttingen (Germany; www.med.uni-goettingen.de), and other institutions have developed a method to study neoangiogenesis in two glioma models that is based on in vivo MRI and correlative ex-vivo UM of cleared whole brains. The technique is based on T2-

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weighted MRI – one of the basic pulse sequences in MRI – with high resolution to allow for substantially more detail than conventional imaging.

First, the researchers performed pre- and postcontrast MRI scans to define the growth of vessels during glioma development in two different mouse models. The researchers then mapped the development of the vessels by dual-color UM of the whole, cleared brains via fluorescent labelling, which helped resolve typical features of neoangiogenesis and tumor cell invasion with a spatial resolution of ~5 μm. The three dimensional (3D) MRI and complimentary UM data sets – dubbed MR-UM – were

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then compared side-by-side.

The researchers also used the toolkit to assess the effects of existing anti-vascular endothelial growth factor (anti-VEGF) treatments or radiation therapy on the vessel compartment within the two glioma models. They found that such treatments are insufficient to halt tumor growth in mice, which mirrors current human studies. According to the researchers, MR-UM could provide a better understanding of the underlying mechanisms of existing treatment, and could help identify novel targets for future drug development. The study was published on February 3, 2016, in the journal eLife.

“Gliomas are highly malignant brain tumors with poor prognosis. Many efforts have been made to develop therapies against the growth of blood vessels and therefore ‘starve’ tumors of their resources, but they are not entirely effective,” said lead author Michael Breckwoldt, PhD, of the University of Heidelberg. “Improved imaging techniques that faithfully show the vessel architecture, including their growth, structure and density, and the effects of treatments in a non-invasive way are therefore needed to inform the development of future clinical trials.”

Neoangiogenesis is a pivotal therapeutic target in glioblastoma, since blood helps transport oxygen, nutrients, hormones, and waste products quickly and efficiently around the body. As tumors are made up of particularly active cells, their growth heavily depends on numerous blood vessels, in such that a fundamental hallmark of tumor progression is that nearby blood vessels form more quickly. Tumor blood vessels also differ in structure from their normal counterparts, for reasons that need to be investigated in more detail.

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Medical Imaging

First Total-Body PET Scanner To Be Introduced in 2017 he development of world’s first total-body positron emission tomography (PET) scanner could change the way cancer and other diseases are diagnosed and treated.

The project, called Explorer, will design and build a PET scanner that images the entire human body simultaneously. To do so, a consortium between the University of California, Davis (UCD; USA; http:// ucdavis.edu), Lawrence Berkeley National Laboratory (LBL; Berkeley, CA, USA; www.lbl.gov), and the University of Pennsylvania (Philadelphia, PA, USA; www.upenn.edu) was formed with the goal of combining the strengths of each contributor to build a scanner that could reduce radiation doses by a factor of 40, and decrease scanning time from 20 minutes today to just 30 seconds.

The LBL contribution is to develop the electronics that will send the data collected by the scanner’s detectors to a computer, which will convert it into a three-dimensional (3D) image of the patient. Since the new PET scanner will have half a million such detectors, the task is incredibly complex. UCD will develop

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a new molecular imaging agent and human-grade radio-labeled peptides for the project, as well as plans and computer simulations for the totalbody scanner.

The University of Pennsylvania team, led by Prof. Joel Karp, PhD, will investigate and improve time-offlight (TOF) PET imaging, and the quality of the reconstructed images, as well as aid in the clinical interpretation of disease. To do so, each major factor affecting system performance, such as the scintillation detector, the calibrations and processing electronics, data correction techniques, and the image reconstruction algorithm, will be studied independently to develop methodologies that are predictive of human ability to identify and quantify activity uptake in lesions.

“We’re developing the electronic interface between the detectors and the computer algorithm – and the electronics for this scanner is an order of magnitude more complicated than what’s been done before,” said LBL project leader William Moses, PhD, of the molecular biophysics and integrated bioimaging division. “But Berkeley Lab has a long history de-

veloping instrumentation for nuclear medical imaging, including PET scanners, and this project is another milestone in our research.”

“The vision of the Explorer project is to solve two fundamental limitations of PET as it is currently practiced. The first is to allow us to see the entire body all at once,” said UC Davis project leader professor of biomedical engineering Simon Cherry, PhD. PET scans are widely used to diagnose and track a variety of diseases, including cancer, because they show how organs function in the body, in contrast to MRI or CT scans, which

mostly show anatomy. Using radioactive tracers that produce a signal from within the body, PET scanners produce a 3D image that is constructed by computers using sophisticated mathematical techniques. The Explorer project will address shortcomings of the current scanning technology, which requires more time and exposes the patient to more radiation because scans are done in 20-cm segments.

Image: An artist’s rendition of the Explorer total body PET scanner (Photo courtesy of Joe Proudman / UC Davis).

Breakthrough Microvascular Imaging Technology Demonstrated At French Radiology Congress new technology significantly improves color Doppler spatial resolution, and sensitivity, enabling the visualization of fast microvascular flows for the first time.

The technology also provides real time, detailed information to physicians, for the diagnosis of cancerous lesions.

The technology, called AngioPLUS – PLanewave UltraSensitive imaging, was developed by SuperSonic Imagine (Aix-en-Provence, France; www.supersonicimagine.com), pioneers of ShearWave Elastography. SuperSonic Imagine plans to implement AngioPLUS on its Aixplorer ultrasound system, to help clinicians diagnose cancerous lesions in lymph nodes, thyroid, liver, and breast, by enabling visualization of microvascularization and vessel flow of the lesions. AngioPLUS is an important addition to existing noninvasive tools for diagnosing cancer.

Another application of AngioPLUS is for the identification of low-grade

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tendon inflammation in musculoskeletal assessments.

The SuperSonic Imagine Aixplorer ultrasound system, together with the UltraFast platform can acquire images 200 times faster than conventional ultrasound systems, and is the only system that can image two types of ultrasound waves. The system can help clinicians visualize, and analyze tissue stiffness reliably, in real-time, to ensure high image quality and shear waves.

Prof. Jean-Michel Correas, vice chairman, Adult Radiology Department, Necker University Hospital (Paris, France), said, “The AngioPLUS technology significantly improves flow sensitivity in color imaging. This innovation allows physicians to quickly and accurately address challenging clinical situations such as characterizing fortuitously discovered focal liver lesions and renal blood flow disturbance. We believe AngioPLUS can help avoid additional imaging or biopsy procedures”.

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PRODUCT NEWS VIDEO LARYNGOSCOPE

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SUCTION DEVICE

SMOKE FILTRATION DEVICE

Infinium Medical

Atmos Medizintechnik

Buffalo Filter

The ClearVue features a compact and ergonomic design, an anti-fog lens, 2MP camera, and reusable blades that offer low cost per patient. The durable device comes with a two-year warranty, a screen reinforced with anti-shatter protection, and a rechargeable battery.

