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THURSDAY, FEBRUARY 5 , 2015 VOLUME 19, NO. 25

MEDICAL DEVICE DAILYTM

THE DAILY MEDICAL TECHNOLOGY NEWS SOURCE

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See Budget, page 8

See Medtronic, page 6

See Philadelphia, page 7 See OECD, page 5

INSIDEGATES FOUNDATION JOINS IN SERA’S SERIES B FUNDING PAGE 2INSULET EXTENDS INTEGRATION OF ABBOTT’S FREESTYLE BG SYSTEM PAGE 3

REGIONAL INNOVATION REVIEW

INSIDE THE BELTWAY

Executive Editor Holland Johnson on one of med-tech’s key sectors

Read this week’s Thursday Special

ORTHOPEDICS EXTRA

OECD reports advances in EU healthdespite crisis, spending cuts By John Brosky, Europe Editor

PARIS — Confirming what medical technology companies have long known, a pan-European report from the Organization for Economic Cooperation and Development (OECD; Paris) confirmed that spending on healthcare fell dramatically across half of the European Union (EU) countries and slowed significantly elsewhere.

On average expenditures on health adjusted for inflation decreased by 0.6% each year between 2009 and 2012, compared with annual growth of 4.7% between 2000 and 2009, according to the European Core Health Indicators developed jointly by the OECD and the European Commission (EC; Brussels) for this third edition of Health at a Glance in Europe.

Philadelphia area home to a host ofdiverse medical device companiesBy Jeffrey Berg, Contributing Writer

A proliferation of medical device companies are located in Philadelphia and its surrounding counties in southeastern Pennsylvania. Of note, are the cluster of companies marketing or developing vascular, spinal and neurologic devices.

Vascular Medical Devices Intact Vascular (Wayne) develops minimally invasive

peripheral vascular products. Its Tack Endovascular System is designed to optimize peripheral balloon angioplasty in the treatment of peripheral artery disease. Angioplasty creates

FDA approves Medtronic’s Melody TPVto prolong time between surgeriesBy Amanda Pedersen, Senior Staff Writer

A device that had previously been available under a humanitarian device exemption (HDE) now has FDA pre-market approval to prolong the time between open-heart surgeries for patients with a dysfunctional right ventricular outflow tract (RVOT) conduit by congenital heart disease (CHD).

Trysla says site-neutral payment greatest danger in new FY16 budgetBy Mark McCarty, Washington Editor

The Obama administration’s fiscal 2016 budget proposal is not widely seen as having much chance in the GOP-led House of Representatives, and one reason may be that the proposal includes several controversial healthcare-related items. One is that the administration would like to make more extensive use of pre-authorization for some imaging procedures, but the White House also expressed an interest in pushing through site-neutral payments for many Medicare services. The opposition to site neutrality is widespread, but other Medicare matters with significant budgetary effects may prod legislators to go along

In this issue: Medical Device Daily is pleased to present Pat-ent Highlights,an excerpt of the most important med-tech patents from this week’s Cortellis Patents Gazette. Please go to the insert at the end of the issue to learn more about this great product and to see the hand-picked med-tech patent highlights from the editor.

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FINANCINGS

Gates Foundation joins inSera’s series B funding Staff Report

Sera Prognostics (Salt Lake City) said the Bill & Melinda Gates Foundation (Seattle) has agreed to join the company’s Series B financing, which will bring the total transaction to $25 million. The additional funding will help Sera expand the reach of its proteomic technology, to develop new tests designed to predict the risk of preterm birth for women in developing countries around the world.

“We are pleased to have the Bill & Melinda Gates Foundation agree to join us as an investor. This collaboration has the potential to help address the enormous global challenge in preterm birth by identifying risks early in pregnancy with the goal of improving the health of mothers and infants worldwide,” said Gregory Critchfield, chairman/CEO of Sera Prognostics. “We believe that our technologies will help clinicians around the globe to make a real difference for their patients.”

According to the March of Dimes’ Global Action Report on Preterm Birth from 2012, each year more than 15 million infants are born prematurely worldwide and one million die from preterm birth complications. In addition, many experience lifetime visual, hearing and learning disabilities. These rates are rising and today preterm birth is the leading cause of newborn death and the

second leading cause of death in children under age five.Sera has completed enrollment of 5,500 patients from

eleven U.S. clinical sites in its landmark Proteomic Assessment of Preterm Risk (PAPR) clinical study and expects results to be available during 2Q15. PAPR is the largest singleton pregnancy proteomic study enrolled in the U.S. to date for the purpose of developing a broadly generalizable preterm birth predictor. Sera and the Bill & Melinda Gates Foundation will use the experience from the PAPR study and the development of Sera’s PreTRM test to advance the development of a new tool that can be effectively and economically deployed in underserved developing countries to identify women’s risk of preterm birth.

Sera’s PreTRM test will use a routine blood sample obtained during the second trimester of pregnancy to provide an early and individualized assessment of a woman’s risk of preterm birth. Upon launch in the U.S., commercial testing will be performed at Sera’s state-of-the-art CLIA laboratory with results returned to referring physicians. Physicians may then use this information to help guide clinical decisions with respect to personalized interventions intended to improve newborn health and potentially reduce the costs of healthcare delivery, including prolonged stays in neonatal intensive care units.

Sera Prognostics is a private company developing diagnostic tests designed for the early prediction of preterm birth risk and other pregnancy complications. Sera’s tests are designed to help better inform the care of a mother and her unborn child during pregnancy, and potentially lead to improved health. //

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AGREEMENTS/CONTRACTS

HIT BITS

Insulet extends integration ofAbbott’s FreeStyle BG systemStaff Report

Insulet (Billerica, Massachusetts), a maker of tubeless insulin pump technology with its OmniPod insulin management system, has extended its ongoing exclusive agreement with Abbott Laboratories (Abbott Park, Illinois) to continue integration of the Abbott FreeStyle blood glucose (BG) monitoring technology with Insulet’s OmniPod. The FreeStyle blood glucose meter is built into the OmniPod hand-held Personal Diabetes Manager (PDM), eliminating the need to carry and manage a separate meter or transfer BG results from device to device.

“We have enjoyed a successful collaboration with Abbott for more than a decade and we are very pleased to continue our longstanding relationship,” said Patrick Sullivan, president/CEO of Insulet. “Tens of thousands of OmniPod users around the world are using the FreeStyle strip platform today and we’re pleased to be working with Abbott to incorporate the FreeStyle Lite® technology into our next-generation PDM currently in development.”

FreeStyle test strips with ZipWik tabs are cleared for use with the OmniPod Insulin Management System.

Through its OmniPod Insulin Management system, Insulet says it seeks to expand the use of insulin pump therapy among people with insulin-dependent diabetes. The OmniPod is a tubeless insulin pump that features just two parts and a fully-automated cannula insertion.

In other agreements/contracts:• El Centro Regional Medical Center (ECRMC; El Centro,

California), a city-owned acute-care medical center, has selected 3t Systems (Greenwood Village, Colrado) as their new healthcare technology partner, engaging in a multi-million/multi-year contract agreement.

