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  • Editorial: Left Atrial Appendage Closure: Where Do We Stand Now?

    In March 2015 the FDA approved the WATCHMAN™ device (Boston Scientific, St. Paul, MN, USA) as an alternative to long term oral anticoagulant therapy to reduce stroke risk in patients with nonvalvular atrial fibrillation as an alternative to patients who cannot take long term oral anticoagulants. The WATCHMAN was designed more than a decade prior to approval and we now have two additional FDA approved devices for stroke prevention; the WATCHMAN FLX™ (Boston Scientific, St. Paul, MN, USA) and the AMULET™ (Abbott, Chicago, IL, USA) devices. The approval of the WATCHMAN™ device was primarily based on one moderate sized randomized clinical trial comparing warfarin to the WATCHMAN™. Subsequent multiple additional registries and further analyses of long term safety and efficacy have since been completed  . The AMULETs™ approval was based on a direct comparison between the AMULET™ and the WATCHMAN™  .

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