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

The PlumePort ActiV offers controlled management of smoke plume throughout the surgical procedure with flow control dial and one-hand adjustability. It features a built-in fluid trap to manage moisture, and can be attached to standard trocars using readily available suction systems.

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System Treats Pancreatitis Complications cont’d from cover

gastrointestinal (GI) tract. Using endoscopic ultrasound (EUS) guidance, the stent is delivered to adjacent to the pseudocyst pancreatic fluid collections (PFCs) site. After the GI wall has been breached, the stent is used as a translumenal conduit to bridge the intervening tissues into the pseudocyst, draining it directly into the stomach. Once the pseudocyst has drained and decreased in size, the stent is removed.

The stent comes pre-loaded in the delivery system and is available in multiple lumen diameters (15 mm, 10 mm, 8 mm, and 6 mm) and lengths (10 mm, 6 mm, and 4 mm) to ensure a custom fit.

Two large flanges hold the tissue layers together and form a large diameter drainage channel. The stent is fully covered to prevent leakage and to enable easy removal. The Axios stent and delivery system is a product of Boston Scientific Corporation (Natick, MA, USA; www.bostonscientific.

com), and is magnetic resonance imaging (MRI) compatible.

“In our practice, the AXIOS System has improved the endoscopic treatment of PFCs and walled off necrosis. The delivery system has improved our procedural efficiency by reducing procedure time and patient exposure to X-ray imaging,” said Prof. Todd Baron, MD, director of advanced therapeutic endoscopy at the University of North Carolina Hospital (Chapel Hill, USA).

“In addition, we believe that the large diameter stent design is helping to reduce the cost of care by decreasing hospital length of stay and the number of interventions needed to manage this complex disease.”

Pancreatic ducts may become blocked due to gallstones or injury, causing enzymes that normally drain into the small intestine to be released directly into the pancreas, which can cause a pseudocyst PFCs to form. Open surgery for treating PFCs has

been associated with high rates of morbidity and mortality, but endoscopic solutions can offer a less invasive treatment option associated with shorter hospital stays, better physical and mental health of patients, and lower cost.

Image: The AXIOS stent and electrocautery enhanced delivery system (Photo courtesy of Boston Scientific).

Iliac Branch System Helps Control Aneurysms cont’d from cover

blood flow, and preserve blood flow in the external iliac and internal iliac arteries. The device is made of durable expanded polytetrafluoroethylene (ePTFE) graft material and a nitinol stent, similar to the AAA Endoprosthesis.

The IBE device offers a wide internal iliac artery treatment range of 6.5 to 13.5 mm, and is repositionable to precisely place the iliac component. It is installed using a delivery catheter and 16 French introducer sheath in the case of the iliac branch component, and a 12 French introducer sheath in the case of the internal iliac component. The Gore Excluder IBE is a product of Gore Medical Products (Flagstaff, AZ, USA; www.goremedical.com), and has been approved by the US Food and Drug Administration (FDA).

“The Gore Excluder iliac branch device has

demonstrated high patency, conformability, and durability, and provides physicians with an on-label, minimally invasive method of preserving flow to the internal and external iliac arteries,” said Ryan Takeuchi, aortic business leader at Gore Medical Products (Flagstaff, AZ, USA; www.goremedical. com). “Not only is IBE the first off-the-shelf aortic branch device approved in the United States, it is a part of a complete portfolio of aortic branch solutions that are currently in clinical evaluation.”

“Historically, options to preserve flow to the internal iliac arteries during endovascular aneurysm repair were very limited, despite the involvement of the iliac arteries in about 25% of AAA cases,” said Darren Schneider, MD, chief of vascular and endovascular surgery at Weill Cornell Medical College (New York, NY, USA; www.med.cornell.edu).

“Through our research and the subsequent FDA ap-

proval, physicians now have a new therapeutic option to preserve pelvic perfusion in order to improve clinical outcomes and maintain patient quality of life.”

Preservation of blood flow in the internal iliac arteries avoids pelvic flow disruption and reduces the rate of buttock claudication, sexual dysfunction, and colonic ischemia.

Image: The Gore Excluder Iliac Branch Endoprosthesis (Photo courtesy of Gore Medical Products).

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3D-Printed Titanium Implant Advances Hip Revision Surgery n innovative, entirely porous implant mimics the structure of natural cancellous bone, allowing bone ingrowth to secure the implant in place. The REDAPT revision acetabular fully porous cup is designed for revision cases where compromised bone makes implant fixation and stability more difficult, thus requiring the use of an uncemented cup that allows bone ingrowth. To allow that ingrowth, an additive titanium manufacturing process is used to produce an alternative to external porous coatings, such as the sintered beads or fiber mesh used in other uncemented implants. The additive process results in an entirely porous implant that mimics the natural architecture of human bone.

The cup is also supplied for use with new variable-angle locking screws that can be used to enhance implant stability and minimize micro-motion after surgery. The screws work within the implant’s unique geometry to provide both compression and a rigid construct to the acetabular shell. The cup can also be used with traditional, non-locking screws. The REDAPT revision acetabular fully porous cup is a product of Smith & Nephew (London, United Kingdom; www.smith-nephew.com), and has been approved by the US Food and Drug Administration (FDA).

“We’re excited about the creative possibilities this new manufacturing process holds for surgeons and their patients,” said Mike Donoghue, vice president of global reconstruction at Smith & Nephew. “Bringing to market a 3D-printed titanium acetabular cup for difficult revision procedures is just one example of the potential of this remarkable technology.”

“This fully porous cup gives surgeons flexibility in ways that simply weren’t possible before. This cup builds on good technology and turns it into something spectacular,” said orthopedic surgeon Prof.

Craig Della Valle, MD, of Rush University Medical Center (Chicago, IL, USA), who participated in the surgeon design team of the new REDAPT cup. “The locking screws, screw-in trials, purpose-built liners and screw hole patterns optimized for hard-to-access areas really set it apart during a revision procedure.”

The CONCELOC technology used to build the REDAPT Cup begins by precisely aiming a laser onto a thin layer of titanium (Ti-6Al-4V) powder. The heat generated by the laser fuses the powder together, layer-by-layer, until a fully formed titanium construct is produced. The manufacturing process allows for complex design geometries that would be difficult, expensive, or impossible to achieve with traditional manufacturing methods. For example, solid reinforcements can be built directly into the porous structure to provide extra strength in precise locations.

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Image: The REDAPT revision acetabular fully porous cup (Photo courtesy of Smith & Nephew).

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Surgical Techniques

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Ventricular Assist Technology Supports Cardiac Patients n advanced left ventricular assist system (LVAS) supports the management of patients with advanced stage heart failure (HF). The HeartMate 3 LVAS is a novel centrifugal-flow left ventricular assist device (LVAD) that utilizing fully magnetically levitated (MagLev) technology to reduce trauma to blood passing through the pump and improve outcomes. The LVAS includes a centrifugal blood pump that is implanted above the diaphragm (immediately next to the native heart), attached to the aorta, thus leaving natural circulation in place while providing all of the energy necessary to propel blood throughout the body; the device can pump up to 10 liters of blood per minute.

