FDA expands LAA closure device labeling to include 45-day DAPT option
Boston Scientific announced the FDA indication for its left atrial appendage closure device has been expanded to include a 45-day dual antiplatelet therapy option after treatment of patients with nonvalvular atrial fibrillation.
The 45-day DAPT option serves as an alternative to 45-day oral anticoagulation plus aspirin, according to a company press release.
The updated labeling for the LAA closure device (Watchman FLX), which is used to prevent stroke in patients with nonvalvular AF, has been available in Europe since 2017.
"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," Ian Meredith, AM, executive vice president and global chief medical officer for Boston Scientific, said in the release. "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."
The approval is based on analyses including approximately 8,300 patients from the Left Atrial Appendage Occlusion Registry (LAAO) within the American College of Cardiology Foundation's National Cardiovascular Data Registry, according to the release.
Additionally, the device safety profile as shown by the results of the SURPASS trial further supported the FDA’s decision to update the device labeling, the company stated in the release.
As Healio previously reported, the LAA closure device was associated with low rates of adverse events and peri-device leak in a real-world cohort at 45 days: death, 0.91%; stroke, 0.38%; ischemic stroke, 0.28%; systemic embolism, 0.01%; device-related thrombus, 0.23%; device embolization, 0.03%; and major bleeding, 3.55%.
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