National Medicare Analysis Opened For Watchman Device

CMS opened a formal review to consider a national Medicare coverage policy for Boston Scientific's Watchman left atrial appendage closure device to prevent stroke May 21.

Watchman was approved by FDA in March after three advisory panels and two pivotal trials. The approved labeling for reducing the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism is enough to secure a $500 million market, analysts say, presuming reimbursement is sufficient