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The release is datelined "ABBOTT PARK, Ill., Aug. 27, 2026" and says Abbott "announced today it has received CE Mark for the Amulet 360 Left Atrial Appendage (LAA) Occluder".[1]- Start
- Aug 27, 202690% CONFIDENCEsource
Abbott's Amulet 360 LAA Occluder Wins CE Mark
Abbott's next-generation Amulet 360 left atrial appendage occluder received CE Mark to cut stroke risk in non-valvular atrial fibrillation, with the first European implants done in Frankfurt, Lubeck and Aarhus.
- Abbott received CE Mark for the Amulet 360 Left Atrial Appendage Occluder to reduce stroke risk in non-valvular AFib; the first European cases were done by Prof. Boris Schmidt in Frankfurt, Prof. Ingo Eitel in Lubeck and Prof. Jens Erik Nielsen-Kudsk in Aarhus, with wider European use in the coming weeks[1]
- The device has a softer, more conformable lobe with smaller anchors than the previous generation plus an outer disk as a second seal, and builds on the Amplatzer Amulet, in use in Europe since 2013 and the U.S. since 2021[1]
- In the VERITAS study of 400 patients at 34 sites, implant success was 99.8%, the primary safety endpoint rate 0.0%, and 93.9% of patients had complete closure (0 mm leak) at 45 days[3]
- Abbott calls it the company's fourth major electrophysiology approval in just over a year; Amulet 360 remains approved for investigational use only in the U.S.[1]
- MedTech Dive reports Abbott aims to take share from Boston Scientific: CEO Robert Ford called LAA closure a $2 billion market in which the competitor has a 90% share, and Abbott completed an FDA submission for Amulet 360 in May[2]