ABBOTT PARK, Ill. – November 02, 2026 -- Abbott's investigational Amulet 360 left atrial appendage (LAA) occluder achieved complete closure (zero mm leak) in 96.3% of patients assessed by transesophageal echocardiography (TEE) at one year in the VERITAS pivotal study.
Abbott (NYSE: ABT) presented the data in a late-breaking session at the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Diego on Nov. 1, 2026. The results were published simultaneously in JACC: Cardiovascular Interventions. The device targets people with non-valvular atrial fibrillation (AFib) who may need an alternative to long-term blood-thinning medication.
VERITAS one-year data show stroke-free rates above 98%
More than 98% of patients remained free from ischemic stroke or systemic embolism through one year. More than 98% were free from cardiovascular-related mortality.
More than 99% were free from pericardial effusion requiring intervention. Major bleeding events were not reported in 93.4% of patients during the first year of follow-up.
DJ Lakkireddy, M.D., executive medical director of the Kansas City Heart Rhythm Institute and president-elect of the Heart Rhythm Society, presented the data. He called the results "highly encouraging," citing complete closure sustained through 12 months.
Amulet 360 adds a softer lobe and a second sealing layer
The device has two main components. Its redesigned lobe is softer and more conformable than Abbott's previous-generation implant, allowing it to adapt to a wider range of LAA anatomies. An outer disc adds a second sealing layer over the appendage.
Christopher Piorkowski, M.D., chief medical officer of Abbott's electrophysiology business, said the design is intended to support durable closure across more anatomies. He said the one-year data reinforce the potential to expand patient choice.
Study enrolled more than 450 patients across 30-plus hospitals
VERITAS evaluates the safety and effectiveness of Amulet 360 in more than 450 patients, including roll-in patients. Enrollment spans over 30 hospitals in the United States, Canada and Europe.
Amulet 360 won CE Mark in August 2026 but remains investigational in the U.S.
The device is approved for investigational use only in the U.S. and received CE Mark approval in August 2026. It builds on Abbott's Amplatzer Amulet LAA Occluder, in use in Europe since 2013 and in the U.S. since 2021.
Amulet 360 is delivered through a vein in the leg. Abbott positions it within an AFib portfolio that includes the TactiFlex Duo Ablation Catheter, the Volt PFA System and the EnSite X EP System. Procedures combining LAA closure with AFib treatment in a single session are being investigated in Europe.