Boston Scientific Buys Atritech For Watchman Stroke Prevention Device
This article was originally published in The Gray Sheet
Boston Scientific will acquire the Watchman minimally invasive stroke-prevention device for patients with atrial fibrillation through its Jan. 19 purchase of Atritech for up to $375 million.
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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.
FDA has requested that a PMA for Boston Scientific’s Watchman left atrial appendage closure device for stroke-prevention be subject to another advisory panel meeting -- the third since 2009 -- which will delay the launch to, at earliest, the first half of 2015, the company says.
Boston Scientific is highlighting a secondary-endpoint analysis showing that the left atrial appendage closure device reduced all-cause death by 34%. The company plans to submit a PMA for the device by the end of the second quarter.