A new device is showing promising results in reducing stroke risk for individuals with atrial fibrillation. Abbott recently shared early data from the VERITAS study, evaluating its investigational Amulet 360 left atrial appendage (LAA) occluder.
Closing the Gap on Stroke Prevention
The data, presented at the AF Symposium in Boston on February 6, 2026, and published in JACC: Clinical Electrophysiology, demonstrate clinically meaningful closure rates with the occluder.
- 93.9% of patients achieved full LAA closure by 45 days.
- No leaks greater than 3mm were observed.
- The implant success rate was exceptionally high, at 99.8%.
- No device dislodgement or heart tissue injury requiring surgery occurred.
For patients with non-valvular atrial fibrillation (AFib), a small pouch in the heart called the left atrial appendage (LAA) can significantly increase stroke risk. The Amulet 360 is designed to close off this pouch, potentially eliminating the need for long-term blood-thinning medication – a major benefit for many.
Minimally Invasive and Adaptable
This device builds upon Abbott’s existing Amplatzer Amulet LAA Occluder, which has been available in Europe since 2013 and in the United States since 2021. The Amulet 360 features updates intended to optimize how the implant conforms to each patient’s unique LAA shape, allowing for immediate closure.
The VERITAS study involved 400 patients across 34 sites in Europe, Canada, and the US. Researchers found that the device met both effectiveness and safety benchmarks. Importantly, no complications such as stroke, surgery, or clot formation were reported within seven days of the procedure.
What are the benefits of closing the LAA? By sealing off the LAA, doctors can reduce the risk of stroke in patients with AFib, potentially allowing them to discontinue blood-thinning medications.
Beyond the high closure rate, the study also revealed a 99.8% implant success rate. Only one case of device-related thrombus was reported, and pericardial effusion requiring drainage occurred in just 0.5% of cases. No instances of device dislodgement or heart tissue injury necessitating surgery were observed.
Christopher Piorkowski, chief medical officer of Abbott’s electrophysiology business, stated: “Abbott is committed to developing minimally invasive approaches that help doctors address AFib and prevent strokes, ensuring optimal safety and benefits for patients. With the next-generation Amulet 360, we are building upon the advancements we made with the introduction of our Amplatzer Amulet LAA occluder, which was the first device in the industry to both close the LAA and create a seal over it, allowing people to forgo blood-thinning medication.”
Follow-up for the VERITAS Study is scheduled to conclude in 2027. Currently, the Amulet 360 is approved for investigational use only in the United States.
In December 2025, the US Food and Drug Administration (FDA) granted approval for Abbott’s Volt PFA System, further expanding treatment options for patients with AFib.
