WATCHMAN FLX Device Cuts Bleeding Risks in Atrial Fibrillation Patients by 45%
WATCHMAN FLX Device Cuts Bleeding Risks in Atrial Fibrillation Patients by 45%
WATCHMAN FLX Device Cuts Bleeding Risks in Atrial Fibrillation Patients by 45%
A major clinical trial has shown that the WATCHMAN FLX device significantly reduces bleeding risks in patients with atrial fibrillation. The study compared the implant to standard blood-thinning drugs, revealing strong benefits for those at high stroke risk. Results were announced on 28 March 2026 after testing at 141 sites worldwide. The CHAMPION-AF trial is the largest of its kind, evaluating the WATCHMAN FLX Left Atrial Appendage Closure (LAAC) device against non-vitamin K antagonist oral anticoagulants (NOACs). Over 600,000 patients have already received the WATCHMAN implant, making it the most widely used and studied LAAC device available.
The trial found the device statistically superior in cutting non-procedural major and clinically relevant non-major bleeding by 45%. It also matched NOACs in preventing stroke, cardiovascular death, and systemic embolism. Procedural success reached 99%, with no increase in major bleeding during implantation. Atrial fibrillation (AF) affects around 59 million people globally, raising stroke risk fivefold compared to those with normal heart rhythms. The WATCHMAN FLX, approved in the U.S. in 2023, is now being tested in further trials. Boston Scientific Corporation confirmed the study met all primary and secondary safety and efficacy goals.
The findings suggest the WATCHMAN FLX device offers a safer alternative to long-term blood thinners for stroke prevention. Its approval in the U.S. and ongoing studies may expand its use worldwide. The trial's results could influence treatment guidelines for millions with atrial fibrillation.
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