Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 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.
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5. St. Jude Medical’s HeartMate 3 implantable pump beats HeartMate II in pivotal trial
The next-generation HeartMate 3 implantable pump St. Jude Medical acquired when it paid $3 billion for Thoratec last year proved superior to the older HeartMate II device at 6 months in pivotal clinical trial results released today.
The Momentum 3 study enrolled more than 1,000 patients for a short-term outcome after 6 months and a longer-term, 2-year outcome; the initial 6-month data comes from 294 subjects. Unlike the HeartMate II device, which uses an axial-flow pump, the HeartMate 3 device uses a centrifugal-flow pump designed to reduce the risk of blood clots. Read more
4. PwC California Life Sciences report highlights continued investment, growth
The California Life Sciences Assn. and PricewaterhouseCoopers released their annual Life Sciences Industry Report, highlighting continued growth and a robust pipeline of medical devices and other therapies in California this year.
California, which is ranked 1st for medical device and biopharmaceutical employment in the country, saw 7% employment growth in the sector between 2011 and 2015. In 2015, there were more than 3,000 life science companies in the state and nearly 300,000 employees in the industry. Read more
3. Endologix shares dive on FDA request for more Nellix data
Endologix shares are off nearly -25% today after the company said the FDA asked for more data on its Nellix stent graft for treating abdominal aortic aneurysms.
Irvine, Calif.-based Endologix said the federal safety watchdog wants 2-year follow-up data from its EVAS-Forward investigational device exemption study. The additional data submission, expected during the 2nd quarter of 2017, pushes potential pre-market approval from the FDA back to the 2nd quarter of 2018, Endologix said. Read more
2. Report: EU regulators poised to OK Abbott’s $25B St. Jude Medical acquisition
Antitrust regulators in the European Union are reportedly poised to give conditional clearance to the $25 billion merger of Abbott and St. Jude Medical.
The European Commission has until next week to make its decision on the deal, after the companies earlier this month made concessions designed to assuage the commission’s monopoly fears. Abbott and St. Jude agreed last month to deal some of their vascular assets to Japan’s Terumo Corp. (TYO:4543) for $1 billion. The merger, announced in April, is slated to close by the end of this year. Read more
1. FDA expands indication for Medtronic’s Solitaire stent retriever
Medtronic said today that the FDA granted 510(k) clearance for an expanded indication for its Solitaire stent retriever.
The new indication covers its use as an initial treatment for acute ischemic stroke after the administration of intravenous tissue plasminogen activator and within six hours of symptom onset, Fridley, Minn.-based Medtronic said. The Solitaire device is designed to remove clots from brain arteries using a micro-sized catheter. Read more
The post MassDevice.com +5 | The top 5 medtech stories for November 16, 2016 appeared first on MassDevice.
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