Advisory Panel Endorses Boston Scientific’s Watchman Left Atrial Appendage Closure Device

FDA’s Circulatory System Devices advisory panel voted 13-1 to recommend approval of the firm’s PMA for the Watchman device as an alternative to warfarin therapy for stroke prevention in atrial fibrillation patients for whom long-term anticoagulant therapy is too risky.

FDA’s Circulatory System Devices advisory panel overwhelmingly recommended approval of Boston Scientific Corp.’s PMA for the Watchman left atrial appendage (LAA) closure device as an alternative to warfarin therapy for stroke prevention in some atrial fibrillation patients.

Watchman is intended to prevent embolism from the left atrial appendage that could cause stroke, systemic embolism, and cardiovascular death...

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