MassDevice.com +5 | The top 5 medtech stories for September 19, 2016

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. Get this in your inbox everyday by subscribing to our newsletters.   5. Edwards Lifesciences wins expanded CE Mark for Sapien 3 replacement heart valve Edwards Lifesciences said today that it won CE Mark approval in the European Union for an expanded indication for its Sapien 3 transcatheter aortic valve replacement. The expanded indication covers patients at intermediate risk for open heart surgery, Irvine, Calif.-based Edwards said. Last month the FDA also expanded the Sapien 3 indication to include intermediate-risk aortic stenosis patients. The device won its original CE Mark approval back in January 2014, with the U.S. federal safety watchdog following suit in June 2015. Read more 4. Gore launches trial for Tag thoracic branch endoprosthesis W.L. Gore & Assoc. said today that it enrolled the 1st patient in a pivotal study evaluating its Tag thoracic branch endoprosthesis as a treatment for lesions of the aortic branch and descending thoracic aorta. The Tag TBE is the 1st Gore device to win the FDA’s expedited access pathway designation and among the 1st medical devices in the U.S. to do so, the Phoenix-based company reported. It’s...
Source: Mass Device - Category: Medical Equipment Authors: Tags: News Well Plus 5 Source Type: news