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Watchman LAA Occluder Bounces Back as Alternative to OAC in CHAMPION-AF

The WATCHMAN FLX device reduced major bleeding by 45% versus oral anticoagulants in 3,000 atrial fibrillation patients, meeting all safety and efficacy endpoints in a global trial.

  • On Saturday, March 28, 2026, Boston Scientific Corporation announced that the CHAMPION-AF clinical trial met all primary and secondary endpoints, evaluating the WATCHMAN FLX device as a first-line stroke risk reduction option for patients with non-valvular atrial fibrillation.
  • Atrial fibrillation affects approximately 59 million people worldwide, increasing stroke risk fivefold; more than 90% of heart-related blood clots in patients with NVAF form in the left atrial appendage, which WATCHMAN technology permanently closes in a single procedure.
  • In the randomized trial of 3,000 patients, the WATCHMAN FLX device achieved non-inferiority to NOACs for primary efficacy endpoints at 36 months, demonstrating a 45% relative reduction in non-procedural bleeding risk compared to blood thinners.
  • Saibal Kar of Los Robles Medical Center reported that device-based closure was non-inferior to anticoagulation therapy, concluding "Watchman FLX left atrial appendage closure should be considered as an alternative to NOACs in a shared decision-making process."
  • Patient follow-up in the CHAMPION-AF trial will continue through five years to assess ischemic stroke and systemic embolism rates, while clinicians await findings from the CATALYST trial comparing different left atrial appendage closure devices.
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CHAMPION-AF study of the WATCHMAN FLX™ Left Atrial Appendage Closure Device as a first-line therapy for stroke risk reduction meets all primary and secondary safety and efficacy endpoints

MARLBOROUGH, Mass. and NEW ORLEANS, March 28, 2026

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Healio broke the news in on Saturday, March 28, 2026.
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