Features of the device include large, consistent blood flow gaps over a wide range of operation levels; this artificial pulse technology is designed to further reduce adverse patient events, including combating the formation of thrombus in the device.

The patient himself wears an exter-

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nal, wearable controller and battery system to power the pump. The HeartMate 3 LVAS is a product of St. Jude Medical (SJM; St. Paul, MN, USA; www.sjm.com), and is intended as a cardiac support option for advanced HF patients who are awaiting transplantation, are not candidates for transplantation, or are in myocardial recovery.

“The HeartMate 3 shows high survival rates, material improvements in functional status, and very low adverse event rates highlighted by zero pump thrombosis events,” said Eric Fain, MD, group president at SJM. “Heart failure remains one of the most costly epidemic diseases in the world, and the HeartMate 3 system is critical to supporting physicians managing the care of patients battling such a complex and challenging condition.”

“The advanced heart failure medical community has eagerly anticipated the expected clinical improvements with the HeartMate 3 system, and looks forward to its broad adoption throughout Europe,” said Prof.

Friedhelm Beyersdorf, MD, medical director of cardiovascular surgery at Heart Center Freiburg University (Germany), commenting on the European Community (CE) marking of approval for the HeartMate 3 LVAS. An LVAD does not replace the heart, but is intended to complement a weakened heart to provide circulatory support. Surgically implanted in

proximity to the heart, one end is attached to the left ventricle, while the other is attached to the aorta. Blood flows from the ventricles into the pump and is then ejected out of the device and into the aorta.

Image: The HeartMate 3 left ventricular assist system (Photo courtesy of St. Jude Medical).

Noninvasive System Helps Monitor Labor Progress n integrated maternal-fetal monitor provides a wireless solution for accurate monitoring of both uterine contractions and fetal heart rate.

The TrueLabor system is based on an electrical uterine monitor (EUM) that measures electrical activity via surface electromyography (sEMG) electrodes attached to the abdomen to measure the minute electrical signals of uterine contractions and fetal heart beats, allowing expectant mothers to move about the delivery room freely. The location of the electrodes is determined using a position sensor and the signals analyzed by an algorithm. Signal acquisition is unaffected by body movement and coughing, resulting in high quality, reliable information on the activity of the uterus.

The algorithm generates a wave pattern that graphically demonstrates the presence, frequency, and intensity of uterine contractions. Both EUM technology and the algorithm have been shown to be reliable, reproducible, and free of limitations throughout the stages of pregnancy and labor, even when monitoring preterm uterine contractions and in

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high body mass index (BMI) or obese patients. The TrueLabor system is a product of OB-Tools (Migdal Haemek, Israel; www.ob-tools.com), and is designed to work with any current monitoring system and electronic medical record (EMR) systems.

“The algorithm not only highlights the important uterine contraction information but also filters out the excess noise in the body that sometimes interferes with other monitors,” said Gal Ben-David, PhD, MBA, CEO of OB-Tools. “More importantly, our device can distinguish between true and false contraction and is not affected by movement, change of position, coughing, etc.”

EMG is an electro-diagnostic medical technique for evaluating and recording the electrical potential generated by muscle cells when electrically or neurologically activated.

For evaluating uterine contraction activity, the EUM uses nine surface electrodes and a multichannel amplifier to measure sEMG activity. Various studies have shown it to be comparable to traditional monitoring with an intrauterine pressure catheter (IUPC).

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Surgical Techniques

Cardiac Assist System Protects Against Cardiogenic Shock n innovative synchronized cardiac assist system overlays an artificial heartbeat over a natural weakened heartbeat, thus providing a direct cardiac-assist modality.

The XENIOS i-cor synchronized cardiac assist system uses a miniaturized pump to provide physiological beat-to-beat cardiac assist and concomitant synchronized electrocardiogram (ECG)-triggered pulses that are superimposed over the patient’s weakened heartbeats. The combined myocardial protection and organ perfusion assist the weakened heart to significantly improve coronary blood flow and limit after load, when compared with conventional methods.

The system is designed to be a less invasive, more physiological treatment that helps preserve endothelial function and ensure ade-

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quate tissue perfusion, which is essential to maintain individual organ function and prevent multi-organ failure. The oxygenating power of the i-cor is also designed to offer physiological circulatory support, protection, and safety during interventions in the cardiac cath lab, as well as for the management of cardiogenic shock in the intensive care unit (ICU). The i-cor Synchronized Cardiac Assist System is a product of XENIOS (Heilbronn, Germany; www.xenios-ag.com).

“The i-cor system is the world’s first to synchronize mechanical circulatory support with the patient’s weakened heartbeat. We are able to superimpose or overlay an artificial heartbeat over each weakened heartbeat,” said Georg Matheis, MD, managing director of XENIOS. “This advance not only makes possible new

Breast Density Not Linked to Cancer Incidence new study suggests that breast density may not actually be a strong predictor of cancer risk after all.

Researchers at Health Center Osijek (Croatia; www.kbco.hr) conducted a retrospective study involving 52,962 mammography exams performed in women aged 50–69 over a period of five years at five different mammography facilities in the vicinity of Osijek (Croatia). Two radiologists read the mammograms independently and determined breast density according to standard criteria.

The researchers then compared data between patients in the low-density breast tissue group and the high-density group.

The researchers found that the majority of screened women had low breast density. Of the 230 women with detected breast cancers, almost half were from the group with the lowest-ranked breast density, while slightly less than 3% came from women in the highest breast density category. When the researchers matched the women who had a detected cancer with control participants of the same age and from the same locales that did not have cancer, they found no significant difference in mammographic density.

Women with low mammographic density made up 83% of the patients in the breast cancer group, compared

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with 89% in the control group, while high mammographic density was found in 17% of the breast cancer patients and 11% of women in the control group. The study also failed to find a strong association between higher mammographic densities and a higher risk of breast cancer among postmenopausal women. The study was presented at the Radiological Society of North America (RSNA) annual meeting, held during November-December 2015 in Chicago (IL, USA).

“We wanted to find out if breast cancer patients had more dense breast tissue than the healthy women. Also, we wanted to see what the percentage of dense breasts was in our postmenopausal population and, consequently, determine the value of mammography screening for this group,” said lead author and study presenter Natasa Katavic, MD, of the department of radiology. “We found that there was no significant difference in breast density between breast cancer patients and the control group in the screening program.”

Prior research has suggested an association between breast density and breast cancer; in addition, cancers in dense breast tissue are more difficult to see on mammograms. As a result, some women with dense breasts are advised to get supplementary screening with ultrasound or magnetic resonance imaging (MRI).

