Ethicon takes on ‘diabesity’ with $3m research program

Johnson & Johnson’s(NYSE:JNJ) Ethicon subsidiary said today that it’s dropping $3.2 million on a research program on the effects of early surgical intervention on obesity and Type II diabetes.

Cincinnati-based Ethicon said its “Time to Act on Obesity” program involves more than 20 clinical trials enrolling some 2,000 patients and investigator-initiated studies in 5 countries.

“We know that metabolic disease has reached pandemic proportions, as nearly 30% of the world’s population is overweight or obese. We are calling our commitment, our rallying cry, It’s Time to Act on Obesity. And, if ever there’s a time – a tipping point, when we can make a difference – it’s now,” Ethicon chairman Michael del Prado said in prepared remarks. “Ethicon will continue working to reverse the trajectory of obesity by connecting the brightest clinical researchers and surgeons with our unparalleled science, economic insights and global reach to find long-term solutions.”

The program also includes studies on the economic impacts of bariatric and metabolic interventions, Ethicon said.

“The ultimate questions we’re always seeking to answer are: Who is the right patient, what is the right procedure, and is this the right time?” medical director for obesity & metabolic disease Dr. Elliott Fegelman said in prepared remarks. “In the U.S., the term ‘diabesity’ is gaining popularity because of the inextricable link between Type II diabetes and obesity. That’s the reverse of what we know to be true in Asia. For example, in China, they’re recording upwards of 114 million patients who have uncontrolled Type 2 diabetes, but develop it much earlier on the BMI curve, meaning they’re not as obese. We don’t see that same level of interdependence – that perceived cause-and-effect in Asia, between obesity and diabetes. These regional nuances, as we look across the U.S., Asia, Europe and Latin America, all require different and distinctive solutions, and that’s what our investment will help deliver.”

Ethicon said it’s looking to address a similar issue in India, where patients with uncontrolled diabetes also have lower BMI rates. In France, the program will aim to generate clinical and economic data to back guidelines for bariatric surgery. In Brazil, where patients can wait 7 years for bariatric and metabolic surgeries, Ethicon will study the cost and health impact of delayed treatment. The U.S. portion of the program will evaluate the durability of remission of co-morbidities like Type 2 diabetes after bariatric and metabolic interventions, the company said.

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Hong Kong regulators issue list of recognized standards for medical devices

By Stewart Eisenhart, Emergo Group

Regulators in Hong Kong have published a new list of recognized standards applicable to medical devices as the region moves toward more formal oversight of its device market.

The Hong Kong Medical Device Control Office’s (MDCO)list is intended as a reference for in-country representatives (Local Responsible Persons) in order to demonstrate safety and effectiveness of their manufacturers’ products.

The MDCO list includes standards from the International Standards Organization (ISO) and International Electrotechnical Commission (IEC). MDCO has included ISO 15223 for medical device symbols, but not EN 980, an older standard for device symbols.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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AHA/ASA updates stroke treatment guidelines

The American Heart Association/American Stroke Association said today that it updated its treatment guidelines for patients suffering from ischemic stroke to include endovascular treatments.

The decision supports the use of stent retrieval, and other thrombectomy devices, used to remove clots in patients who have obstructions in the large arteries supplying blood to the brain according to a new focused update published in the American Heart Association journal Stroke.

The AHA/ASA said that optimal treatment still lies with the intravenous use of tissue plasminogen activators, used to break down clots, but recommends the use of retrieval devices in cases where obstructions continue after the medication has been administered.

“What we’ve learned in the last 8 months, from 6 new clinical trials, is that some people will benefit from additional treatment with a stent retrieval device if a clot continues to obstruct one of the big vessels after tPA is given,” update lead author Dr. William Powers of the University of North Carolina at Chapel Hill said in a press release.

The decision was based upon the results of randomized clinical trials, such as Penumbra‘s Mr Clean trial, published since 2013 when the last treatment guidelines were issued.

“We are pleased that the American Heart Association/American Stroke Association updated their acute ischemic stroke treatment guidelines to support the endovascular treatment of stroke patients. This is another step forward for those patients who can benefit from mechanical thrombectomy as shown by the landmark Mr Clean study and subsequent confirmatory trials that support endovascular treatment over medical management alone,” Penumbra CEO Adam Elsesser said in a press release.

The update suggests a preference for stent retrievers over other mechanical thrombectomy devices, but adds that the use of other devices may be reasonable based upon a physician’s clinical judgement.

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MassDevice.com +3 | The top 3 medtech stories for June 29, 2015

Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

 

3. Medtronic wins aortic valve patent spat with inventor

Medtronic won a patent infringement dispute over its CoreValve aortic valve replacement with inventor Dr. Troy Norred, according to legal filings.

The district court case, filed by Norred in 2013, had received stays until an inter partes review could examine the patent case, according to legal filings. The 3 judge panel reviewing the case found 7 of Norred’s claims were unpatentable, upholding Medtronic’s challenge to the patent. Read more

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2. Integra LifeSciences picks up TEI Biosciences, TEI Medical for $312m

Integra LifeSciences said that it agreed to acquire TEI Biosciences and sister company TEI Medical for $312 million in cash in a bid to expand its footprint in reconstructive surgery and regenerative wound care.

The deal, expected to close during the 3rd quarter, brings TEI’s PriMatrix dermal repair scaffold and a 125-member sales force under the Integra umbrella, that Plainsboro, N.J.-based company said. TEI is based in Waltham, Mass. Read more

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1. Ex-OtisMed CEO Chi draws 2 years

The former CEO of Stryker subsidiary OtisMed, Charlie Chi, drew a 2-year prison sentence after pleading guilty to distributing knee replacement surgery cutting guides without FDA clearance, the safety bureau and federal prosecutors said.

