|Trade Name||WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY|
|Classification Name||system, appendage closure, left atrial|
|Applicant||BOSTON SCIENTIFIC CORP.|
|Expedited Review Granted?|| No|
||Labeling, Approval Order, Summary of Safety and Effectiveness|
|Approval Order Statement |
Approval for the watchman laa closure technology. This device is indicated to reduce the risk of thromboembolism from the left atrial appendage (laa) in patients with non-valvular atrial fibrillation who: ¿ are at increased risk for stroke and systemic embolism based on chads2 or cha2ds2-vasc scores and are recommended for anticoagulation therapy; ¿ are deemed by their physicians to be suitable for warfarin; and ¿ have an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin.