Boston Scientific’s Watchman FLX Approved for Expanded Labeling for Postprocedural DAPT

September 6, 2022—Boston Scientific Corporation announced it has received FDA approval to expand the instructions-for-use labeling for the current-generation Watchman FLX left atrial appendage closure device to include a 45-day dual antiplatelet therapy (DAPT) option as an alternative to the 45-day oral anticoagulation (OAC) plus aspirin for postprocedural treatment of patients with nonvalvular atrial fibrillation (NVAF)

According to the company, clinical evidence submitted to the FDA to support the labeling update included analyses spanning approximately 8,300 patients from the Left Atrial Appendage Occlusion Registry within the American College of Cardiology Foundation’s National Cardiovascular Data Registry. The data were submitted to the FDA to support the safety and efficacy of DAPT as a postprocedural antithrombotic regimen in patients with NVAF who may have a reason for seeking an alternative to OAC.

The labeling in Europe has included the choice of either OAC or a DAPT postprocedural drug regimen for Watchman technology since 2017, advised the company.

In the company’s press release, Ian Meredith, MBBS, global chief medical officer, Boston Scientific, commented, “This revised labeling provides physicians more flexibility to exercise their clinical judgment based on individual patient characteristics to determine the most appropriate post-procedural antithrombotic medication regimen. This significant step forward is supported by the robust safety and efficacy profile demonstrated by both the legacy Watchman and current-generation Watchman FLX technologies.”