Abbott Announces One-Year Results For Its Amulet 360 Left Atrial Appendage Occluder From The VERITAS Study; Data Show Meaningful Closure Rates Of Left Atrial Appendage And A Low Incidence Of Stroke In People With Atrial Fibrillation Not Caused By A Heart Valve Issue
Benzinga Newsdesk 9 hours ago
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The data were presented in a late-breaking session at the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Diego, Calif., on Nov. 1, 2026, and simultaneously published in JACC: Cardiovascular
The data were presented in a late-breaking session at the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Diego, Calif., on Nov. 1, 2026, and simultaneously published in JACC: Cardiovascular Interventions.
Amulet 360 is Abbott's next-generation LAA occlusion device designed to reduce the risk of stroke in people with AFib, an irregular heartbeat in the heart's upper chambers, which is not caused by a heart valve issue (non-valvular) and who may need an alternative to long-term blood-thinning medication. It is built on Abbott's LAA occlusion technology with enhancements designed to support clinical performance and patient outcomes.
VERITAS study demonstrates strong one-year closure results
Late-breaking one-year data from the VERITAS pivotal studyi showed complete closure (zero mm leak) of the LAA was achieved in 96.3% of patients evaluated with transesophageal echocardiography (TEE), a heart ultrasound test used during and after an Amulet 360 LAA procedure.
Other long-term findings from the VERITAS late-breaker include:i
More than 98% of patients remained free from ischemic stroke (the most common type of stroke) or systemic embolism (complications from a blood clot) through one year.
More than 99% of patients were free from pericardial effusion (a buildup of fluid around the heart) that required intervention.
More than 98% of patients were free from cardiovascular-related mortality.
Major bleeding events were not reported in 93.4% of patients during the first year of follow-up.
"For patients with non-valvular atrial fibrillation who require an alternative to long-term oral anticoagulation, achieving durable and complete left atrial appendage closure is an important clinical goal," said DJ Lakkireddy, M.D., executive medical director of the Kansas City Heart Rhythm Institute, professor of medicine at the University of Missouri and president-elect of the Heart Rhythm Society, who presented the late-breaking VERITAS data at the Transcatheter Cardiovascular Therapeutics conference. "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."
Updated design features support improved LAA closure
Amulet 360 incorporates new design enhancements and features two main components:
The implant's redesigned body, or lobe, is softer and more conformable than Abbott's previous-generation device. This design allows the implant to adapt to a wider range of LAA anatomies.
An outer disc provides a second sealing layer to help close off the LAA.
"Physicians treating patients with non-valvular atrial fibrillation need solutions that can perform consistently across the broad range of left atrial appendage anatomies they encounter in practice," said Christopher Piorkowski, M.D., chief medical officer of Abbott's electrophysiology business. "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."