MassDevice.com +3 | The top 3 medtech stories for November 19, 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. St. Jude Medical wins FDA approval for Proclaim Elite spinal cord stim device

St. Jude Medical said today that it won FDA approval for its Proclaim Elite spinal cord stimulation device for treating chronic pain.

Little Canada, Minn.-based St. Jude claimed the device as the sole U.S.-approved upgradable and recharge-free SCS system, noting that the federal safety watchdog also approved conditional MR labeling for the Proclaim Elite for head and extremity scans. Read more

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2. Diabetes: Fractyl Labs closes $57m Series C round

Fractyl Laboratories said today that it closed a Series C round worth $57 million with a final, $17 million tranche joined by new backer Deerfield Management, as it readies its Retiva device for a Phase II trial.

Waltham, Mass.-based Fractyl calls the Retiva a “duodenal mucosal resurfacing” device; it’s designed to separate the mucosa and sub-mucosa in the duodenum before ablating the mucosa to help regulate insuling production in Type II diabetics. A 39-patient proof-of-concept study showed results that were comparable to bariatric surgery, according to the company. Fractyl began enrollment in the Revita-1 Phase II trial in July. Read more

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1. FDA puts CVRx’s BaroStim heart failure treatment on the fast track

CVRx said that it won a fast-track designation from the FDA that could shave 1 or 2 years from the timeline to approval for its Barostim Neo heart failure treatment.

The Barostim Neo device is a neurostimulation implant designed to treat heart failure by influencing both the sympathetic and parasympathetic nervous systems, reducing sympathetic activity and increasing parasympathetic activity. The Minneapolis-based company said the FDA put its Beat-HF pivotal trial on its “expedited access pathway,” created in April as an alternative to pre-market or de novo approval for devices designed for conditions with no other treatments. Read more

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