Abbott announced positive early results from the VERITAS study that show clinically meaningful closure rates of the investigational Amulet 360 Left Atrial Appendage (LAA) Occluder, a next-generation implant designed to reduce risk of stroke in patients with Atrial Fibrillation (AFib) not caused by a heart valve issue (non-valvular). The results were presented in a late-breaking session at the AF Symposium in Boston on 6 February, 2026, and simultaneously published in JACC: Clinical Electrophysiology.
Results from the VERITAS study show 93.9 percent of non-valvular AFib patients implanted with the Amulet 360 achieved complete closure of the LAA by 45 days, with no leaks greater than 3 mm. The LAA is a small, structurally complex pouch attached to the upper left chamber (atrium) of the heart, which is the most common place for blood clots to form and can potentially lead to stroke for people with this condition. The Amulet 360 device is a minimally invasive treatment option that can adapt to the unique shape of a patient’s LAA to immediately close it, potentially eliminating the need for blood-thinning medication when clinically appropriate. The next-generation Amulet 360 is built upon Abbott’s Amplatzer Amulet LAA Occluder, which has been in use in the US since 2021 and in Europe since 2013. Amulet 360 includes design updates intended to enhance how the implant conforms to a patient’s heart.
The VERITAS study included 400 patients at 34 sites across the US, Canada and Europe. Key findings confirm the trial met its early benchmarks for safety and effectiveness with no complications such as additional surgery, strokes, or blood clots through seven days with a favourable closure rate at 45 days. Results also show:
(i) there was a high rate (99.8%) of implant success.
(ii) favourable early outcomes in patients – no heart tissue damage requiring surgery, brain bleeding or device dislodgement reported within the follow-up period.
(iii) positive safety profile with only one Device-Related Thrombus (DRT) event, and a low reported rate (0.5%) of blood build-up around the heart that needed to be drained (pericardial effusion).
(iv) follow-up from all patients indicated a clinically meaningful LAA closure at 45 days with no leaks greater than 3 mm.
"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," said Christopher Piorkowski, MD, Chief Medical Officer—Ectrophysiology Business, Abbott.
Follow up for the VERITAS Study is anticipated to conclude in 2027.
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