Stryker inherited the beef when it acquired OtisMed in 2009, later offering to pay $33 million to settle the federal investigation. The misconduct occurred before the acquisition and “without Stryker’s prior knowledge or acquiescence,” the prosecutors said. The company agreed to pay $80 million late last year to settle its part of the case, with Chi pleading guilty on 3 counts. Read more

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DoJ closes Abiomed Impella 2.5 investigation

Abiomed (NSDQ:ABMD) said today that the U.S. Department of Justice has closed an investigation into the marketing of the company’s Impella 2.5 heart pump without taking any enforcement action.

The investigation began in October 2012 when Danvers, Mass.-based Abiomed said it was informed that the U.S. Attorney’s Office of the District of Columbia had initiated an investigation.

The DoJ informed the company it was seeking internal documents relating to Abiomed’s marketing and labeling of the Impella 2.5, the company said. Abiomed said it cooperated fully with the inquiry.

“We are pleased that the Department of Justice has chosen to close its investigation without pursuing any further action and that this matter is now behind us.  We have always remained steadfast in our integrity and our commitment to putting our patients first,” CEO Michael Minogue said in a press release.

The Impella 2.5 is a percutaneous “micro heart pump” with integrated motor and sensors, which the company bills as the world’s smallest heart pump.

Abiomed won pre-market approval from the FDA for its flagship Impella 2.5 in March, after the FDA’s Circulatory Devices panel recommended in late 2012 that percutaneous cardiac assist devices be subject to the FDA’s most stringent PMA protocol. The pump had been allowed on the U.S. market via the FDA’s less-stringent 510(k) clearance protocol.

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Bard touts publication of Lutonix study in NEJM

C.R. Bard (NYSE:BCR) said last Thursday that a 2-year study of its Lutonix drug-coated balloon catheter was published in The New England Journal of Medicine.

The 2-year Levant 2 study data showed non-inferiority of the device and a trend towards superiority, compared to standard percutaneous transluminal angioplasty, in the treatment of peripheral artery disease, the company said.

“We want to thank the investigators involved in the Levant 2 trial for their authorship of this ground-breaking study. Publication of the study results in The New England Journal of Medicine demonstrates the high quality of the trial and the importance of the results,” CEO Timothy Ring said in a press release.

“The publication of these data in the prestigious New England Journal of Medicine reinforces not only the superior results for Lutonix 035 DCB compared to standard PTA, but also the rigor of the clinical trial. This should provide additional confidence to clinicians looking to use a drug coated balloon in treating PAD in the femoropopliteal arteries,” Bard senior veep of science, technology & clinical affairs Dr. John DeFord said in a prepared statement.

The study, released earlier this month, showed 78.7% composite safety scores at 2 years, primary patency of 58.6%, an 82% rate of freedom from target lesion revascularization and a 6.9% rate of death.

“Levant 2 followed a rigorous blinding protocol, which was designed to reduce bias in the results. In addition to superiority in primary patency, the paclitaxel-coated balloon used in the study also demonstrated sustained improvements in Rutherford category from baseline to 12 months, and improved patient-reported walking distance scores,” principal investigator Dr. Kenneth Rosenfield of Boston’s Massachusetts General Hospital said in prepared remarks.

Earlier this month, Bard said that the U.S. Centers for Medicare and Medicaid Services had improved the payment for Bard’s Lutonix drug-coated balloon catheter through the Medicare hospital outpatient prospective payment system.

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Kips Bay Medical pulls the plug

Kips Bay Medical (OTC:KIPS) said last week it will be liquidating the company after terminating the Emesh I clinical feasibility trial of its eSVS mesh based on poor 6-month results.

The company’s board of directors unanimously approved a plan to dissolve the company and return any remaining cash to its stockholders, Minneapolis, Minn.-based Kips Bay said.

Kips Bay said it has $2 million in cash and cash equivalents which the company estimates will be sufficient to “pay off all of its current and anticipated liabilities and to conduct an orderly wind down of its operations,” according to a press release.

The 106-patient Emesh 1 study looked at external saphenous vein graft supports, using the company’s device, and returned poor 6-month angiographic results for the first 26 patients implanted using a new surgical technique, the company said.

The eSVS mesh is designed to keep vein grafts open during in coronary artery bypass graft surgeries, and is composed of a flexible sleeve that fits around the outside of the vein to reduce vessel wall stress and mitigate the potential for vessel injury.

“We are, needless to say, extremely disappointed with the poor 6-month angiographic results from the new technique patients. We had hoped the new technique would reduce or prevent the resulting injury which can lead to SVG failure and potentially costly and complicated re-interventions for patients undergoing CABG surgery. I would like to thank the patients who participated in this study as well as our clinical trial investigators and their teams. I am also very appreciative of our employees, to many of whom we must now sadly say goodbye and for the continued support and loyalty of our stockholders,” CEO Manny Villafaña said in prepared remarks.

Last month Kips Bay said it was considering closing shop after initial results failed to meet a last-ditch bar set in March.

In March Kips Bay turned to founder, chairman & CEO Manny Villafaña and other backers for a private placement worth up to $3.25 million. The deal called for the investors to put the cash up in 4 equal tranches, but not before the Emesh I trial generates 10 angiograms from eSVS-treated patients demonstrating that it’s “advisable for the company to continue with the Emesh I clinical feasibility trial and to continue to pursue marketing approval by the FDA for the eSVS mesh,” Kips Bay said in March.

In September 2011 the FDA issued a non-approvable letter for the device, asking for more information on the eSVS mesh before granting permission for a feasibility study. That approval came in November 2012 and was later expanded. In March, Kips Bay, which let its listing on the NASDAQ exchange expire last September, said it reached the enrollment goal for the Emesh I feasibility study.

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