Global Finance News
27 Aug 2026, 16:42
Abbott Wins CE Mark for Next-Generation Amulet 360 Stroke Prevention Device
Abbott (NYSE: ABT) has received CE Mark approval for its next-generation Amulet 360 Left Atrial Appendage Occluder, allowing the company to begin expanding the device across Europe.
Amulet 360 is designed for patients with non-valvular atrial fibrillation who are at risk of stroke, particularly those unable to remain on long-term blood-thinning medication. The minimally invasive device seals the left atrial appendage, where blood clots commonly form in AFib patients.
The approval was supported by the 400-patient VERITAS study. Amulet 360 was successfully implanted in 99.8% of patients, while 93.9% achieved complete closure after 45 days with no leaks larger than 3 mm. No strokes, blood clots or additional surgeries were reported during the first seven days.
The approval strengthens Abbott's cardiovascular device portfolio and marks its fourth major electrophysiology approval in just over a year. Initial European procedures have already been completed in Germany and Denmark, with a broader European rollout planned in the coming weeks.
Amulet 360 remains investigational and is not yet approved for commercial use in the U.S.
Abbott (NYSE: ABT) has received CE Mark approval for its next-generation Amulet 360 Left Atrial Appendage Occluder, allowing the company to begin expanding the device across Europe.
Amulet 360 is designed for patients with non-valvular atrial fibrillation who are at risk of stroke, particularly those unable to remain on long-term blood-thinning medication. The minimally invasive device seals the left atrial appendage, where blood clots commonly form in AFib patients.
The approval was supported by the 400-patient VERITAS study. Amulet 360 was successfully implanted in 99.8% of patients, while 93.9% achieved complete closure after 45 days with no leaks larger than 3 mm. No strokes, blood clots or additional surgeries were reported during the first seven days.
The approval strengthens Abbott's cardiovascular device portfolio and marks its fourth major electrophysiology approval in just over a year. Initial European procedures have already been completed in Germany and Denmark, with a broader European rollout planned in the coming weeks.
Amulet 360 remains investigational and is not yet approved for commercial use in the U.S.