ECRMC, located approximately 115 miles east of San Diego, is a 161-bed medical center with several connected outpatient centers and is the largest hospital in Imperial Valley.

As a healthcare technology partner with expertise in security, compliance and cloud services, 3t Systems will manage ECRMC’s core IT infrastructure, application delivery, and network operations. In addition, 3t Systems will support ECRMC with secure data center hosting, data backup, disaster recovery, as well as systems monitoring and reporting.

3t Systems is a healthcare IT services company providing clinicians and administrators the ability to deliver extraordinary patient care.

• Cerus (Concord, Califorina) and the Blood Bank of Delmarva (BBD; Newark, Delaware) announced today that they have signed a three-year purchase agreement

for the Intercept Blood System for platelets and plasma. BBD provides blood transfusion products and services to hospitals and patients in Delaware, Cecil County, Maryland, as well as Maryland’s and Virginia’s Eastern Shores. BBD supplies approximately 13,000 platelet and 21,000 plasma units per year.

“The implementation of the INTERCEPT system aligns with our mission of providing safe, effective blood products that best serve our hospital and patient community,” said Roy Roper, president/CEO of BBD. “We are excited to be one of the first centers to adopt pathogen reduction as a proactive measure to mitigate the risk of transfusion-transmitted infections in our blood supply.”

BBD is a not-for-profit 501(c)(3) community service organization that provides blood and blood components for hospitals in the Delmarva region.

Cerus is a biomedical products company focused in the field of blood safety. //

McKesson Medical-Surgical adopts Eclipse’ DocOrigin 3.0Staff Report

Eclipse (Cape Coral, Florida), a provider of enterprise document generation solutions, reported that McKesson Medical-Surgical (Romeoville, Illinois) has adopted DocOrigin 3.0 to support critical enterprise document generation systems.

“The McKesson business unit needed a next-generation solution to replace our current print program,” said Don Fauth, VP of application development.

McKesson needed a more modern and efficient solution, Fauth said. “We process large volumes of print, especially at peak times. With our current software we sometimes experience a slow-down that can impact our shipments to customers. Re-platforming our critical print processes was an essential change,” he said.

McKesson Medical-Surgical chose DocOrigin as the solution. According to Jeff Gary, business development manager at Eclipse, DocOrigin was uniquely suited to provide the level of capability and performance that McKesson Medical-Surgical needed.

“Many of their applications are complicated. For example, their packing slips have 108 sub-forms, so key criteria for success was to increase speed, ease migration and retain the current functionality across all the applications and systems,” said Gary.

According to Steve Luke, CEO of Eclipse, McKesson Medical-Surgical evaluated a number of possible solutions before determining that DocOrigin’s performance, features and ease of use made DocOrigin the best choice.

The company also was interested in the dynamic promotion capabilities, messaging and 3-D charting features included with DocOrigin, Eclipse noted. //



PEOPLE IN PLACES

WORLD IN REVIEW

Consort signs supply agreement for integrated dose counter systemStaff Report

Consort Medical (Hemel Hempstead, UK), a single source drug and delivery company, reported the conclusion of a new commercial supply agreement for its proprietary integrated dose counter (IDC) system. The multi-year supply agreement covers supply of both the IDC actuator and the pressurized metered dose inhaler (pMDI) valve. This IDC program represents the first commercial oral variant of the device, which is already approved and marketed for a nasally delivered product.

Dose-counting devices fullfill an important patient and compliance need to let patients know if their device contains sufficient drug and to indicate when they need to seek a further prescription. It provides patients with a reliable, easy to read indication of how many doses are left inside the canister in line with FDA guidance.

Jonathan Glenn, Consort Medical’s CEO said, “Consort Medical has a long heritage of excellence, reliability and innovation and we strive to be the partner of choice for pharmaceutical companies, enabling them to implement drug delivery technologies that can streamline and accelerate the route to market for their drugs. With the conclusion of this agreement for our IDC device we have reinforced the ongoing strength of our respiratory device franchise, in particular in the pMDI segment, and created a significant business opportunity.”

The device will be manufactured in the Consort Medical company Bespak’s existing IDC facility at King’s Lynn.

Micell launches MiStent SES in EuropeMicell Technologies (Durham, North Carolina), a company

that is enhancing the performance of cardiovascular medical devices with innovative drug-delivery systems, reported the availability of the MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES) in Europe. Stentys, Micell’s distribution partner in Paris, plans a controlled launch in Western Europe followed by a full commercial launch for the second half of 2015 in selected countries within Europe, Middle East, South-East Asia and Latin America.

MiStent SES has received the CE mark in the European Union, and will be distributed exclusively by STENTYS around the world, with the exception of the United States, Canada, China, South Korea and Japan. Micell is in the process of expanding its manufacturing capabilities through its partner, Surgical Technologies (St. Paul, Minnesota).

MiStent SES is designed to optimize healing in patients with coronary artery disease. The absorbable coating of the MiStent SES is intended to precisely and consistently provide for local drug delivery and limit the duration of polymer exposure, thereby potentially reducing the safety risks associated with

current commercially available drug-eluting stents. The MiStent SES includes a proprietary stent coating that contains crystalline drug (sirolimus) and an absorbable polymer. The coating provides controlled and sustained release of therapeutic levels of drug as the polymer disperses from the stent into the adjacent tissue. These properties are intended to enhance safety as compared to conventional permanent polymer drug-eluting stents.

Gore gets Canadian approval for Viabahn EndoprosthesisW. L. Gore & Associates (Flagstaff, Arizona) has received

approval from Health Canada for two innovations of the Gore Viabahn Endoprosthesis with Propaten Bioactive Surface. The 25 cm long endoprosthesis and a lower profile delivery system that the company says gives Canadian physicians more options in treating patient anatomies.

The 25 cm Gore Viabahn Endoprosthesis with Propaten Bioactive Surface is the longest length stent-graft available, and can be used to treat long-segment peripheral arterial disease. The device is constructed with a durable, reinforced, biocompatible, expanded polytetrafluoroethylene liner attached to an external nitinol stent structure. Gore says the flexibility of the Viabahn Endoprosthesis enables it to traverse tortuous areas and conform closely to the complex anatomy of the artery. The stent-graft features the addition of proprietary heparin-bonded technology. The end-point covalent bonding keeps heparin anchored to the endoprosthesis surface while the bioactive site remains free to interact with the blood. //

• Mazor Robotics (Caesarea, Israel) said that Sandra Adzic has been named VP of international sales. Previously, Adzic was senior area sales manager, where she contributed to the company’s growth in the Asian markets. Mazor Robotics makes guidance systems and complementary products.

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OECDContinued from page 1

The decline was credited to cuts in health workforce and salaries, reductions in fees paid to health providers, lower pharmaceutical prices, and increased patient co-payments.

Yet Europe is a highly fragmented landscape as marketing and sales reps with med-tech companies know only too well, and painting a big picture for Europe requires broad brush strokes that do not reflect the uneven performance, and can mask the opportunities, among the 28 members of the EU.

For example, the OECD pointed out that health spending grew during the study period in Austria, Germany and Poland while it spiral downward in Greece, ltaly, Portugal and Spain, Hungary and the Czech Republic.

