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- Aug 27, 202690% CONFIDENCEfrom the source
Abbott's Amulet 360 LAA Occluder Wins CE Mark
- 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]
References 388% CONFIDENCE
The first entry is always the pin's source. Overall confidence is a weighted average of how firmly each reference supports the start and end times used above; a reference counts half as much for every 180 days older than the newest.
- [1]90%abbott.mediaroom.com/2026-08-27-Abbotts-next-generation-Amulet-360-TM-device-receives-CE-Mark-to-treat-people-with-atrial-fibrillation-at-risk-of-strokeabbott.mediaroom.com· Posted Sep 23, 2026· Starts Aug 27, 2026 ✓· 43% of score
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".
- [2]85%Abbott wins CE mark for new LAA closure devicemedtechdive.com· Published Aug 28, 2026· 39% of score
MedTech Dive's report of the CE Mark with the market context (Boston Scientific's share, Ford's $2 billion market figure) and the May FDA submission.
- [3]88%Early Outcomes With a Next-Generation Dual-Seal Left Atrial Appendage Occluder: Results From the VERITAS Study (JACC: Clinical Electrophysiology)doi.org· Published Feb 6, 2026· 18% of score
The peer-reviewed VERITAS 45-day results that the release says supported the CE Mark: 400 patients, 99.8% implant success, 93.9% complete closure.[1]
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