Image: The i-cor synchronized cardiac assist system (Photo courtesy of XENIOS)

therapy options for patients who are suffering from cardiogenic shock, but also is designed to bridge patients across high-risk interventions in the cardiac cath lab.”

“Patients with cardiogenic shock have a very high mortality rate; in fact, cardiogenic shock as the result of a heart attack is a medical emergency, resulting from an inadequate circulation of blood due to primary

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failure of the heart ventricles to function effectively,” said Juergen Boehm, MD, managing director of XENIOS. “As this is a type of circulatory shock, there is insufficient perfusion of tissue to meet the demands for oxygen.

We are pleased that interventionists will now have a powerful new treatment with which to reduce morbidity and mortality from cardiogenic shock or high-risk interventions.”

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PRODUCT NEWS BOOM APPLIANCE

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ENDOSCOPIC CANNULA

SHOULDER PULL SYSTEM

CV Medical

MedGyn

Samarit Medical

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

The endoscopic (hysteroscopic) cannula is a sterile, single-use and water-resistant device featuring an optical system with suction tube. It is designed for use in cases of abnormal uterine bleeding, infertility, uterine fibroids, suspected uterine/cervical cancer, miscarriages and uterine malformations.

The Shoulder Pull System is used to quickly and safely place a shoulder retainer on a patient undergoing cervical decompression surgery, and can be adjusted for patient size. It is easy to clean, and does not cause any retention, tension blisters, pressure sores or traction.

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Self-Anchoring Aortic Valve Reduces Open Heart Surgery Time n innovative sutureless aortic valve reduces surgical time for both isolated and complex aortic valve replacement procedures, with cross-clamp times typically reduced by at least 50%.

The Perceval aortic valve is intended for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves when performing an open surgical procedure. The valve is made of bovine pericardium, and is mounted on a super-elastic self-anchoring alloy frame. This enables the surgeon to replace the diseased valve without the need for sutures to secure it on place, thus significantly reducing the time spent in open-heart surgery and minimizes the risk for thromboembolic stroke or iatrogenic aortic dissection.

Among the features of the Perceval are a reduced collapsed profile, which prevents trauma to the aortic wall and enables a full and direct view; precise positioning thanks to temporary sutures that guide the valve along the annulus axis, even in narrow spaces; adaptive movement in rhythm with the cardiac cy-

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cle; and, thanks to the absence of a suturing ring, the geometric orifice area is maximized, providing excellent hemodynamics with stable results over time.

The Perceval aortic valve is a product of LivaNova (London, United Kingdom; www.livanova.com), and has been approved by the US Food and Drug Administration (FDA).

“We are excited to bring this important product to the US market, which will provide real value to patients and physicians,” said André-Michel Ballester, CEO of LivaNova. “The rapid acceptance of Perceval in Europe, an increasing number of positive publications on the product, and the solid preparation of our US sales team, all provide a strong base for the achievement of our short and long term plans.”

The company is hoping the device can overcome the rising trend toward implantation of transcatheter aortic valve replacement (TAVR), a procedure that enables the placement of a balloon expandable aortic heart valve into the body via a catheter-based trans-

femoral delivery system. It is designed to provide an alternative treatment to patients in whom traditional open-heart surgery cannot be performed.

Image: The Perceval sutureless aortic valve (Photo courtesy of LivaNova).

Tissue-Based Heart Valves Better for the Middle-Aged atients between 40 and 70 years of age who undergo aortic valve replacement (AVR) may fare better with tissue-based valves rather than metal-based ones, according to a new study. Researchers at the University of Sydney (Australia; http://sydney.edu.au) and Royal Prince Alfred Hospital (Sydney, Australia; www.slhd. nsw.gov.au/rpa) conducted a database search and identified 13 studies comparing mechanical and bioprosthetic valves in AVR patients aged 40 to 70 years. The results revealed that 15-years post-surgery, no difference was found in survival, stroke rate, or rate of endocarditis among patients with either valve; however, each patient group developed a different set of complications.

Patients with bioprosthetic valves were twice as likely as mechanical valve patients to need re-operation due to worn-out valves, while patients with

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mechanical valves were twice as likely to experience a major bleeding event or a blood clot. Because patients with major bleeding had a significant increase of death compared to those needing reoperation, the researchers concluded that bioprosthetic valves should strongly be considered for patients in this age group, though valve choice should be individualized for each patient. The study was published on January 12, 2016, in the Annals of Thoracic Surgery.

“We combined the best available evidence comparing mechanical valves versus bioprosthetic valves to determine the risks and benefits to patients following surgery, depending on the type of valve they received,” said lead author James Wu, BMusStudies, of the University of Sydney. “We hope that our results can give future patients needing AVR more information to help them choose the

appropriate replacement valve for their condition.”

“This is a complex decision that requires up-todate evidence. There are options to reduce the bleeding risk of mechanical valves, so, ideally, a discussion with both the surgeon and cardiologist is warranted to take into account an individual’s circumstances,” concluded senior author Paul Bannon, MBBS, PhD. Mechanical valves are the most long-lasting type of replacement valve, but patients will usually require blood thinners to stop clots from forming, as they can lodge in valve flaps or hinges which can cause a malfunction or form emboli. Bioprosthetic tissue can last 10–20 years, but usually do not require long-term use of medication. On the other hand, a young person with a bioprosthetic valve replacement, the need for additional surgery or another valve replacement later in life is highly likely.

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Surgical Techniques

Intelligent Socks Help Reduce Diabetic Foot Ulcers nnovative pressure-sensing socks linked to a smart phone application help warn diabetics of impending wounds.

Under development by BioDesign researchers at the Hebrew University (HUJI; Jerusalem, Israel; www. huji.ac.il) and Hadassah Medical Center (Jerusalem, Israel; www. hadassah-med.com), SenseGO socks were developed to warn patients of incorrect posture that can lead to excessive pressure on sensitive parts of the foot. Failure to treat these issues in a timely fashion could eventually lead to foot ulcers, sores, or wounds that refuse to heal, a special problem for diabetics, whose ability to heal themselves is already compromised because of their blood circulation problems.

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The socks contain dozens of micro-fabricated pressure sensors that measure changes in pressure due to an incorrect stance, anatomical deformation, or ill-fitting shoes. The pressure readings are registered as electrical signals that are relayed to a smartphone app, which in turn informs the patient of a developing risk and that they need to improve their posture. The socks, which are machine-washable thanks to novel materials technology, could help temper the effects of diabetic neuropathy by offering a “sensor assist” to the feet.

“With the SenseGo, patients and their families get the tools they need to prevent the development of foot ulcers. Thus we can dramatically reduce health care costs related to dia-

Capsule Reconstruction Restores Large Rotator Cuff Tears n innovative arthroscopic graft procedure for treating massive rotator cuff tears may help patients return to sports and work quicker.

