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.
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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
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 also the 1st aortic branch device to participate in a pivotal study. Read more
Injeq, a resident at GE’s Health Innovation Village in Helsinki, created a smart needle that tells the user about surrounding tissue for safer liver biopsies and lumbar punctures.
The Finnish company’s device looks like a standard hypodermic needle, but with an electrode attached to the tip. The needle measures changes in signal caused by contact with surrounding tissue. While a doctor is performing a lumbar puncture, the device will tell the doctor what type of tissue the needle is near and when they approach cerebrospinal fluid. Read more
Johnson & Johnson said today that it inked a deal to pick up Abbott‘s medical optics business for $4.3 billion in cash.
The deal for Abbott’s subsidiary Abbott Medical Optics, which reported sales of $1.1 billion, includes its portfolio of ophthalmic products covering cataract surgery, laser refractive surgery and consumer eye health. Read more
Boston Scientific said today that it won CE Mark approval in the European Union for its Lotus Edge, the next generation of its transcatheter aortic valve replacement.
Marlborough, Mass.-based Boston Scientific said it plans to make the Lotus Edge valve available to “select centers” in Europe, accelerating the growth of its commercial footprint “as physicians and centers become fully trained.” The original Lotus TAVR won a CE Mark back in October 2013. Read more