Due to the aging of the European population, the report noted that the EC’s office for economy and financial affairs projects the demand for health spending, and especially for long-term care, will exert a sustained pressure on EU countries in the years ahead, on average claiming another 1% to 2% of gross domestic product.

Meanwhile, the OECD report noted a steady progress since 2000 in the standard of care across the EU that has seen dramatic decreases in mortality of 40% for heart attacks and 20% for stroke victims. Cancer survival has improved modestly and the report credited an improved quality of primary care for reductions in avoidable hospital admissions for chronic diseases such as asthma and diabetes.

Life expectancy at age 65 also increased substantially, averaging 20.4 years for women and 16.8 years for men in the EU in 2012. Life expectancy at age 65 varies by about five years between those countries with the highest life expectancies and those with the lowest, according to the report.

On average across EU countries, the number of doctors per capita increased from 2.9 per 1 000 population in 2000 to 3.4 in 2012, length of stay in hospitals decreased, and the OECD noted that “EU countries have maintained universal coverage for a core set of health services, with the exception of Bulgaria, Greece and Cyprus where a significant proportion of the population is uninsured,” though in these countries measures have been taken to provide coverage for the uninsured.

The wide variances across Europe are well-illustrated by the OECD’s country-by-country breakout for the acquisition and use of medical technologies, and the report cautions that even within countries there are dramatic variations from one region to another.

For example, the availability of CT scanners and MRI units has increased rapidly in European countries overall but holds surprises for where they are to be found. The highest number of MRI units and CT scanners per capita among EU member states are in Italy, Greece and Cyprus. Where the EU average

is for 10.5 MRI and 20 CT scanners per one million people, the availability of MRIs is double that in those countries and more than 50% greater for CTs. The same is true for non-EU countries Switzerland and Iceland.

With the exception of Switzerland, these countries also score high in the rankings for the numbers of exams, but the top two leaders for MRI exams are Germany and France, which have half as many scanners at 11.3 and 8.7 per million people, respectively.

The OECD report emphasized the great variation of scanner exams within a single country, citing the case of Belgium that reported a two-fold difference between provinces.

According to the authors, in England, “where the utilization rate of both types of diagnostic exams is generally much lower, the variation across regions was even greater, with almost a four-fold difference between those Primary Care Trusts that had the highest rates and lowest rates of MRI and CT exams.”

Coronary revascularization combining angioplasty and stent implantations have revolutionized cardiac procedures in Europe effectively supplanting coronary bypass with open-chest surgery that was the standard of care 20 years ago. On average across EU countries, percutaneous stenting now accounts for 80% of all revascularization procedures, and exceeds 85% in Estonia, France and Spain.

The report estimated the average cost of percutaneous revascularization across Europe to be €5,600 ($6,413) in 2011, compared to €13,800 ($15,804) for a coronary bypass.

The OECD report noted that “the large variations in the number of revascularization procedures across countries do not seem to be closely related to the incidence of ischemic heart disease (IHD), as measured by IHD mortality. For example, IHD mortality in Germany is below the EU average, but Germany has the highest rate of revascularization procedures.”

The number of hip and knee replacements has increased across Europe with the most rapid rate of growth seen in knee replacement, though hip replacements continue to have the higher volume of procedures. There were 157 hip replacements per 100,000 people on average across the EU in 2012 and 113 knee replacements.

The report cited the case of Denmark where the number of hip replacement per 100,000 people increased by 40% between 2000 and 2012 to 227 interventions, while the knee replacement rate more than tripled to 171 procedures. In France the growth rate for hip replacement increased between 2000 and 2012 by more than 10% to 230 per 100,000 people, while the knee replacement rate rose by 80% to 139 per 100,000 people.

According to a 2014 study by Koechlin et al. for he OECD, “Comparing Hospital and Health Prices and Volumes Internationally,” the price of a hip replacement on average across European countries in 2011 was €6,800 ($7,786), while the price of a knee replacement was €6,300 ($7,214). //



MedtronicContinued from page 1

Medtronic (Dublin, Ireland) said its Melody Transcatheter Pulmonary Valve (TPV) received FDA approval based on clinical evidence from three studies that demonstrated the valve’s effectiveness in delaying open-heart re-operation. The Melody TPV was previously approved in 2010 under a HDE, a regulatory approval for treatments intended for fewer than 4,000 U.S. patients a year. HDEs are granted for devices that have demonstrated reasonable safety and probable benefit, but do not have evidence of clinical effectiveness. PMA approval has been issued based on the robust evidence now available that supports both safety and effectiveness of the Melody TPV, the company noted.

A Medtronic spokesperson told Medical Device Daily via e-mail, in response to questions about the approval, that pulmonary valve conduit failure can be treated by surgical conduit replacement, balloon angioplasty, bare metal stenting or TPV therapy. “The Melody TPV is a breakthrough product that repairs heart defects,” the spokesperson wrote. “If a patient’s right ventricular outflow tract (RVOT) conduit fails later in life but is still of adequate size to address the patient’s needs (i.e., the patient has not outgrown the conduit), then a Melody TPV can be implanted. The Melody TPV prolongs the time between open-heart surgeries for these patients, many of whom are children who will undergo several surgeries during their lifetimes. Previously, the only option for these patients was open-heart surgery, which is a much more invasive procedure than transcatheter valve implantation.”

While the approval doesn’t change the indication for use, it may simplify the insurance approval process for indicated patients, but does not expand the patient population, the spokesperson added.

According to the Medtronic, more than 7,300 patients worldwide have received the therapy to date, more than half of whom are children with CHD.

“The Melody valve has been a reliable option for patients suffering from CHD, and these data reinforce its strong performance since it was first introduced,” said William Hellenbrand, chief of pediatric cardiology at the Yale School of Medicine (New Haven, Connecticut). “This approval underscores the valve’s importance in treating this small patient population, who over their lifetime will face several open heart surgeries.”

The PMA approval is based on accumulated data from three studies that followed a total of 310 patients implanted with Melody TPV – the Melody U.S. investigational device exemption study, the Melody U.S. post-approval study and the Melody European and Canadian post-market surveillance

study. Data showed strong valve performance in all three studies in patients implanted with the Melody valve as about 98% of patients were free from conduit re-operation (open-heart surgery) at one year post-implant. Additionally, 91% of patients in the IDE cohort were free from conduit re-operation at five years post-implant.

The company spokesperson told MDD that in addition to the strong evidence demonstrating the valve’s effectiveness in delaying open-heart re-operation, data also showed consistently low gradients across all three studies.

“The transition from HDE to PMA is an important regulatory milestone, which truly emphasizes the significant clinical benefit that the Melody TPV can bring to people with CHD by providing a therapy option that may reduce the number of open heart surgeries they need throughout their lifetime,” said Rhonda Robb, VP and general manager of Heart Valve Therapies at Medtronic.