Researchers at Osaka Medical College (Japan; www.osaka-med.ac.jp/ Global/2-index.html) followed 100 patients (average age 66 years) who underwent arthroscopic superior capsule reconstruction (ASCR) for irreparable rotator cuff tears between 2007 and 2014; all patients had failed previous surgical treatment.

Physical exams, X-rays, and magnetic resonance imaging (MRI) were performed prior to surgery and also again at 3, 6, 12 months, and yearly thereafter. Return to sport and work rates were also analyzed in 34 patients who were employed and 26 patients who were recreational athletes prior to injury.

The results showed an average

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postoperative outcome score of 92%, with significantly improved strength and shoulder function. Thirty-two of 34 patients returned fully to their previous work, with the other two patients returning with reduced hours and workloads. All 26 patients who played sports prior to injury also returned fully to their activities. The study was presented at the American Orthopedic Society for Sports Medicine (AOSSM) specialty day, held during March 2016 in Orlando (FL, USA).

“Arthroscopic superior capsule reconstruction restored shoulder function at a greater rate than previous forms of treatment, and helped return our patients to recreational sport and work faster,” said lead author Teruhisa Mihata, MD, PhD. “Our positive results suggest that this procedure is a viable option for irreparable, large rotator cuff tears. We hope to perform additional research to further solidify our results.”

ASCR involves using a fascia lata – the deep fascia of the thigh – tissue graft attached medially to the superior tubercle of the glenoid and laterally to the greater tuberosity, with concomitant arthroscopic repair of the torn subscapularis tendon. Side-to-side sutures are then added between the graft and the infraspinatus tendon and between the graft and the subscapularis tendon to improve force coupling in the shoulder joint.

betes,” said Prof. Yaakov Nahmias, PhD, director of the HUJI BioDesign center for bioengineering. “The novelty of our technology is the 3D organization of the sensors, which is important for clinical problems where the foot deforms over time.

This is a classic mobile health approach to reduce health costs.”

Diabetic neuropathy is a type of nerve damage associated with the development of foot ulcers in patients

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with diabetes. Resulting from anatomical deformation, excessive pressure, and poor blood supply, it affects over 130 million individuals worldwide. It is also the leading cause of amputation, costing the United States economy alone more than USD 10 billion annually.

Image: The concept design of the pressure-sensing socks (Photo courtesy of HUJI).

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PRODUCT NEWS MOBILE C-ARM

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ENDOSCOPY SYSTEM

ELECTROSURGICAL ANALYZER

General Medical Merate

PENTAX Medical

Fluke Biomedical

The SYMBOL offers a 146-degree orbital movement with a 56-degree overscan for flexible, precise and rapid positioning. It allows for selection of the best projection for procedures in general and endovascular surgery, neurosurgery, gastroenterology, cardiology, urology and orthopedics.

The DEFINA features an HD processor and i-scan technology for precise detection/demarcation of suspicious areas, and characterization of abnormalities. It has two HD bronchoscopes, angulation levers, and remote control buttons for effortless maneuverability within the bronchus.

The QA-ES III tests all ESU functions, including precision power, current, frequency, crest factor, and load resistance. Its multi-purpose ports, coupled with its color-coded stacking leads, minimize the number of connections necessary to test and verify the performance and safety of ESUs.

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Waste Fill Sensor Monitors Ostomy Bags

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novel sensor and app for remote monitoring of ostomy pouches helps patients and caregivers remain aware when the external pouch is filling up with bodily waste.

The Ostom-i Alert monitors clips to the outside of most ostomy pouches, measuring fullness by sensing the arc of the bag’s external curvature. Data is communicated to both Apple and Android smart- Image: The Ostom-i bag fill phones via Bluetooth connec- sensor by 11 Health tivity to a mobile app, which approved by the US Food and Drug warns the patient when the bag is Administration (FDA). close to being full. There is also a “The aim is to enable patients to tablet app designed for hospital use to better self-manage and healthcare promanage multiple ostomy patients at fessionals can, for the first time, reone time. The device can also be promote monitor them,” said Michael grammed by the user to set multiple Seres, president of 11 Health, who dealarms, and alert them to when their veloped the sensor after undergoing a pouch is filling for up to three months. small bowel transplant. “This can lead For example, fill levels change deto early intervention to prevent issues pending on the users’ body position like dehydration and electrolyte loss over extended periods of time. Thus, that often results in readmissions.” when the patient is lying down, the An ostomy bag provides a means ostomy bag may appear to be less full for the collection of waste output from than it is when the patient is standing a stoma created during colostomies, up. By setting alarm limits to a lower ileostomies, and urostomies. The bags level, unwanted overflows and leaks allow the stoma to drain into a sealed causing embarrassment to the patient collection pouch via a baseplate, while and caregivers can be avoided. Data protecting the surrounding skin. For streaming is continuous, so that maximum hygiene and to reduce risk healthcare professionals and careof infection via contamination, the bag givers can follow real-time trends. Osshould be changed every 24 hours, tomy volume output data is also availunless the bags are re-sealable. Ostoable on the company’s website. The my bags are air- and watertight, allowOstom-i Alert is a product of 11 ing the wearer to lead an active Health (London, United Kingdom; lifestyle. www.11health.com), and has been

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Management Solution Helps Hospitals Control Assets

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new asset lifecycle management solution helps hospitals integrate and simplify their information technology (IT) portfolio while complying with regulatory guidelines.

The Ricoh Symphion Asset Lifecycle Management for Healthcare offering is an information-as-a-service software solution that tracks hardware and software issues on a hospital’s IT network, simplifying the management of print and other managed devices while helping to identify compliance risks. A software toolset features automated scanning, device discovery, and predictive analytics to help hospital IT management make informed decisions that can help reduce device, labor, and other costs, while at the same time manage the risks of ever-evolving infrastructure.

Features include agentless asset scanning, which identifies and reports hardware and software issues on a hospital’s network, making redundant the manual confirmation process. A systematic, enterprise-wide assessment process collects and analyzes information on print assets and service, IT inventories, configurations, and operations and vulnerabilities in a Windows platform to help reduce system downtime. Reporting on and management of print devices and analysis of print costs, usage, and uptime trends help optimize print processes and reduce costs.

Streamlined and automated reporting NE on software titles help ensure only softDES W IGN ware that is needed and being used is ordered or gets a license extension, which can help reduce compliance risk and overall IT spending for the hospital. The solution also provides support for the WORLD’S MEDICAL PRODUCT MARKETPLACE technology via a dedicated “concierge team” of experts who deliver services for the term of the contract as an extension of the provider’s team. The Ricoh Symphion Asset Lifecycle Management for SIGN UP Healthcare is a product of Ricoh (Tokyo, FOR FREE! Japan; www.ricoh.com) and Symphion (Dallas, TX, USA; www.symphion.com).

“At its core, the healthcare industry serves to protect the most vulnerable from harm. For Ricoh this means protecting patients’ private information and helping to ensure that our customers have security safeguards in place,” said Ron Nielson, vice president of healthcare at Ricoh Americas Corporation. “With our Asset Lifecycle Management for Healthcare, hospitals are now equipped with enterprise-wide, constantly updated information about their hardware and software assets to make quick and accurate decisions to keep their technology in good health.”

