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Boston Sci’s Watchman Stroke Device Finally Lands FDA Approval, With Favorable Labeling

Three separate FDA advisory panels examined the clinical data supporting the left-atrial appendage closure device and struggled to identify exactly which patients it benefits. But FDA has finally approved Watchman with an indication that analysts say will support meaningful market action for Boston Scientific. Reimbursement policies, however, remain a question mark.

After over a decade of development, two major clinical trials and three FDA advisory panels, Boston Scientific Corp.’s Watchman is finally set to reach the U.S. market. FDA approved the PMA for the left-atrial appendage closure device to prevent stroke in some patients with atrial fibrillation on March 13.

FDA and its advisors reviewing the device's data over the years struggled to identify exactly which patients it benefits. But the agency ultimately approved Watchman for reducing the risk of...

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