FDA announcements and press releases

OPTION Trial: WATCHMAN FLX™ Device Reduces Bleeding Risk Over 36 Months in Atrial Fibrillation Patients, AHA 2024 Reports

Nov 16, 2024, 07:58 PM

Recent findings presented at the American Heart Association's 2024 conference indicate that left atrial appendage closure, specifically using the Boston Scientific WATCHMAN FLX™ device, may offer significant advantages over traditional oral anticoagulation therapy for patients with atrial fibrillation. The OPTION trial results reveal that following atrial fibrillation ablation, patients who underwent left atrial appendage closure experienced a lower risk of major bleeding events compared to those on blood thinners. Additionally, the outcomes regarding stroke, embolism, and mortality were found to be noninferior to those receiving oral anticoagulation at the 36-month mark. These findings are supported by other studies, including a randomized trial comparing the WATCHMAN device to anticoagulants, which also showed a reduction in major bleeding without an increase in adverse events. The implications of these results could influence treatment strategies for managing atrial fibrillation, particularly in patients at risk for stroke and bleeding complications.