Hospitals are challenged with improving efficiencies and reducing costs, while striving at the same time to comply with Health Insurance Portability and Accountability Act (HIPAA) mandates and meanConnecting Buyers with ingful use of Electronic Health Records (EHRs). The ability to seamlessly capture, Suppliers Worldwide transform, and manage patient and busiReach new sources of supply ness data across departments with secure Identify latest products and technologies IT ecosystems can improve care coordinaSend inquiries directly to suppliers tion and clinical processes, driving busiReceive latest product alerts ness efficiencies, profitability, and meanChat live with suppliers ingful use.

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Image: The Asset Lifecycle Management for Healthcare software solution tracks hardware and software issues on a hospital’s IT network (Photo courtesy of Ricoh).

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TradeMed provides a sophisticated yet easy-to-use global B2B platform for sourcing medical equipment. TradeMed connects buyers and sellers worldwide through a safe, secure and dynamic network. Solely dedicated to medical products, TradeMed is the premier choice for medical suppliers, hospital decisionmakers and buyers worldwide, regardless of size or budget.

PRODUCT NEWS PATIENT MONITOR

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MEDICAL DIAGNOSTIC DISPLAY

MEDICAL DISPLAY MONITOR

Mortara Instruments

NEC Display Solutions

Totoku

The Surveyor Central enables continuous 12-lead ECG monitoring/trending using the VERITAS ECG algorithm with the S12/S19 monitors, X12+/T12S transmitters or Surveyor S4 monitor. Measurements and interpretation are automatically printed/exported to a data management system.

The MDC212C2 is a clinical desktop display with a 21.3-inch 2MP IPS panel that provides precise color or grayscale reproduction and wide viewing angles. An integrated front sensor constantly monitors and adjusts brightness to maintain the factory DICOM GSDF calibration.

The CCL550i2 is a 5MP medical display color monitor that can accommodate images from ultrasound, CT, MRI, pathology and digital mammography on a single screen. It automatically recognizes color images to provide optimized contrast, brightness, and gamma without user intervention.

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GE HealthCloud to Receive Radiology Protocols Tool adiology Protocols (Iowa City, IA, USA; www.radiologyprotocols.com) has announced that its protocol management tool for medical imaging devices will be added to the GE Healthcare (GE; Little Chalfont, United Kingdom; www.gehealthcare.com) HealthCloud suite of applications when the Cloud goes live in late 2016.

Radiology Protocols offers an intuitive online radiology imaging management platform that provides a customizable, scalable, Health Insurance Portability and Accountability Act (HIPAA)-secure hosted solution to document, organize, and tailor imaging protocols. The protocol management tool is vendor agnostic, allowing customers to utilize the system across different equipment modalities and different platforms to allow providers to share best practices across systems instantaneously and seamlessly, thus eliminating paper-based files.

The standardized imaging guidelines conform to both the local imaging practices and the regulatory environment, based on a hosted system that improves communication, saves time and money, and improves patient care. Under the agreement, GE

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HealthCloud radiology department customers will be able to access and use the sophisticated protocol management platform to increase productivity and improve the quality of exams.

“Radiology Protocols is pleased to take its place as one of the GE HealthCloud’s early and core applications which will enable exceptional connectivity and scalability for customers,” said Stephen Baker, founder and president of Radiology Protocols. “This will allow for standardization of imaging protocols across IDN’s resulting in better utilization, sharing of best practices and improved patient care.”

“Radiology Protocols delivers much needed quality improvement tool that imaging customers around the world need; a method to define, organize and maintain imaging protocols, for all modality types, on a centralized, web-based platform,” said John Kalafut, imaging outcomes and solutions leader at GE Healthcare. “As a vendor agnostic system, it can be used to manage the protocol process by all of our customers, which is a great advantage for everyone.”

GE HealthCloud, which includes a suite of enterprise imaging applications, provides a robust platform

for software vendors to deliver healthcare applications across the healthcare enterprise including large, complex integrated delivery networks (IDNs).

Image: The GE HealthCloud will receive a protocol management tool from Radiology Protocols in late 2016 (Photo courtesy of GE Healthcare).

First-of-Its-Kind Neurosurgery Visualization Platform novel neurosurgery Virtual Reality (VR) visualization platform has been demonstrated at the NVIDIA GPU Technology Conference (GTC) 2016 in California (USA).

The enterprise-wide solution is intended to help clinicians plan, prepare, and perform neurosurgery, and enable the surgeon to empower and engage their patients throughout the care cycle, from the examination room, to the operating room.

The platform was developed by Surgical Theater (Mayfield Village, Ohio, USA; www.surgical theater.net), a world leader in medical virtual reality systems. The platform includes NVIDIA (Santa Clara, CA, USA; www.nvidia.com) Graphics Processing Units (GPU) also used in VR gaming, flight

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simulation, and artificial intelligence. The Surgical Theater platform combines data from different imaging modalities including Magnetic Resonance Imaging (MRI) and Computed Tomography (CT) to build a virtual reconstruction of a patients’ anatomy.

The user of the new platform wears an HTC (Xindian; New Taipei City, Taiwan; www.htc.com) Vive VR headset, and can perform a VR “fly through” of a patient’s anatomy, before and during the operation. This enables the neurosurgeon to navigate the unique anatomy of each patient and treat neurological disorders, and cerebrovascular diseases. The platform enables the neurosurgeon to show the patient the planned surgery in VR, and

helps them understand the procedure.

Dr. Neil Martin, chairman of the University of California, Los Angeles (UCLA; Los Angeles, CA, USA; www.ucla.edu) Department of Neurosurgery, said, “Surgical Theater provides an immersive and memorable situational awareness when navigating through the inner space of the patient’s brain. Flying through the patient’s brain and having the ability to circumnavigate the tumor to see how the surrounding tissue, arteries or the optic nerve could be connected is critical to planning the removal procedure. It stays with you. So the terrain of the patient’s brain is familiar in surgery, which can enhance performance, reduce risk, and improve the overall outcome and timing of the surgery.”

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Health IT

Enterprise Content Management Provider Announces New Services and US FDA Clearance of DICOM Image Viewer leading enterprise content management provider has announced several new offerings, including a new solution to help hospitals make the digital transformation, and US FDA clearance of a new DICOM viewer for diagnostic use as a Class II medical device.

The new solution addresses data sharing and transfer, and includes a governance module to help users comply with regulatory policies and manage sensitive information, a service to help users customize and transform their clinical workflows, and a partner integration service.

The new solution, developed by Box (Redwood City, CA, USA; www. box.com), is intended specifically for hospitals and uses the Box enterprise content management platform. The system helps streamline referral management, and allows medical professionals to view and share Digital Imaging and Communications in Medicine (DICOM) files (including X-Ray,

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Computed Tomography (CT) and ultrasound exams), and facilitates access to data in proprietary hospital enterprise information systems.

