On Saturday, Boston Scientific Corporation ( BSX ) unveiled three-year primary endpoint results from the OPTION global clinical trial of the WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device.

The WATCHMAN implant device is about the size of a quarter and shaped like a parachute. It is implanted into the heart to close off the left atrial appendage, a blind pouch of heart tissue to prevent blood clots from forming and causing a stroke.

Key findings from the study comparing the device to first-line oral anticoagulation (OAC) – including direct oral anticoagulants (DOAC) (95%) and warfarin (5%) – for stroke risk reduction in patients with non-valvular atrial fibrillation following a cardiac ablation were presented at the American Heart Association’s Scientific Sessions 2024 and simultaneously published in “The New England Journal of Medicine.”

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The trial met the primary safety endpoint of non-procedural major bleeding or clinically relevant non-major bleeding at 36 months, with the WATCHMAN FLX device demonstrating superiority to OAC (8.5% vs.18.1%)

It also met the primary efficacy endpoint of all-cause death, stroke, or systemic embolism at 36 months, with the data showing non-inferiority of the device to OAC (5.4% vs. 5.8%).

Additional findings included non-inferiority of the WATCHMAN FLX device for the combined secondary endpoint of procedural and non-procedural major bleeding at 36 months (3.9% vs. 5.0%).

The OPTION trial included 1,600 patients.

In the trial, approximately 60% of device patients had their WATCHMAN FLX implant 90-180 days following their ablation procedure. The other nearly 40% of the device patients had the two procedures performed concomitantly, with the WATCHMAN FLX implant taking place after the ablation.

In addition to the OPTION trial, the WATCHMAN technology is being evaluated against DOAC as first-line therapy in lower-risk patients within the CHAMPION-AF randomized trial.

The latest-generation WATCHMAN FLX Pro LAAC Device was approved in the U.S. in 2023. It is similarly being studied in several clinical trials.

Price Action: BSX stock is up 4.36% at $90.79 at last check Monday.

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