Boston Scientific temporarily stops sales of Watchman FLX LAAC for stroke prevention in Europe due to increase in rate of embolisms.
Boston Scientific Corp has said it has temporarily stopped selling its Watchman FLX atrial fibrillation treatment in Europe due to a higher-than-expected rate of embolisms associated with the implant. The FLX model, launched in some European markets in November, is a second-generation version of the Watchman device sold in the United States.
The implant is designed to prevent strokes in patients with a form of atrial fibrillation, or irregular heartbeat. The device works by sealing off the left atrial appendage where blood can pool and clot and allows patients to stop taking the blood thinner warfarin. The company will look at whether physician training and implant technique are causing the higher-than-expected rate of device-related embolisms. Boston Scientific medical officers told an investor meeting at the American College of Cardiology scientific sessions in Chicago.
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