Watchman FLX Left Atrial Appendage Closure (LAAC) Device receives CE mark approval in the EU for stroke prevention- Boston Scientific

Boston Scientific announced that the first implants of the Watchman FLX Left Atrial Appendage Closure (LAAC) Device, for stroke prevention � the latest generation of the Watchman Device � occurred in Europe following CE mark approval. 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 device is not available for sale in the U.S.

Comment: 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.