Medtronic noted that PMA status for the Melody TPV provides several benefits, including demonstration of proven effectiveness data and the ability to help streamline reimbursement. //

BRIEFLY NOTED

Vexim gets positive Masterflow results Vexim (Toulouse, France), a medical device company

specializing in the minimally invasive treatment of vertebral fractures, reported the success of 15 surgeries carried out with the Masterflow Injection System at Oklahoma Spine Hospital (Oklahoma City), one of the preeminent American hospitals specializing in spine surgery.

With this success, Vexim says it marks the effective launch of its broader sales & marketing activities in the U.S., reflecting a quick ramp-up of Vexim Inc., Vexim’s wholly-owned U.S. subsidiary set up in Sept. 2014, responsible for commercializing the company’s products through a comprehensive network of carefully-selected spine-specialist agents.

The first surgeries were carried out last December, just days after the system’s FDA registration.

Vincent Gardès, CEO of Vexim, said, “We had been eagerly awaiting feedback from U.S. doctors regarding our Masterflow Injection System, as we knew the satisfaction of both patients and physicians were crucial for the system’s success. We are delighted, but not surprised, that these surgeries have gone smoothly and that the response from physicians indicates a strong desire to use this system to treat their patients. The adoption of this product by surgeons and interventional radiologists is pivotal to our development strategy in the U.S., which is the world’s largest spine trauma market. We are, therefore, highly confident in the success of our ramp-up on this market in 2015 and will further improve our future US commercial strategy in accordance with market feedback. The Masterflow system is also expected to become available in Europe during the first half of this year.”

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PhiladelphiaContinued from page 1

Table: Greater Philadelphia region is a target for acquisitions by major corporations

Philadelphia company Acquiring company Date/Amount

Kensey Nash (Exton) DSM (Heerlen, The Netherlands) June 2012 ($360 million)

Embrella Cardiovascular (Wayne) Edwards Lifesciences (Irvine, California) March 2011 ($43 million)

Orthovita (Malvern) Stryker (Kalamazoo, Michigan) May 2011 ($316 million)

Avid Radiopharmaceuticals (Philadelphia)

Eli Lilly (Indianapolis) November 2010 ($800 million)

Lumenis (Philadelphia) Sonosite (now FujiFilm; Tokyo) December 2011 (Undisclosed)

Arrow International (Reading) Teleflex (Wayne) July 2007 ($2 billion)

Animas (West Chester) Johnson & Johnson (New Brunswick, New Jersey)

December 2005 ($518 million)

tears (dissections) in the vessel wall which are currently treated by stenting. Bruce Shook, president/CEO explained that “the Tack Endovascular System is a much more biologically friendly way of repairing the dissections that occur following angioplasty. With the coming of drug-coated angioplasty balloons, this is really an ideal companion treatment because it leaves a smaller amount of metal in the vessel and produces a minimal amount of mechanical stress on the vessels.”

Cagent Vascular (Wayne) is developing a vessel preparation angioplasty balloon designed to reduce injury and to enhance newer platform technologies such as drug-coated balloons, bioresorbable scaffolds and new metal stent designs. The balloon is intended to serrate, weaken and modify plaque in a controlled way vs. the uncontrolled, random tearing, typically seen with balloon angioplasty which often leads to stent implantation and adds procedural costs.

Essential Medical (Malvern) received the CE mark for X-Seal, a small bore (6-8F) vascular closure for femoral arterial punctures made during cardiac catheterization procedures such as angiogram, angioplasty and stenting. It is undergoing a post-market follow-up study in the EU. It features an improved seal and tensioning gage, and radiopaque marker. MANTA is a large bore (14-18F) closure device that was successfully deployed in first-in-man studies and an IDE application is planned for early 2015. Greg Walkers, CEO, told Medical Device Daily that “large bore closure is being driven by the increasing percutaneous use of larger devices for TAVR and AAA.”

BioConnect Systems (Fort Washington) is conducting a 150-patient pivotal clinical study at 12 sites in the U.S. for its Optiflow family of sutureless anastomotic connectors that provide a fast and repeatable method for connecting vessels. The company seeks to replace the microvascular suturing of the AV fistula. Adam Dakin, President and CEO, said “the AV fistula procedure fails within 5 months and the 400,000 hemodialysis

patients in the U.S. need longer term vascular access.” The company’s implant will be available in 3 mm and 4 mm sizes, as needed to match the anatomy and size of the target vessels.

Velano Vascular (Philadelphia), is developing a proprietary, simple, disposable technology that will eliminate the need for needle sticks with blood draws in the hospital. The company’s technology enables a safe and reliable aspiration of blood from IVs already in place. Velano Vascular received funding from the City of Philadelphia’s UpStart PHL fund, as well as from Philadelphia’s own First Round Capital.

Spinal Implants Globus Medical (Audubon) markets a broad line of

spinal implants. Dave Demski, president/COO, highlighted the company’s ability to innovate and generate about 15 new products annually, thereby gaining share in a competitive market. It currently markets more than 100 musculoskeletal implants and has more than 30 additional products under development. About 90% of the company’s sales are in the U.S.

Centinel Spine (West Chester) focuses on integrated interbody cages that are stand alone, low profile devices. They use a screw and cage concept. The compression screws hold the vertebral body compressed against the cage to alleviate the need for additional fixation. It is the leader and first company to introduce stand alone, low profile devices. Innovation in this category of devices is continuing with the introduction of textured Ti-active coating on its PEEK cages.

Gentis (Wayne) is a developing DiscCell to treat the early-stage degeneration of the spine. It is an injectable in-situ setting, radio-opaque, non-hydrogel polymer that augments or replaces the diseased nucleus pulposus of the spinal disc. Clinical trials have been conducted in Europe and a 10-patient study in Athens will soon be completed, followed by filing for the CE mark.

Diagnostic and Therapeutic Devices for Brain DisordersInfraScan (Philadelphia) markets the Infrascanner, a

handheld brain hematoma detector for intracranial bleeding from a head injury or stroke. It provides a graphic report in 2-3

See Philadelphia, page 9

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BudgetContinued from page 1

with the site neutrality idea, according to at least one observer.The budget proposal crosses swords with a bipartisan

group on Capitol Hill by means of a proposal to trigger the Independent Payment Advisory Commission more readily, resetting the healthcare spending inflation trigger point from 1% over gross domestic product to 0.5%. Several bills with support from both parties have made the rounds on Capitol Hill to excise the IPAB-related provisions in the Affordable Care Act from the statute, but nothing has come of any such legislation as yet.

An alliance of providers, manufacturers and patient groups has already announced its opposition to the pre-authorization notion, namely the Access to Medical Imaging Coalition (AMIC; Washington), which released a Feb. 4 statement blasting both pre-authorization and site-neutral payments for radiology. Tim Trysla, executive director of AMIC, told Medical Device Daily that despite the long history behind and considerable opposition to pre-authorization, “our biggest legislative threat in the budget is site-neutral payment.”

Trysla acknowledged that the pre-authorization notion has bounced around for a while, stating, “I think it is something they continue to highlight” because it serves as “a fall-back when you’re seeing an increase in services.” He remarked that Congress and two administrations have imposed a decade “of cuts on the physician side, so the growth is not there” to justify “these harsh stops.”

