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The purpose of the Medical Device Vigilance System is to improve the protection of health and safety of patients, healthcare professionals, and other users by reducing the likelihood of reoccurrence of incidents related to the use of a medical device.
Two RCTs have evaluated the Watchman device for stroke prevention in patients with atrial fibrillation (AF). The single RCT published is the PROTECT-AF study,(4) which was a randomized, unblinded trial that evaluated the noninferiority of an LAA closure device compared with warfarin for stroke prevention in AF.