The DICOM viewer uses the Box platform and allows clinicians to view DICOM images from the web or mobile devices, provides secure collaboration and image sharing across sites, and remote diagnostics.

The Box will also be further integrated with the TigerText US Health Insurance Portability and Accountability Act (HIPAA) compliant messaging solution. The TigerText mobile interface will enable clinicians to collaborate on clinical images for consultations.

Itamar Kandel, president of TigerConnect, TigerText, said, “As the

Satellite Networking Provides Remote Telemedicine Capabilities new satellite-based e-health platform will allow Friendship (Dhaka, Bangladesh; www.friendship-bd.org) floating hospitals to establish communications from remote areas and offer telemedicine counselling to marginalized communities.

Satmed, developed by SES (Luxembourg; www.ses.com), is a newly deployed satellite-based e-health platform that will enable Friendship to establish communications with national and international doctors for the exchange of medical knowledge with local doctors. The information technology (IT) enabled cloud infrastructure is accessible around the globe, facilitating data exchanges between professionals and medical frameworks such as electronic medical records (EMRs) and teleradiology systems.

With the technical assistance of Square Informatix (Dhaka, Bangladesh; www.e-home2u.com), Friendship launched the first state-of-the-art maritime very small aperture terminals (VSATs) on three of their floating hospital ships - the Lifebuoy Friendship Hospital, the Emirates Friendship Hospital, and the Rongdhonu Friendship (formerly the Rainbow Warrior II) Hospital. The Satmed platform is funded by the Luxembourg Government and implemented in co-

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leading messaging solution for hospitals across the nation, we are excited to deepen our integration with Box around their new Box DICOM Viewer. Leveraging our APIs, Box will give doctors the ability to access imaging studies on their mobile phones via the Box DICOM Viewer. This en-

hances our ability to provide important clinical information in a secure format at the point-of-care.”

Image: The DICOM viewer for X-Rays, CT, or MRI scans, ultrasounds, and mammograms (Photo courtesy of Box).

operation with SES Techcom Services and SES e-Medical Communication (eMC).

“The Satmed project is a great illustration of a true partnership between governments, the private sector and NGOs. Mutual trust and collaboration can enable innovative steps forward, and lead to deep benefits that impact directly on the beneficiaries,” said Runa Khan, founder and executive director of Friendship.

“Satmed gives us a tool by which we are able to bring in specialized services of e-learning, special doctors, specialized back office resources, decisions of problems and ethical decisions, all this can be centralized and the same message can be given organization wide.”

“After implementing Satmed platform tools and services, the ship hospitals, via satellite connectivity, will be able to support and facilitate work in the areas of e-care, e-learning, esurveillance, e-health management, and digital imaging,” said Gerhard Bethscheider, managing director of SES Techcom Services. “The SATMED platform makes e-health available, accessible and easy to use, with a goal to increase efficiency in healthcare and in-field health quality for Friendship especially in remote isolated areas.”

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Envision Healthcare to Acquire Emergency Physicians Medical Group nvision Healthcare Holdings (EVHC; Greenwood Village, CO, USA; www.evhc.net) has entered into a definitive agreement to buy Emergency Physicians Medical Group (EPMG; Ann Arbor, MI, USA; www.epmg.com) for USD 120 million.

EPMG addresses nearly one million patients annually in 37 facilities, including emergency rooms (ERs), hospital medicine departments, and urgent care centers across the Midwest. EPMG also conducts community para-

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medicine programs and offers telemedicine services in urgent care and postacute care operations via more than 500 clinical providers in Michigan, Illinois, Indiana, Ohio, Iowa, and Delaware. The acquisition is part of an attempt to invite physician groups interested in building team-based and integrated solutions for health plan, hospital system, and community partners.

EVHC provides care across a broad patient continuum via three daughter companies: American Medical Response (AMR), which provides

community-based medical transportation, including emergency, non-emergency, managed transportation, air ambulance, and disaster response; EmCare, which provides facilitybased physician services for emergency, anesthesiology, hospitalist/inpatient care, radiology, tele-radiology and surgery; and Evolution Health, which offers comprehensive patient care delivery coordination across a number of healthcare settings.

“We have advanced our marketcentric strategy for several years and this is yet another example of how we are building strategic centers of healthcare excellence in key geographic locations,” said William Sanger, president, CEO, and chairman of the board of Envision. “EPMG has very strong relationships with its healthcare part-

ners, which will open doors for us to add additional hospital-based services, as well as expand community health offerings through opportunities with AMR and Evolution Health.”

“EPMG is celebrating 40 years of delivering innovative and compassionate care and we found ourselves considering opportunities to further evolve, so we are well positioned to best serve our patients for the next 40 years,” said Christopher Newton, MD, president, CEO, and managing partner of EPMG. “Joining the Envision team not only allows us unparalleled infrastructure support and the ability to offer additional integrated services to our facility partners, it enables us to broaden our reach in our communities by partnering with EmCare, Evolution Health, and AMR.”

81% of USA Consumers Dissatisfied with Healthcare Experience new study reveals that a large gap exists between the healthcare experience consumers perceive and what providers believe they are offering.

The study commissioned by Prophet (San Francisco, VA, USA; www.prophet.com) and GE Healthcare Camden Group (Chicago, IL, USA; www. thecamdengroup.com) found that despite the fact that consumer frustrations are high, hospital CEOs surveyed did not place patient satisfaction among their top five priorities. In fact, they said they struggle to prioritize patient satisfaction against competing priorities, such as adapting to changing government regulations, growing consolidation pressures, and the transformation from volume to value-based care.

Healthcare providers overestimated the overall quality of the experience they provide by more than 20%, and as healthcare systems consolidate and the transformation of payment and care models accelerates, patient experience appears to be getting worse, not better. For example, between 2013 and 2014, the healthcare industry saw a 14% increase in consolidation, and a 3% decline in patient satis-

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faction. The report authors claim, however, that investments toward enhancing the patient experience (if done correctly) will help improve an organization’s operational efficiency and bottom line.

To help overcome this challenge, Prophet and GE Healthcare Camden Group have integrated their expertise in patient experience strategy and operational and change management to create a 360-degree patient experience offering. This could help healthcare providers develop a holistic patient experience strategy that supports organizational priorities, and successfully implement a data-driven and cost-effective plan that will drive efficiencies, fix experience gaps, improve the patient experience, and impact the health systems’ key financial targets.

“Providers are struggling to adapt to the rising culture of ‘consumerism,’ which has heightened people’s expectations. The power has shifted to the consumer in nearly every industry, and now its healthcare’s turn,” said Paul Schrimpf, co-lead of Prophet’s healthcare practice. “As consolidation streamlines the number of healthcare players in a market, the ones left standing and thriving will be

the systems that provide a differentiated and exceptional experience for its patrons.”

