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. Nevro surges on Senza approvable letter from FDA
Shares of Nevro Corp. surged nearly 17% today after the company said it received an “approvable letter” from the FDA for its Senza spinal cord stimulator for chronic pain, signaling a sooner-than-expected approval for the U.S. market.
The Senza device is designed to deliver up to 10,000Hz to the spinal cord; Nevro says previous trials demonstrated that its HF10 therapy is nearly twice as successful in treating back pain as traditional SCS devices, which typically deliver between 40Hz and 60Hz. Read more
2. Medtronic wins HDE for Enterra II neurostim device
Medtronic said it won a humanitarian device exemption for its Enterra II device, a neurostimulation implant designed to treat the stomach disorder gastroparesis.
The stomach muscles of patients with gastroparesis function poorly or not at all, preventing it from emptying and interfering with digestion. The Enterra II device is designed to treat the nausea and vomiting that often accompanies gastroparesis in patients who can’t take drugs to treat the condition, Medtronic said, noting that about 5% of diabetics are estimated to suffer from gastroparesis. Read more
1. Medtech approvals: FDA releases October 2014 PMAs
The U.S. Food & Drug Administration releases a list of pre-market approvals granted in October 2014. Read more
