CMS Will Now Cover Watchman LAA Closure Device

February 12, 2016

MARLBOROUGH, MA — The percutaneously delivered Watchman left atrial appendage (LAA) closure device (Boston Scientific), approved 11 months ago in the US for stroke prevention in some patients with atrial fibrillation (AF), will now be covered for Medicare beneficiaries, the company has announced[1].

The Centers for Medicare and Medicaid Services (CMS) is allowing coverage according to specific criteria set out in its February 8, 2016 coverage decision memo[2]. The requirements include following patients for outcomes in an approved registry; also, patients should be "suitable for short-term warfarin but deemed unable to take long-term oral anticoagulation."

The Watchman was approved by the US Food and Drug Administration in March 2015 for patients with nonvalvular AF at high risk of stroke. Its road to approval was a long one; it was considered by an FDA advisory committee three separate times before receiving a positive recommendation by a thin margin.

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