Boston Scientific has begun a trial to compare the safety and effectiveness of the next generation of one of its flagship atrial fibrillation devices.
The 36-month trial includes 1,600 enrolled patients at 130 global sites with non-valvular atrial fibrillation who will receive the Marlborough medical device company’s Watchman FLX left atrial appendage device or oral anticoagulant drugs to reduce the risk of stroke related to atrial fibrillation, which is a type of irregular heartbeat.
The trial will evaluate whether the device can replace commonly used drugs for long-term stroke risk reduction in patients with atrial fibrillation.
The Watchman device has already been implanted in more than 80,000 patients around the globe, and the FLX is already being sold in Europe after the company won CE Mark approvals in March.
The device has not yet received U.S. market clearance.