The Protect Access to Medicare Act of 2014 (PAMA) requires some limited application of pre-authorization, mandating that the Centers for Medicare & Medicaid Services (CMS) impose pre-authorization on the 5% or less of physicians whose prescribing practices are outliers, but this requirement does not go into force until 2020. The FY 2016 budget proposal adds to that by capturing nearly all prescribing physicians doing business with Medicare, and Trysla said the threat of even more extensive use of radiology benefits manager (RBM) entities is very real despite that PAMA also allows for the use of appropriate use criteria (AUC) developed by professional societies.

RBMs could come into more widespread use “whether through a regulatory process or a rule in the Medicare physician fee schedule,” Trysla said, but he noted that an expanded effort could drag more providers into the fray. “If they’re going to do it, they’ll have to do it with hospitals, and there are bigger issues with hospitals right now,” including site-neutral payment, he said.

PAMA’s inclusion of an AUC mechanism for controlling utilization seems to have done little to allay concerns, and Trysla indicated that CMS has some decisions to make in terms of enforcing the PAMA requirements. “I think this next regulatory

step is going to be a huge step,” he forecasted, but he remarked, “the real question is ‘does anyone understand the impact of this?’” He made the case that performance and behavioral indicators such as AUC standards would do the job, but added that the administration is “looking at this as a reimbursement argument as opposed to trying to improve quality and reduce cost.”

Hospital administrators will be pressed to improve coordination of care as one way to suppress inflation, but those efforts may not suffice to provide some relief from the Part A side. “The challenge we have with the budget is that many want the sustainable growth rate (SGR) to be fixed permanently or get as long a patch as possible,” but Trysla said the new list of potential cuts, several of which affect imaging, “certainly have the potential of being picked up” as an offset for the doc fix.

“This is the new list, and imaging continues to be in the crosshairs,” Trysla observed.

“I don’t know anyone who’s justifying the dramatic cuts to the [Medicare] physician fee schedules” over the past half decade or so, “and then turning around and saying ‘we now think that’s the [level of reimbursement] we can pay hospitals’,” Trysla said. He made the argument that physician payment “is already artificially low,” but pointed out that hospital cost estimates are derived from reports that reflect different resource usage, which is of course affected by infrastructure requirements such as maintenance of emergency rooms.

The site-of-service overhaul as spelled out by the administration would be phased in over four years starting in 2017, and Trysla said the House Budget Committee “is going to have their own take” on that and other features of the budget proposal. He stated further, “where the rubber hits the road is the Ways and Means Committee in the House,” which has to come up with either a permanent fix or yet another patch for the sustainable growth rate mechanism by April 1, when the current patch expires. Ways and Means and the House Energy and Commerce Committee both have jurisdiction over that issue, but Trysla said the SGR problem is “the real dynamic. The budget is to some extent a document that outlines principles without a lot of detail,” Trysla said, predicting, “by April 1, some of these cuts will be considered” to pay for SGR, although he noted that Congress could opt yet again for another patch.

As for the IPAB question, Trysla said, “there’s nothing to convince me that this proposal isn’t dead on arrival,” characterizing the function of IPAB as “a budget gimmick. We know this is widely unpopular,” but he added that it is significant “on paper [because] you get some savings by lowering the target” for IPAB action.

Despite the widespread and bipartisan distaste for IPAB, repeal will be no mean feat. “In order to get rid of spurious laws and regulations, you have to pass a law and pay for it,” Trysla mused, and consequently, “from a budget standpoint, it’s difficult to get it done.” //

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PRODUCT BRIEFS

PhiladelphiaContinued from page 7

minutes and utilizes near infrared technology. The product was evaluated in a 431-patient multi-center clinical trial. Its primary customers are the military for use on the battlefield and in international markets where CAT scanners are not available.

NeuroDx Development (Bensalem) is developing a non-invasive intra-cranial (ICP) pressure monitor for use on patients with brain injuries. There are no non-invasive tests for measuring elevated ICP. The product is in animal tests and limited human testing. Also under development is an implanted ICP device for use on hydrocephalus shunts which is funded by a grant from the NIH.

NeuroDx received FDA clearance in May 2013 for ShunkCheck, an aid for the detection of flow in implanted cerebrospinal fluid shunts. It is in limited distribution. A test pack is sold for $200 that includes a sensor, instant cold pack and skin marker pen. It is currently used on symptomatic patients and the company’s aim is to incorporate the test into annual exams to track shunt flow performance. There are 300,000 patients with hydrocephalus shunts in the U.S.

Neuronetics (Malvern) markets the NeuroStar TMS (transcranial magnetic stimulation) therapy system, a non-invasive, non-systemic treatment for depression that uses a highly focused, pulsed magnetic field to stimulate function in targeted brain regions. It is performed as an outpatient procedure in a physician’s office or hospital setting and can be used to treat the 4 million patients that suffer from major depressive disorder and for which anti-depressant drugs and electrical shock therapy are ineffective. More than 23,000 patients have been treated with NeuroStar. Chris Thatcher, president/CEO of Neuronetics, noted that “the commercial challenge is to get reimbursement for a truly pioneering therapy.”

The Greater Philadelphia region has also been target for acquisitions by major corporations, as listed in the table on page 7. //

• BeneChill (San Diego) reported positive results from the COOLHEAD Clinical Study. The purpose of the study was to determine the effectiveness of intranasal evaporative cooling for the treatment of acute migraine headaches. The study protocol was designed for patients to receive one treatment per migraine incident. Patients could be treated for multiple migraines throughout the study’s duration. A total of 20 treatments were provided (12 patients received one treatment, 3 patients received 2 treatments, and one patient received 3 treatments). BeneChill’s products consist of a portable control unit, a nasal catheter and a bottle of cooling fluid. A maximum intranasal cooling period of 20 minutes was allowed per treatment; however, the average treatment time delivered was 15 minutes of cooling. Primary endpoints for the COOLHEAD Clinical Study were the reduction in pain and in associated symptoms. BeneChill is a medical device company which makes rapid cooling products to improve clinical outcomes.

• Interpace Diagnostics (Parsippany, New Jersey) reported the publication of results of the pivotal PancraGen multicenter clinical validation study in the February 2015 issue of Endoscopy. The study concluded that PancraGen (formerly PathFinderTG-Pancreas) is 90% accurate at predicting benign and malignant disease in patients with pancreatic cysts, providing important insights into patients’ likelihood of pancreatic cancer. These results provide support for using PancraGen to provide more informed management decisions for patients with pancreatic cysts, including whether surgery or surveillance is the most appropriate approach. This outcome was based on data from the National Pancreatic Cyst Registry, a 492-patient multicenter registry study that followed patients who had PancraGen testing as part of their care when cytological analysis of cyst fluid was inconclusive. Interpace Diagnostics’ PancraGen test uses the PathFinderTG platform, which assesses multiple tumor suppressor and oncogene DNA abnormalities. PancraGen integrates this DNA analysis with clinical features of pancreatic cysts to accurately stratify patients for risk of pancreatic adenocarcinoma with better accuracy than standard guideline-recommended tests alone. All patients with pancreatic cysts, except those with clear cytological malignancy, are ideal candidates for testing with PancraGen.

