Boston Scientific Receives CE Mark For Next Generation WATCHMAN FLX™ Left Atrial Appendage Closure Device

Boston Scientific

today announced that the first implants of the WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device – the latest generation of the WATCHMAN Device – occurred in Europe following CE mark approval. "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," said Dr. Kenneth Stein, chief medical officer, Rhythm Management, Boston Scientific. "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." WATCHMAN FLX Device implants were performed last week by Dr. Horst Sievert, department head of Cardiology and Vascular Medicine, Sankt Katharinen Hospital, in Frankfurt, Germany; by Dr. Vivek Reddy, director of Cardiac Arrhythmia Services for The Mount Sinai Hospital, at Na Homolce Hospital in Prague, Czech Republic; and Dr. Saibal Kar, director of Cardiovascular Intervention Center Research at Cedars-Sinai Heart Institute, at MC Medicor in Izola, Slovenia. "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 with simple to the most complex anatomies," said Dr. Sievert. "With nearly a decade of experience implanting the original WATCHMAN Device, it has been exciting to see the advancements of this technology from Boston Scientific and take part in the first implants of this device in Europe." The first-generation WATCHMAN Device was CE-marked in 2005 to prevent thrombus embolization from the left atrial appendage (LAA) and reduce the risk of life-threatening bleeding events in patients with non-valvular atrial fibrillation (AF) who are eligible for anticoagulation therapy, and in 2012 the CE Mark indication was expanded to include those who have a contraindication to anticoagulation therapy. AF affects approximately 15 million patients worldwide and is a disorder that disrupts the ability of the heart to beat regularly and pump blood efficiently. Patients with AF have an increased risk of stroke due to the migration of clots formed in the LAA. This approval marks the second significant regulatory and commercial milestone for the Structural Heart business of Boston Scientific this year, following the U.S. Food and Drug Administration (FDA) approval of the first-generation WATCHMAN Device in March, 2015. In the U.S., the WATCHMAN Device is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are deemed by their physicians to be suitable for warfarin, and have an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin. Commercialization of the WATCHMAN FLX Device is currently in a limited market release and will become more widely available to approved EU countries in the first half of 2016. The WATCHMAN FLX Device is not available for sale in the U.S.