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. J&J investor relations veep Mehrotra retires, Wolk steps up
Johnson & Johnson said today its 10-year vice president of investor relations Louise Mehrotra will retire, effective January 2017, to be replaced by Joseph Wolk, effective August 1.
Wolk previously served as vice president of group finance for Johnson & Johnson’s pharmaceuticals deivision, and has held other finance leadership positions prior to that, the company said. Read more
4. Five-year TAVR data reassure on durability
Five-year data from a clinical trial of early transcatheter aortic valve replacements showed good durability, allaying concerns raised by a study last month in which more than a third of the valves deteriorated significantly over that span.
Results from the Partner clinical trial, presented last week at the Transcatheter Valve Therapies conference in Chicago, showed a much lower mean gradient (the change in pressure across the valve) than were found in a smaller study presented in May at the annual EuroPCR meeting in Paris. The researchers behind that study predicted that as many as half of all 1st-generation TAVR devices, like the Edwards Lifesciences Sapien valve, would show signs of deterioration within 8 years. Read more
3. FDA warns Medtronic’s Tyrx on anti-bacterial envelopes
The FDA sent a warning letter earlier this month to Medtronic subsidiary Tyrx over problems with its process validation and quality systems.
The Tyrx envelopes are designed to elute a pair of anti-microbial drugs, minocycline and rifampin, for 7 days before dissolving over a period of roughly 9 weeks. They’re cleared for use with pacemakers, implantable cardioverter-defibrillators, cardiac resynchronization therapy devices, deep-brain stimulators, sacral nerve stimulators, spinal cord stimulators and vagus nerve stimulators. Tyrx, which Medtronic acquired for $160 million in January 2014, won CE Mark approval in the European Union for use with cardiac devices in September 2014. Read more
2. India’s new medical device regulations to drop ‘shortly’
Regulators in India are close to releasing new rules governing the medical device industry there, as the world’s 2nd-largest country prepares to create a separate set of regulations for medtech.
India’s Ministry of Health & Family Welfare is looking to make it easier for medical device and pharmaceutical companies to do business there, while ensuring the safety and efficacy of the products. Today the government there said it’s scrapping legislation introduced in 2013 to reform its Drugs & Cosmetics Act as it focuses on crafting separate tracks for the medtech industry. Read more
1. Trump’s ‘Mad Men’ are also medical device execs
The “Mad Men” behind the Draper Sterling firm that got $35,000 from Donald Trump’s presidential campaign are reportedly also the co-founders of medical device company XenoTherapeutics.
Campaign finance documents released this week showed that the Trump campaign paid $35,000 to Londonderry, N.H.-based Draper Sterling; the name is a play on the names of 2 characters on the popular Mad Men television program. Paul Holzer and Jonathan Adkins, the duo media outlets linked with Draper Sterling, are also behind Boston-based XenoTherapeutics; Trump’s campaign also paid $3,000 each to Holzer and Adkins, apart from the payment to Draper Sterling. Read more
The post MassDevice.com +5 | The top 5 medtech stories for June 22, 2016 appeared first on MassDevice.
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