- Late-breaking one-year VERITAS study results were presented at the Transcatheter Cardiovascular Therapeutics conference and simultaneously published in JACC: Cardiovascular Interventions; data show the device achieved high closure rates of the left atrial appendage (LAA) and a low incidence of stroke
- Abbott's Amulet 360™ LAA Occluder is a next-generation device designed to reduce the risk of stroke and other serious blood clot-related complications in people with atrial fibrillation not caused by a heart valve issue
ABBOTT PARK, Ill., Nov. 2, 2026 /PRNewswire/ -- Abbott (NYSE: ABT), the global healthcare leader, announced today one-year results for its investigational Amulet 360™ Left Atrial Appendage (LAA) Occluder from the VERITAS study, which show meaningful closure rates of the left atrial appendage and a low incidence of stroke in people with atrial fibrillation (AFib) not caused by a heart valve issue. 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."
About the VERITAS study
The VERITAS pivotal study evaluates the safety and effectiveness of the investigational Amulet 360 device in more than 450 patients (including roll-in patients) enrolled at over 30 hospitals across the United States, Canada and Europe.
The Amulet 360 LAA Occluder is approved for investigational use only in the U.S. It received CE Mark approval in August 2026.
Frequently Asked Questions:
What is Amulet 360?
The Amulet 360 device is a minimally invasive treatment option with dual-seal technology that can adapt to the unique shape of a patient's LAA to immediately close it, providing an alternative to long-term blood-thinning medication for clinically appropriate patients. The next-generation Amulet 360 is built upon Abbott's Amplatzer™ Amulet™ LAA Occluder, which has been in use in Europe since 2013 and the U.S. since 2021.
What is the left atrial appendage?
The left atrial appendage (LAA) is a small pocket (or recess) connected to the upper left chamber of the heart that, in people with AFib, can allow blood to pool and increase the likelihood of a clot forming and traveling to the brain to cause a stroke. It is the most common place in the heart for blood clots to form and can potentially lead to stroke for people with AFib.
What is atrial fibrillation?
Atrial fibrillation (AFib) is the most common sustained cardiac arrhythmia (irregular heartbeat). It occurs when the upper chambers of the heart (atria) beat out of coordination with the lower chambers (ventricles) and contract rapidly and irregularly.
How does Amulet 360 reduce stroke risk?
Delivered through a vein in the leg, Amulet 360 is designed to close the LAA, helping prevent blood clots from leaving the appendage and reducing stroke risk.
How does Amulet 360 fit into Abbott's treatments for AFib?
Amulet 360 is part of Abbott's holistic portfolio of technologies designed to diagnose and treat AFib, and ultimately, reduce the risk of stroke. Where commercially available, doctors use cardiac ablation therapies such as Abbott's TactiFlex™ Duo Ablation Catheter, Sensor Enabled™, or Volt™ PFA System, which use different types of specialized energy to safely stop the heart's erratic signals that can trigger AFib. Abbott's EnSite™ X EP System creates highly detailed three-dimensional maps of the heart to help doctors find and treat the source of an irregular heartbeat. Procedures designed to combine Abbott's LAA closure device and treat AFib simultaneously are currently being investigated in Europe.
For U.S. important safety information go to:
Volt™ PFA System
https://www.cardiovascular.abbott/us/en/ep-clinical-evidence/volt-clinical-evidence.html
TactiFlex™ Duo Ablation Catheter, Sensor Enabled™
https://www.cardiovascular.abbott/us/en/hcp/products/electrophysiology/ablation-technology/pulse-field-ablation/tactiflex-duo-system.html#isi
EnSite™ X EP System
https://www.cardiovascular.abbott/us/en/hcp/products/electrophysiology/mapping-systems/ensite-x.html
About Abbott:
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com and on LinkedIn, Facebook, Instagram, X and YouTube.
i Lakkireddy D, et al. One-Year Safety and Effectiveness of a Next-Generation Dual-Seal Left Atrial Appendage Occluder. JACC Cardiovasc Interv. 2026. doi:10.1016/j.jcin.2026.10.023.
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