
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. TAVI study: Sapien tops CoreValve in AR risk, but is CoreValve safer?
The results from a new registry study offered a mixed safety profile comparing Medtronic’s and Edwards Lifesciences’ rival 1st-generation transcatheter aortic valve implantation systems.
Patients in the study who received Medtronic’s CoreValve implant were more likely to have aortic regurgitation (AR) following surgery, but AR was associated with a “significantly worse outcome” only in Sapien patients, according to the study. Overall, mortality rates were the same across both devices. Read more
2. Mass. Supremes deny St. Jude Medical in laser spat with Volcano
The highest court in Massachusetts largely denied
St. Jude Medical’s bid to overturn the few portions of a lower court’s decision that didn’t go its way in its long-running laser technology spat with Volcano.
The Mass. Supreme Judicial Court last week ruled to uphold the court’s decision to exclude 1 of St. Jude’s expert witnesses on the grounds that his testimony was too speculative, according to court documents. The Bay State high court also declined to impose a permanent injunction against Volcano, but granted St. Jude’s move for declaratory relief, according to the documents. Read more
1. FDA panel narrowly OKs Cohera Medical’s TissuGlu
The FDA’s General & Plastic Surgery Devices Advisory Panel narrowly recommended approval for Cohera Medical’s polyurethane-based TissuGlu adhesive for the approximation of tissue layers to bind subcutaneous dead space between the tissue planes in large flap surgical procedures, including abdominoplasty.
The panel voted unanimously that TissuGlu is safe; 6-5 that it is effective; and 6-4 with 1 abstention that the adhesive’s benefits outweigh its risks. Read more