Boston Scientific has received expanded FDA approval for its Watchman FLX and Watchman FLX Pro left atrial appendage closure (LAAC) devices. The updated premarket approval (PMA) now includes use in patients following catheter ablation for non-valvular atrial fibrillation (AFib) and introduces a newly approved post-implant drug regimen in the labeling.
Previously, both Watchman devices were indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular AFib who require an alternative to oral anticoagulants. The FLX and FLX Pro devices feature a next-generation design with polymer coating, enhanced visualization markers, and a broader size range to accommodate a wider spectrum of patients.
This label expansion follows the positive outcomes from the OPTION trial, which Boston Scientific had earlier indicated would likely support approval in the second half of 2025. In a January statement, CEO Mike Mahoney identified the Watchman franchise as a key future growth driver for the company.
Analysts from BTIG — Marie Thibault, Sam Eiber, and Alexandra Pang — described the FDA's decision as expected and reiterated their “Buy” rating for the stock. They emphasized the significance of the newly approved indication, which now allows for the Watchman to be used either during or after ablation, alongside the updated drug regimen.
“We are encouraged by this formal label expansion to include post-ablation patients. It validates the combined value of LAAC and pulsed field ablation (PFA) procedures using Watchman,” the analysts noted, adding that their estimates remain unchanged.