Boston Scientific has secured expanded FDA approval for its Watchman FLX and FLX Pro left atrial appendage closure (LAAC) devices. The update includes use in patients undergoing catheter ablation for non-valvular atrial fibrillation and adds a new post-implant drug regimen to the labeling.
The Watchman devices are designed to reduce stroke risk in AFib patients who need alternatives to oral anticoagulants. The latest FLX versions feature enhanced visualization markers, a broader size range, and a polymer coating to support a wider patient population.
This expansion aligns with positive findings from the OPTION trial and expectations Boston Scientific set for H2 2025. Analysts at BTIG say the approval confirms the value of combining LAAC with pulsed field ablation, reinforcing Watchman’s role as a key growth driver.
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