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. NuVasive wins FDA nod for X-Core cervical corpectomy cage
NuVasive Inc. said that it won 510(k) clearance from the FDA for its X-Core mini cervical corpectomy cage, claiming it as the 1st such device cleared for the U.S. market.
The X-Core device is designed to replace vertebrae in the cervical spine (C3 to C7), San Diego-based NuVasive said. It must be used with supplemental fixation such as the company’s Archon Reconstruction corpectomy plate. Read more
2. St. Jude Medical wins CE Mark for HeartMate 3 pump
St. Jude Medical said that its newly acquired HeartMate 3 implantable heart pump won CE Mark approval in the European Union, less than a week after the medical device company closed its $3 billion acquisition of Thoratec.
HeartMate 3, a left ventricular assist device, is designed for heart failure patients who are awaiting a transplant, aren’t eligible for a transplant or are in myocardial recovery, Little Canada, Minn.-based St. Jude said. The device is the 1st centrifugal-flow LVAD to use fully magnetically levitated rotor technology, which the company said is designed to reduce the trauma to blood cells as they pass through the pump. This is thought to help lower the risk of blood clots. Read more
1. Sientra halts U.S. sales
Breast implant maker Sientra put a temporary hold on U.S. sales of implants made by Brazilian contract manufacturer Silimed, sending its shares down 11% in after-hours trading.
Brazilian regulator Anvisa and the U.K.’s Medicines & Healthcare Products Regulatory Agency had already suspended sales of implants made by Silimed, which is Sientra’s sole supplier, after contamination was detected during an audit of the company’s manufacturing practices. SIEN shares plummeted some -53% Sept. 24 in reaction to the British regulator’s move and hit a 52-week low of $8.01 apiece on the Anvisa ban. Read more