Boston Scientific wins CE Mark for next-gen Watchman FLX

Boston Scientific (NYSE:BSX) said today it won CE Mark approval in the European Union for its Watchman FLX left atrial appendage closure device, and announced the device has been successfully implanted in its 1st set of patients. The 1st Watchamn FLX devices were implanted last week by Dr. Horst Sievert of Frankfurt, Germany’s Sankt Katharinen Hospital, Dr. Vivek Reddy of Mt. Sinai Hospital in Prague’s Na Homolce Hospital and by Dr. Saibal Kar of Cedars-Sinai Heart Institute at Izola, Slovenia’s MC Medicor, Marlborough, Mass.-based Boston Scientific said. “The Watchman Device is the most studied left atrial appendage closure device and has been used to help reduce the risk of stroke for tens of thousands of high-risk patients with non-valvular atrial fibrillation who seek an alternative to long-term anticoagulant therapy. We are pleased that this next-generation technology has been granted European regulatory approval and we can begin a controlled product roll-out to clinicians throughout Europe,” rhythm management chief medical officer Dr. Kenneth Stein said in a press release. The Watchman FLX is currently only commercialized in a limited market, Boston Scientific said, and will be expanded to wider availability to approved EU countries in the 1st half of 2016. “The closed-end design of the Watchman FLX Device and the ability to fully recapture and reposition this device make it a very promising option for treating indicated patients ...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiac Implants Cardiovascular Regulatory/Compliance Boston Scientific Source Type: news