Boston Scientific Gets FDA Approval For Expanded Labeling Of WATCHMAN FLX LAAC Device

(RTTNews) - Medical technology company Boston Scientific Corp. (BSX) announced Tuesday that it has received U.S. Food and Drug Administration approval for expanded labeling of WATCHMAN FLX Left Atrial Appendage Closure or LAAC device for dual anti-platelet therapy as post-procedural medication option.

The instructions for use labeling will now include a 45-day dual anti-platelet therapy or DAPT option as an alternative to 45-day oral anticoagulation or OAC plus aspirin for post-procedural treatment of patients with non-valvular atrial fibrillation or NVAF.

WATCHMAN FLX is now the only LAAC technology in the United States that allows for either DAPT or OAC immediately following implantation.

The company noted that the clinical evidence submitted to the FDA to support the labeling update included analyses spanning around 8,300 patients from the Left Atrial Appendage Occlusion Registry or LAAO Registry.

The data was submitted to the FDA to support the safety and efficacy of DAPT as a post-procedural 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 post-procedural drug regimen for WATCHMAN technology since 2017.

Ongoing studies with the WATCHMAN FLX device include the CHAMPION-AF and OPTION clinical trials to evaluate use of the device for broader patient populations with NVAF.

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