“The priorities of health system leadership and their patients are not in conflict. For both parties, wait time is wasted time,” said Helen Stewart, managing principal at GE Healthcare. “The common misperception is that focusing on the patient experience means spending less time on other cost and revenue initiatives, which doesn’t have to be the case. Investments to improve the patient experience can drive both growth and cost reduction.”

“The results of our study prove that to be successful, healthcare providers need to modernize their approach to patient experience,” said Laura Jacobs, president of the GE Healthcare Camden Group. “Creating better and more holistic experiences doesn’t just mean happier patients. It translates to increased capacity, lower operating costs, improved financial performance, and higher employee satisfaction and retention. For healthcare providers, the key to profitability and longevity lies in their ability to deliver a superior consumer experience.”

Genesis HealthCare to Sell Home and Hospice Operations enesis HealthCare (Kennett Square, PA, USA; www.genesishcc.com) has signed an agreement to sell the majority of its home health and hospice operations to Compassus (Brentwood, TN, USA; http://compassus.com) for USD 84 million. The Genesis home health and hospice operations included in the deal are located in the states of California, Idaho, Montana, and New Mexico; remaining hospice operations in Arizona and Nevada will be closed. The agreement is part of an ongoing strategic move launched by Genesis to monetize non-strategic assets, including the home health and hospice businesses, in order to repay debts. The strategy is expected to yield a cash flow income of USD 100–150 million, after tax.

The home health and hospice operations became part of Genesis HealthCare following its February

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2015 merger with Skilled Healthcare, which created one of the largest post-acute care providers in the United States. The buyer, Compassus, is comprised of a nationwide network of community-based postacute care services primarily focused on hospice, palliative, and home health care. The company opened its first hospice in 1979, and following the deal will operate more than 165 programs in 30 states.

“Home health and hospice services are nonstrategic businesses for Genesis to operate at this time, and we believe we can better allocate the capital by de-levering our balance sheet,” said George Hager, Jr., CEO of Genesis HealthCare.

“We are excited to welcome Genesis’ home health and hospice businesses to the Compassus family, as we share very similar missions and values,” said James Deal, CEO of Compassus. “As

Compassus continues to grow, this further strengthens our ability and desire to provide greater access to a continuum of high-quality post-acute care, including hospice, palliative, and home health care services to even more patients, families and the health care professionals who serve them.”

According to the Wall Street Journal (WSJ), the supersizing of the healthcare industry in the United States is a result of the Affordable Care Act, and reflects the efforts of providers to gain the scale necessary to succeed amid the changes unleashed or accelerated by the health law. Those include growing pressures to constrain costs and new forms of payment that require providers to meet efficiency and care-quality goals. The process has so far not been slowed down by the growing regulatory concern about health-care consolidation.

HospiMedica International August-September/2016

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Industry News

Infusion Pump Market Estimated at USD 7 Billion he global market for infusion medical pumps grew at an average rate of 2.6% from $6.1 billion in 2010 to almost $7 billion in 2015. These are the latest findings of Kalorama Information, (New York, NY, USA; www.kalorama information.com), an independent medical market research firm.

Infusion pumps are used to provide necessary fluids, basic fluids for hydration as well as pain medications, antibiotics, or chemotherapy, to a patient’s circulatory system. They are mostly used in emergency departments, operating rooms, and neonate departments of hospitals, long-term care settings, physician’s offices, and home settings when continuous monitoring and treatment is expensive, impractical, or unreliable.

Medical infusion pumps are divid-

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ed in six categories, namely large volume infusion pumps, ambulatory infusion pumps, syringe infusion pumps, insulin infusion pumps, implantable infusion pumps, and enteral feeding pumps. Large volume infusion pumps are used for delivery of nutrients and hydration products to patients, while ambulatory infusion pumps are commonly used in hospital, surgical, home and emergency medical facilities. Syringe pumps are used for the delivery of precise amounts of fluid and drugs to patients, while insulin infusion pumps are employed for diabetes management in patients. Implantable infusion pumps are used for specific drugs, dosages, and routes of administration, while enteral feeding pumps are uses to provide liquid nutrition into the digestive system.

Siemens and ADRZ to Build and Manage Operating Theaters iemens Healthineers (Erlangen, Germany; www. healthcare.siemens.com) and Admiraal de Ruyter Hospital (ADRZ, Goes, The Netherlands; www.adrz.nl) have entered into an agreement to build and supply equipment for six operating theaters, including a hybrid OR. This follows a similar agreement between them reached earlier this year, with Siemens agreeing to build, construct and supply medical systems for ADRZ's new Nuclear Medicine Center in Goes. ADRZ is the biggest hospital in the Zeeland Province in the southern part of the Netherlands.

Siemens will build the new build-

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ing complex, equip the new operating theaters with medical systems and service, and update the equipment for ten years. The new complex will house six operating theaters, which will all be set up in exactly the same way for uniform running lines and logical order to help the medical staff achieve the highest possible medical outcome and provide for the best possible patient safety.

The new building complex is expected to be completed in February 2017 at a total project cost of more than EUR 10 million. After the completion of the construction work, Siemens will lease the new building and medical systems to ADRZ.

Acquisition of HeartWare International to Expand Medtronic Cardiac Portfolio edtronic plc (Dublin, Ireland; www.medtronic.com) will acquire HeartWare International, Inc. (Framingham, Massachusetts, USA; www.heartware. com) in a transaction valued at approximately $1.1 billion. The acquisition of HeartWare, which provides less-invasive, miniaturized circulatory support technologies for the treatment of advanced heart failure, will expand Medtronic's portfolio of diagnostic tools, therapies and services for patients suffering from heart failure.

Heart failure, or congestive heart failure, is a condition or a set of symptoms in which the heart cannot pump

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HospiMedica International August-September/2016

the amount of blood required to meet the body's needs. Heart failure often develops gradually following an injury to the heart with injuries including a heart attack, excessive strain on the heart as a result of high blood pressure remaining untreated for years, a diseased heart valve, etc. Heart failure is the number one cause of hospitalization and death in the United States and continues to witness an increase in prevalence, with over five million people being afflicted in the United States alone. Heart failure comes at a high cost and its expense to the United States’ healthcare system is one of the largest at about $39 billion annually.

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SEPTEMBER 2016 ERS 2016 – Annual Congress of European Respiratory Society. Sep 3-7; London, UK; Web: www.erscongress.org 35th Annual ESRA Congress 2016The European Society of Rergional Anaethesia and Pain Therapy. Sep 710; Maastricht, The Netherlands; Web: http://esraeurope.org/meetings EACMFS 2016- European Association for Cranio Maxillofacial Surgery Congress. Sep 13-16; London, UK; Web: www.2016.eacmfscongress.org 26th World Congress on Ultrasound in Obstetrics and Gynecology. Sep 25-28; Rome, Italy; Web: www.isuog.org

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