Abbott has reported positive early data from the VERITAS study, evaluating its investigational Amulet 360 left atrial appendage (LAA) occluder, designed to reduce stroke risk in patients with non-valvular atrial fibrillation (AFib).
Presented at the AF Symposium in Boston on 6 February 2026 and published in JACC: Clinical Electrophysiology, the data show that the occluder achieved clinically meaningful closure rates.
According to VERITAS Study data, 93.9% of non-valvular AFib patients implanted with the Amulet 360 achieved full closure of the LAA by 45 days, with no leaks over 3mm. The LAA is a small pouch linked to increased stroke risk in AFib patients.
The device is minimally invasive and adapts to each patient’s unique LAA shape, providing immediate closure and potentially reducing the need for blood-thinning medication where suitable.
It builds on Abbott’s existing Amplatzer Amulet LAA Occluder, available in Europe since 2013 and the US since 2021. The latest device introduces updates intended to optimise how the implant conforms within the heart.
VERITAS involved 400 patients at 34 sites across Europe, Canada, and the US. Key findings confirm that effectiveness and safety benchmarks were met, and no complications such as stroke, surgery, or clot formation occurred within seven days post-procedure.
Additional results include a high implant success rate of 99.8%. No reported device dislodgement or heart tissue injury needing surgery, and only one case of device-related thrombus was reported. Pericardial effusion requiring drainage was observed in just 0.5% of cases.
Abbott electrophysiology business chief medical officer Christopher Piorkowski said: “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 will conclude in 2027. In the US, Amulet 360 is approved for investigational use only.
In December 2025, the US Food and Drug Administration (FDA) granted approval for Abbott’s Volt PFA System, expanding treatment options for patients with AFib.
