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  • Post-Approval Safety Profile of Amulet vs Watchman FLX Left Atrial Appendage Closure Devices: Analysis from the MAUDE Database (ALERT-MAUDE Study)

    Left atrial appendage closure (LAAC) has evolved as an excellent alternative therapy for patients with atrial fibrillation (AF) who are considered poor candidates for oral anticoagulation  . The second-generation Watchman FLX (Boston Scientific Inc.) has been available for commercial use in the United States since July 2020. This iteration of the Watchman underwent significant re-design of the back end of the device, eliminating the sharp “legs” which used to protrude and impact the appendage wall. More recently, the Amulet device (Abbott) which has a dual occlusive closure mechanism was approved for LAAC by the Food and Drug Administration (FDA) in August 2021. The SWISS-APERO trial demonstrated higher major periprocedural complications with Amulet compared with Watchman FLX in patients undergoing LAAC  . We sought to evaluate the incidence and types of adverse events (AEs) in LAAC procedures with the Amulet and Watchman FLX devices using the FDA Manufacturer and User Facility Device Experience (MAUDE) database. The study does not require an IRB approval.

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