• Paradigm (Ann Arbor, Michigan) reported an expansion to their Paradigm Cancer Diagnostic (PCDx) service with the addition of key protein biomarkers analyzed by immunohistochemistry (IHC). This enhancement will include the addition of up to 21 IHCs linked to either oncologic therapies or targeted clinical trials increasing the number of actionable drug targets to 65 which is the largest number commercially available. Of the 21 IHCs, 15 will be available immediately and include: PD1, PD-L1, MGMT, MET, TOP1, PTEN, AR, CAIX, ER, HER2, IDO, PR, TRKA, TRKB and TUBB3. The addition of other key targets including hENT1, TS, CTLA4, TLE3, LAG3 and TP is scheduled in a few weeks. With this expansion, Paradigm says this PCDx test now provides the ability to interrogate DNA mutations, chromosomal changes, mRNA expression, Copy Number Variations and

Protein Expression. Currently, Paradigm is the only organization with the ability to interrogate mRNA targets by NGS in formalin fixed paraffin sections along with the other genomic markers.

• SpineGuard (Paris) has received FDA clearance to market its PediGuard products for minimally invasive surgery (MIS). Cannulated PediGuard expands the applicability of pedicle screw placement with real-time feedback by allowing spine surgeons to benefit from the Dynamic Surgical Guidance technology value proposition in the small, confined spaces of MIS. This represents a branch of spine surgery where SpineGuard’s PediGuard technology delivers unparalleled benefits for the patient, surgeon and hospital. SpineGuard’s primary objective is to establish its PediGuard device as the global standard of care for safer screw placement in spine surgery.

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THURSDAY, FEBRUARY 5 , 2015 MEDICAL DEVICE DAILY™ EXTRA PAGE 1 OF 2

ORTHOPEDICS EXTRAONCOLOGY EXTRAKeeping you up to date on recent developments in orthopedics By Holland Johnson, Executive Editor

Continues on next page

Minimally invasive treatment corrects spinal curvature in children

Adolescent idiopathic scoliosis (AIS) affects 2%-3% of children aged between 10 and 16. It is more common in girls than in boys (with a ratio of 10-1). Besides the obvious physical signs derived from the visible spinal deformity, AIS can cause psychological and emotional problems (low self-esteem, poor self-image body, etc.) that significantly reduces patients’ quality of life.

Although bracing has been basic in non-surgical treatments for AIS for almost fifty years, some studies suggest that this technique is able only to stop the curve progression, but cannot reduce the deformity. Furthermore, bracing often conditions or boosts psychological disorders in patients wearing the brace for a long period of time.

Patients developing high magnitude spinal curves or those who show a rapid and significant curve progression, often require a very aggressive surgery. More than 4,000 European adolescents undergo this procedure each year with the risk of long term side effects.

“Surgery corrects the curve deformity, but fuses the spine, eliminating its function. The long term consequences of spinal fusion cause several complications,” said Professor Carlos Barrios, director of the Institute for Research on Musculoskeletal Disorders of the Universidad Católica de Valencia, Spain. “Efforts are currently being made to find techniques that do not involve extensive spinal fusion to correct the scoliotic deformity, preserving the physiological range of motion of the spine.”

A high proportion of diagnosed patients are normally subject to mere observation, without receiving specific therapy. However, if the disease is diagnosed late or develops faster than anticipated, current medical practice only has treatments with brace or surgery, each one with its drawbacks.”

Recent studies provide evidence that suggest possibilities for alternative treatments. “Recent findings show that AIS is a musculoskeletal expression of a central nervous system disorder, in other words a neurological disease,” explained Barrios.

“Neurological dysfunction affects deep paraspinal muscles inducing an imbalance of forces acting on the vertebral segments.” The StimulAIS Project is based on this research. The initiative is supported by an international consortium of businesses, research institutes and universities and aims at introducing alternative AIS treatments based on electrical muscle stimulation of deep paraspinal rotator muscles - a technique known as functional electrical stimulation.

The consortium consists of three SMEs: the Project coordinator Tequir S.L. (Spain), Synergie Ingeniere Medicale SARL (SYNIMED, France) and Bentronic Gesellschaft Für Medizintechnik GMBH (BENTRONIC, Germany), as well as three

reference research centers: the Instituto de Biomecánica de Valencia (IBV, Spain), the Universidad Católica de Valencia (UCV, Spain) and Fraunhofer-Gesellschaft zur Förderung der Angewandten Forschung E.V. - IPMS (IPMS, Germany). Uniting their expertise, the project has developed the first prototypes of the device that provides the FES treatment.

As a spokesperson of Tequir, a Spanish company that specializes in innovative medical technologies in the fields of spinal medicine, orthopaedics and traumatology, explains, “The unit should provide personalized treatments. It is primarily aimed at not only inhibiting the curve progression, but also potentially correcting it significantly.”

To achieve this, the project has developed an implantable device to sense and stimulate the key muscles as well as the integrated stimulation control software to modulate it into safety thresholds. To implement the device subcutaneously, the team has developed minimally invasive surgical instruments.

The findings obtained in the research phase have been incorporated into a stimulation protocol which allows real-time adaptation to the data received and therefore the treatments are more effective.

Depuy Synthes Spine announces expanded indication for Synapse OCT system

DePuy Synthes Spine (Raynham, Massachusetts) reported it has received 510(k) clearance from the FDA to market its Synapse Occipital-Cervical-Thoracic (OCT) System with posterior cervical screws, the first time cervical screws have been indicated for use with a screw-rod posterior fixation system. Previously, screw placement in this system was limited to use for fixation in the thoracic spine (T1-T3) and occiput only. DePuy Synthes Spine is a part of the DePuy Synthes Companies of Johnson & Johnson (New Brunswick, New Jersey).

“This is very exciting news as it will allow us in the surgeon community to further drive education and research on these important techniques. Additionally it enables us to work with companies like DePuy Synthes to create new, innovative solutions to help improve patient care in the posterior cervical space,” said Todd Albert, Surgeon in Chief and Medical Director Korein-Wilson Professor of Orthopaedic Surgery, Hospital for Special Surgery, Weill Cornell Medical College.

“This expanded indication is significant in that DePuy Synthes Spine is now able to sponsor education on the technique and contribute to a greater understanding of its use in treating conditions of the cervical spine,” said Karen Rowley, Franchise Unit Leader, Spine. “As a company, we continue to pioneer new techniques, expand our portfolio of comprehensive solutions and provide industry leadership in education, research and innovation.”

THURSDAY, FEBRUARY 5 , 2015 MEDICAL DEVICE DAILY™ EXTRA PAGE 2 OF 2

ONCOLOGY EXTRAORTHOPEDICS EXTRAContinued from previous page

The Synapse OCT System, including Synapse, OC Fusion and AXON, is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

First gene responsible for familial scoliosis identified The discovery of the first gene causing familial scoliosis

has been announced by an international France-Canada research team. “Mystery surrounds the cause of scoliosis, which is a three dimensional deformation of the vertebral column. Many researchers have been attempting to uncover the origins of this disease, particularly from a genetic point of view,” explained leading co-author Florina Moldovan of the University of Montreal (Quebec) and the CHU Sainte Justine research hospital. “To date, many genes have been suspected of causing scoliosis among different populations, but the gene that causes the familial form of the disease remained unknown. Our discovery of this first causative gene is due to the support of the Fondation Yves Cotrel and our international teamwork, in particular with leading co-author Dr. Patrick Edery of CHU de Lyon hospital and Dr. Pierre Drapeau of the CRCHUM.”

