Abbott Wins CE Mark for Amulet 360 LAA Occluder

Abbott's Amulet 360™ Left Atrial Appendage Occluder has cleared CE Mark, clearing the path for commercial deployment across European markets for patients with non-valvular atrial fibrillation who cannot sustain long-term anticoagulation therapy. First implantations were completed immediately post-approval at centres in Frankfurt, Lubeck, and Aarhus, signalling an accelerated clinical rollout rather than a phased market introduction.

For device manufacturers and hospital procurement teams, the approval introduces a second-generation LAA closure platform with documented anatomical versatility. The redesigned lobe component uses a softer, more conformable construction with reduced anchor dimensions relative to Abbott's first-generation occluder, enabling treatment across a broader range of LAA morphologies. The outer disk functions as an independent sealing layer, reinforcing the dual-seal architecture carried forward from the predecessor device.

Regulatory support for the CE Mark was drawn from the VERITAS Study, a 400-patient, multi-site trial conducted across more than 30 hospitals in the U.S., Canada, and Europe. Forty-five-day data, published in JACC: Clinical Electrophysiology and presented at the AF Symposium in Boston, reported a 99.8% successful implantation rate. Complete LAA closure, defined as zero leaks greater than 3 mm, was achieved in 93.9% of patients at the 45-day endpoint. No patient complications including stroke, systemic embolism, or unplanned surgical intervention were recorded within the first seven days post-implantation.

The clinical dataset positions Amulet 360 within the evidentiary framework regulators and hospital ethics committees increasingly require before adopting structural heart devices at scale. For QA and regulatory affairs leads tracking post-market obligations under EU MDR, the VERITAS data also establishes the baseline against which post-market clinical follow-up will be benchmarked as European implant volumes grow.

Abbott has indicated broader European country expansion will proceed in the coming weeks, with no specific market sequencing disclosed at this stage.

The 45-day VERITAS closure rate of 93.9% will serve as the primary reference point as longer-term follow-up data accumulate and inform post-market surveillance submissions across EU member states.

Source: Abbott MediaRoom via PRNewswire, 27 August 2026.