Abbott (NYSE:ABT) today announced positive early results from a study evaluating its investigational Amulet 360 left atrial appendage (LAA) occluder.
Amulet 360, a next-generation implant, was designed to reduce the risk of stroke in patients with AFib not caused by a heart valve issue (non-valvular).
Currently, the market has plenty of devices targeting the LAA, including Abbott’s own Amplatzer Amulet. That includes Boston Scientific’s Watchman system, Medtronic’s Penditure, AtriCure’s AtriClip and the Conformal Medical (soon to be part of Gore) CLAAS device. Watchman received expanded FDA labeling for this treatment type last year.
Amulet 360, a minimally invasive treatment option, can adapt to the unique shape of the lAA to immediately close it. This could potentially eliminate the need for blood-thinning medication when clinically appropriate. Abbott built it upon the Amplatzer Amulet system, which entered the U.S. market in 2021, having been available in Europe since 2013.
The next-generation Amulet 360 includes design updates intended to enhance how the implant conforms to a patient’s heart.
Abbott now hopes to bring its investigational device to the LAA occlusion space, with results from the VERITAS study presented at the AF Symposium in Boston today and simultaneously published in JACC: Clinical Electrophysiology.
The findings for the Abbott Amulet 360 LAA occluder
Abbott said that 45-day data from VERITAS showed that 93.9% of non-valvular AFib patients who received Amulet 360 achieved complete closure of the LAA within that 45-day period. Patients experienced no leaks greater than 3 mm.
VERITAS evaluated 400 patients across 34 sites in the U.S., Canada and Europe, Findings included the meeting of early benchmarks for safety and effectiveness, with no complications like additional surgery, strokes or blood clots through seven days, plus the favorable closure rate at 45 days.
Investigators also reported a high rate (99.8%) of implant success and favorable early outcomes. Patients experienced no heart tissue damage requiring surgery, brain bleeding or device dislodgement within the follow-up period.
Abbott reports a positive safety profile, with one device-related thrombus event. Amulet 360 also delivered a low reported rate (0.5%) of blood build-up around the heart that needed draining (pericardial effusion). Follow-up indicated clinically meaningful LAA closure at 45 days in all patients.
The company expects to complete follow-up for VERITAS in 2027.
“Abbott is committed to developing minimally invasive approaches that help doctors address AFib and prevent strokes, ensuring optimal safety and benefits for patients,” said Dr. Christopher Piorkowski, chief medical officer of Abbott’s electrophysiology business. “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.”