A variation in the POC5 gene was initially identified by DNA sequencing (exome sequencing) in the samples Patrick Edery collected from a large French family, of whom several members are affected by idiopathic scoliosis. Others variants of the POC5 gene were detected in scoliotic families and in people whose scoliosis had no precedence in their families. “The POC5 gene encodes for a centrosomal protein involved in microtubule-organising centres and cellular polarity,” explained first author Dr. Shunmoogum (Kessen) Patten, who undertook his post-doctoral work at the CHU Sainte-Justine and CHUM research centres. “The pathogenicity of POC5 variants was documented by using the zebrafish, a well-established genetic animal model that has a spine.” This model revealed that the over-expression of mutated human POC5 gene led to the rotational deformation of the anterior-posterior axis of the spine in half of the zebrafish embryos. The deformations are similar to the deformations observed in scoliosis patients.

The data suggest that the mutations are dominant, confirming the human genetic analysis. Interestingly, the protein is strongly expressed in the brain, within very precise structures in the midbrain. This leads the research team to believe that there is an association between the brain and idiopathic scoliosis.

Weight loss of 10% or more in seniors significantly raises hip fracture risk

While a low body mass index (BMI) of less than 20 kg/m2 has been shown to be an independent risk factor for hip fractures, far less is known about the relationship of body weight changes on hip fracture risk.

The findings of a new study presented at the IOF Regionals Asia-Pacific Osteoporosis Meeting in Taipei, show that among middle-aged to elderly Singapore Chinese, weight loss of 10% or more was associated with a 56% higher hip fracture risk.

The researchers used data from the Singapore Chinese Health Study, a population-based cohort of 63,257 Chinese men and women aged 45-74 years at recruitment (1993-1998). After an average of 5.7 years, the researchers conducted a follow-up interview (1999-2004) among 52,322 surviving subjects in the group studied.

A total of 775 incident hip fracture cases were identified from the follow-up interview until Dec. 31, 2010 [interval of 9.0 years]. The mean age at hip fracture was 75.3 years.

Compared to subjects with stable weight (loss or gain less than 5%), those with weight loss of 10% or more had a 56% increase in hip fracture risk, and the elevated risk was present in both men and women. Even after accounting for health conditions and follow-up BMI subsequent to the weight change, those with weight loss of 10% or greater still had a 39% increase in hip fracture risk.

The increase in risk for those who had lost 10% or more in weight was more prominent in those subjects whose baseline BMI was equal to or greater than 20 kg/m2, but it was not observed in those who were already very lean at recruitment (baseline BMI< 20 kg/m2). In fact, subjects who were overweight at recruitment (BMI>25 kg/m2) and subsequently lost 10% or more in weight had the greatest increase in risk.

Overall, weight gain was not associated with hip fracture risk. Although weight gain equal to or greater than 10% appeared to reduce hip fracture risk in those with a baseline BMI ≤ 25 kg/m2, the association was not statistically significant.

Lead author, Zhaoli Dai of the Saw Swee Hock School of Public Health, National University of Singapore, said, “The results of this study suggest that doctors should be alert to the need to identify and manage the risk in patients who have experienced substantial weight loss. Hip fractures are a major cause of disability and premature death in seniors, and it is therefore important that preventive action be taken in patients who are at high risk.”

MEDICAL DEVICE DAILY’S PATENT HIGHLIGHTS

FROM CORTELLIS’ PATENTS GAZETTE WEEK 04 DEVICES AND EQUIPMENT

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The Patents Gazette provides snapshot analysis and indexing of pharmaceutically relevant patenting within days of its publication by patent offices. Primarily focusing on material from the main three patents offices (ie the EPO, USPTO, and WIPO), it provides brief descriptions of a patent’s content and seeks to link it to both prior patenting of relevance and to any commercial activity pertinent to the technology being described.

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Medical Device Daily™ - Cortellis™ Patent Gazette

MDD-CPG Week 04

2

WO2015013009-A1: “Infusion pump including reverse loading protection.” Assignee: Baxter International Inc; Baxter Healthcare SA

Inventors: Zhu, Hong

IPC Codes: A61M 5/142

Publication Date: 29-Jan-2015

Earliest Priority Details: US2013947193, 22-Jul-2013

Infusion pump comprising an occlusion sensor that may be configured to detect reverse loading of the tubing to the pumping mechanism and consequently cause the motor to turn off. The occlusion sensor may also cause the triggering of an alarm and/or prevention of the operation of the pumping mechanism, when it does not detect the tubing mounted on the pumping mechanism. An optional misload sensor can be configured to detect the tubing when the tubing is properly loaded on the pumping mechanism. Valves associated with the pump’s pumping fingers are configured to occlude the tubing. The filing’s disclosure states how the infusion device may be a small portable pump or a larger pump (such as that disclosed within US5018945), which could indicate its possible application to Baxter’s electronic bedside

Colleague infusion pumps.

For prior patenting from Baxter on its infusion pump technologies, see WO2014158434 describing a pump system for individualized healthcare use which comprises an infusion pump, a display, an input interface, and a pump controller.

Baxter has also been the exclusive distributor of the SIGMA Spectrum Infusion System for three years and recently completed the acquisition of its manufacturer, SIGMA International. The SIGMA Spectrum Infusion System was designed with features to help reduce errors when programming an IV infusion. For example, the SIGMA Spectrum Infusion System automatically defaults to using the drug safety library at the initial start of the system.

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MDD-CPG Week 04

3

WO2015011151-A1: “Adaptor for a needleless access device and method for connecting said device thereon.” Assignee: Becton Dickinson France SA

Inventors: Devouassoux, Thomas; Hallynck, Sylvain; Maritan, Lionel; Wools, Robin

IPC Codes: A61M 5/34; A61M 39/10

Publication Date: 29-Jan-2015 (also published as EP2829297-A1, 28-Jan-2015)

Earliest Priority Details: EP2013306066, 23-Jul-2013

Adaptor for connecting a drug delivery device to a needleless access device comprising a globally tubular body, a straight internal and an external thread. Useful for connecting an IV line to a drug delivery device. The applicants have found that a decrease of the diameter on a proximal part of the length of the internal thread allows better radial interferences between the adaptor and the needleless access device, yet without requiring that a higher torque be exerted for screwing the needleless access device into the adaptor, compared to adaptors of the prior art.

The above figures provide a cross sectional view of an adaptor of the invention, along with an exploded perspective view of the connection of a needleless access device to a drug delivery device via the adaptor. Follows WO2014057071, describing an improved adaptor, eg a Luer lock adaptor, for use with a drug delivery device.

