Abbott’s Amulet 360 occluder, designed to reduce stroke risk in atrial fibrillation (AFib) patients, has demonstrated strong left atrial appendage (LAA) closure rates in a new pivotal trial readout.
The one-year data from Abbott’s VERITAS (NCT06707688) pivotal study reflected complete closure of the LAA with the Amulet 360 occluder in 96.3% of patients with AFib not caused by a heart valve issue, with over 98% of patients remaining free from ischemic stroke or complications arising from blood clots through one year.
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Research indicates that for AFib patients without valve disease, most blood clots implicated in stroke begin in the LAA. Closure of the LAA, therefore, is viewed as a durable option to reduce stroke risk in AFib patients who are unsuitable for long-term blood-thinning medication regimens.
Presented during a late-breaking session at the 2026 Transcatheter Cardiovascular Therapeutics (TCT) conference, taking place 31 October to 3 November in California, and simultaneously published in JACC: Cardiovascular Interventions, Abbott’s data also showed that over 99% of patients were free from pericardial effusion, with 98% of patients free from cardiovascular-related mortality at one year.
Amulet 360 is designed to close off the LAA using a dual-seal mechanism made of two connected nitinol metal mesh components.
Christopher Piorkowski, CMO for Abbott’s electrophysiology business, commented: “Amulet 360 was designed with enhanced conformability and sealing features intended to support durable closure across a wider range of anatomies. The one-year VERITAS results reinforce the potential of these next-generation enhancements to expand patient choice and help physicians confidently offer left atrial appendage closure to patients at the right time in their care journey.”
Abbott’s next-generation Amulet 360 supersedes the company’s Amplatzer occluder. The Amulet implant, which secured a CE mark in Europe in August 2026 and is currently pending US Food and Drug Administration (FDA) clearance, is designed to be softer and more conformable than Amplatzer, to support LAA closure in a broader range of LAA shapes.
DJ Lakkireddy, executive medical director of the Kansas City Heart Rhythm Institute and lead author on the JACC publication, said: “The VERITAS trial results are highly encouraging, demonstrating high rates of complete closure sustained through 12 months. These findings reinforce the potential of the Amulet 360 technology to provide physicians with an effective treatment option as we continue to advance strategies for stroke risk reduction in this patient population.”
GlobalData analysis indicates that the global LAA closure device market is growing at a compound annual growth rate (CAGR) of 8.5% and is on course to reach a valuation of almost $6bn in 2035, more than doubling its value in 2025. Boston Scientific holds a dominant market position with its Watchman device, a nitinol implant that expands to seal off the LAA. According to a GlobalData model, Boston occupied 80% of the US LAA closure device market in 2025, followed by Abbott and AtriCure at 11.7% and 4.1%, respectively.
