Percutaneous Left Atrial Appendage Closure Device for Stroke Prevention
Defines medical necessity criteria and coverage stance for FDA‑approved percutaneous LAA occlusion devices (WATCHMAN, WATCHMAN FLX, Amplatzer Amulet) to reduce stroke risk in adults with non‑valvular atrial fibrillation, and states noncoverage for other percutaneous devices lacking sufficient evidence.
Updated criteria I and II to include all FDA approved percutaneous devices for occlusion of the LAA (WATCHMAN, WATCHMAN FLX, Amplatzer Amulet) and removed verbiage that the WATCHMAN is the only FDA approved device.
Changed criteria wording from 'both' to 'all' of the following in criteria I and removed previously listed specific contraindications, adding criterion I.C 'Ability to tolerate short-term anticoagulants'.
II clarified to state there is a paucity of evidence regarding long-term safety and efficacy of percutaneous devices other than the FDA‑approved devices; such devices are not supported.
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