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US Device Guide / Left Atrial Appendage Closure

Company Name Product Name Delivery System Name Available Device Sizes (mm) Delivery Access Delivery System OD (F) Access System OD (F) Access System Sheath Length (cm) Available Access System Configurations Device Frame Material Membrane Material US FDA Indicated Use
Boston Scientific Corporation Watchman Left Atrial Appendage Closure Device Watchman Access System 21, 24, 27, 30, 33 Femoral venous access and interatrial septum crossing into the left atrium 12 14 75 Single curve, double curve, anterior curve Nitinol alloy Polyethylene terephthalate knit fabric, 160-┬Ám mesh Indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with nonvalvular atrial fibrillation who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2 DS2 -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 nonpharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin

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