BSX Stock Gains From Positive OPTION Trial Data for WATCHMAN FLX

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Boston Scientific Corporation BSX recently announced favorable three-year primary endpoint data from the OPTION global clinical trial for its WATCHMAN FLX Left Atrial Appendage Closure (“LAAC”) device. The trial data provided clinical evidence indicating that LAAC with the WATCHMAN FLX device is safe and superior to oral anticoagulation (OAC) therapy for reducing the risk of long-term bleeding events in patients who have undergone an ablation.

The OPTION trial data were presented at the American Heart Association's Scientific Sessions 2024 and published in the New England Journal of Medicine.

BSX’s Likely Stock Trend Following the News

Following the announcement, shares of BSX moved north 4% to $90.45 yesterday. The company’s structural heart programs are building momentum, banking on the strong performance of the WATCHMAN LAAC device. The next-generation WATCHMAN FLX and FLX Pro are strongly capturing the global market. In the third quarter of 2024, WATCHMAN’s organic sales grew 18% year over year. Accordingly, we expect market sentiment to remain positive surrounding the announcement.

BSX currently has a market capitalization of $128.1 billion. It has an earnings yield of 17.1%, much higher than the industry’s 12.6%.

More on WATCHMAN FLX’s Favorable Trial Data

The trial met the primary safety endpoint of non-procedural major bleeding or clinically relevant non-major bleeding at 36 months. In line with this, the WATCHMAN FLX device was found to be superior to OAC. Notably, trial data showed high rates of procedural success in patients who had a WATCHMAN FLX implant after an ablation, which reinforced positive outcomes such as low rates of ischemic and hemorrhagic stroke within the trial population. These positive primary outcomes indicate that patients receiving the WATCHMAN FLX device can eliminate long-term medication use while maintaining stroke protection.

With this positive data, the company aims to expand the indication for the WATCHMAN FLX platform.

About OPTION Trial

The randomized, controlled OPTION trial included 1,600 patients enrolled across 114 sites in the United States, Europe and Australia. In the trial, approximately 60% of device patients had their WATCHMAN FLX implant 90-180 days following their ablation procedure. Nearly 40% of the other device patients had the two procedures performed concomitantly, with the WATCHMAN FLX implant taking place after the ablation.

The study compared the device with first-line OAC therapy, which included direct oral anticoagulants (DOAC) (95%) and warfarin (5%) for stroke risk reduction in patients with non-valvular atrial fibrillation following a cardiac ablation.

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