Becton Dickinson’s BD Q-Syte™ Luer Access Split System is a needleless IV access device designed to help minimize the potential for contamination and reduce the risk of accidental needlestick injuries. The closed system can help to reduce the risk of cannula-related bloodstream infections and is designed for use on ISO Standard IV medical devices and the connection and disconnection of syringes and IV sets.



MDD-CPG Week 04

4

US20150032102-A1: “Catheter with integrated flow sensor.” Assignee: Biosense Webster

Inventors: Ephrath, Yaron; Feldchtein, Mikhael; Govari, Assaf; Kiselman, Alexander

IPC Codes: A61B 18/14



Catheter with integrated flow sensor comprising a distal segment and an ablation electrode. Useful for monitoring the flow rates of irrigation fluid within an invasive probe within the body, such as a cardiac catheters being used to treat cardiac arrhythmias. Follows EP2777589 claiming catheters that are configured to irrigate tissue during cardiac ablation, and also see EP2777585 describing a force feedback device for cardiac ablation catheters.

In February 2014, Biosense Webster announced it had received approval from the US FDA for its THERMOCOOL® SMARTTOUCH® Catheter. At that time it was the first therapeutic catheter approved in the US to enable direct and real-time measurement of contact force during catheter ablation procedures for patients suffering from drug-resistant paroxysmal atrial fibrillation, sustained monomorphic ischemic ventricular tachycardia and Type I atrial flutter.



MDD-CPG Week 04

5

WO2015013515-A2: “Driving patient compliance with therapy.” Assignee: Boston Heart Diagnostics Corporation

Inventors: Schaefer, Ernst, J.

IPC Codes: G01N 33/92; C12Q 1/60

Publication Date: 29-Jan-2015 (also published as US20150031058-A1)


Methods for determining compliance with a cholesterol lowering therapy (preferably treatment with ezetimibe) comprising assays to determine levels of a cholesterol biomarker and of cholesterol before and after the therapy. Continues from WO2014052790, claiming methods for determining suitability of a patient for cholesterol lowering therapy.

These applications may refer to some of the “exclusive tests” mentioned on the company website, which form part of the

“Boston Heart Lifestyle Program”, a set of personalized recommendations for improvement of lifestyle.

On February 2, 2015, Eurofins Scientific, a provider of bio-analytical testing and genomic services, announced the successful closing of an agreement to acquire Boston Heart following approval from regulatory authorities. The initial fee is expected to be $140 million, plus earn-out payments in excess of $60 million.



MDD-CPG Week 04

6

US20150032046-A1: “Energy-based treatment methods for refractory gout.” Assignee: Covidien LP

Inventors: Ross, Anthony B.; Nau, Jr., William H.; Van Tol, David J.; Deborski, Christopher A.

IPC Codes: A61F 7/00; A61B 17/22; A61N 5/02; A61N 5/00; A61M 1/00



Methods and apparatus for delivering mechanical and/or electrical energy to a tissue, particularly a joint, at a predetermined frequency which resonates with uric acid (UA) crystals. Some of the UA are debulked and can then be removed. Useful for the treatment of refractory gout in a minimally invasive or non-invasive way.

See WO2015009345 from Covidien, published a week earlier, describing a surgical instrument for delivering energy to a tissue.



MDD-CPG Week 04

7

US20150032198-A1: “Methods and apparatus for luminal stenting.” Assignee: Covidien LP

Inventors: Folk, Chris

IPC Codes: A61F 2/966



Stent delivery assemblies comprising a catheter with a lumen, a dual layer cover member, a core member, a stent, and a stent retention mechanism. The assemblies allow a clinician to reposition the stent within a vessel after initial positioning.

For a previous filing from Covidien on stents, see WO201415260. These applications may refer to the EverFlex™ Self-Expanding Peripheral Stent System listed on the company website. This is indicated for use in the superficial femoral artery and/or the proximal popliteal artery.



MDD-CPG Week 04

8

WO2015011455-A1: “Medical device.” Assignee: Grant, Susan

Inventors: Grant, Susan

IPC Codes: A61F 7/10; A61F 7/02; A61F 7/08


Earliest Priority Details: US 2013857779, 24-Jul-2013

The application describes a bag containing seeds or grains and of a size and shape to cover both eyes. When used, it is placed in an outer cover which has straps and enables the positioning of the bag on the head of the patient. The seeds may be heated or cooled before use. The device is disclosed to be useful in alleviating eye conditions including styes, dry eye and meibomian gland dysfunction. The application follows GB2514594 describing a similarly constructed glove or sock.

The inventor appears to be associated with Blooming Surprise and the present application appears to cover the company's The Eye Doctor product as shown on the company website.



MDD-CPG Week 04

9

WO2015013450-A1: “Computer-based analysis of oscillatory ventilation.” Assignee: Mayo Foundation For Medical Education And Research

Inventors: Johnson, Bruce D; Olson, Thomas P

IPC Codes: A61B 5/00


Earliest Priority Details: US2013858487, 25-Juk-2013

The application describes a computer-based analysis of oscillatory ventilation which provides up-to-date, on demand and real time interpretation of respiratory profiles of a patient and is useful for assessing a patient's cardiac and/or pulmonary function.



MDD-CPG Week 04

10

US20150032053-A1: “Titration for medical infusion devices and systems.” Assignee: Medtronic, Inc.

Inventors: Schmitz, Michael C; Seeley, Dale F; Hildebrand, Keith R

IPC Codes: A61M 5/168



The application describes one or more infusion device(s) comprising a drug reservoir, a pump driving the drug from the reservoir to the patient, an input apparatus which receives an input indicative of a patient side-effect to the drug, and control electronics connected to the pump mechanism and the input apparatus. The device is useful for titrating the drug and accounts for patient side-effects in controlling the rate at which a drug eg insulin is delivered. See also WO2014197123 from a different team at Medtronic and describing devices for programming implantable infusion systems.

The present application may refer to Medtronic's MiniMed's Paradigm insulin pumps or their Synchromed infusion pumps.



MDD-CPG Week 04

11

WO2015013716- A1: “Patient-specific temporary implants for accurately guiding local means of tumor control along patient-specific internal channels to treat cancers.” Assignee: The Regents Of The University Of California

Inventors: Pouliot, Jean; Goldberg, Ken; Hsu, I-Chow; Cunha, J, Adam M; Garg, Animesh; Patil, Sachin; Abbeel, Pieter; Siauw, Timmy

IPC Codes: A61N 5/10



A removable implantable device designed to be positioned proximal to a tumor and having in it one or more channels capable of carrying and localizing tumor therapy is described. The device is preferably 3D printed and the therapy is preferably brachytherapy. The device may be designed from diagnostic images obtained from the patient for whom it is intended and provides a higher number of dwell positions than conventional devices.

The above image shows an intra-cavitary high dose rate brachytherapy gynecological applicator, and the filing’s disclosure includes the results of a study in which 3D printed technology was used to print custom applicators for patients undergoing undergoing gynecologic brachytherapy. It reports that 3D printing can enable the production of applicators with excellent fit and optimized interstitial needle placement to enable target coverage, normal tissue sparing, and implant stability.


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