Abbott announced positive early results from the VERITAS study, which showed clinically meaningful closure rates of its investigational Amulet 360 left atrial appendage (LAA) occluder.

Amulet 360 is a next-gen 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 published in a late-breaking session at the AF Symposium on February 6 and published in JACC: Clinical Electrophysiology.

93.3% of non-valvular AFib patients implanted with Amulet 360 achieved complete closure of the LAA by 45 days, with leaks no larger than 3 mm. The LAA is a small, structurally complex pouch attached to the upper left atrium, which is the most common place for blood clots to form and can lead to stroke for people with the condition.

Amulet 360 is a minimally invasive treatment option that can adapt to the unique shape of the patient’s LAA to immediately close it, possible removing the need for blood-thinning medication when appropriate. It’s built on Abbott’s Amplatzer Amulet LAA occluder, which has been used in the U.S. since 2021 and Europe since 2013.

The VERITAS study had 400 patients at 34 sites in the U.S., Canada, and Europe. The trial met early benchmarks for safety and effectiveness with no complications like additional surgery, strokes, or blood clots through seven days with favorable closure at 45 days.

There was a 99.8% of implant success, with no heart tissue damage requiring surgery, brain bleeding, or device dislodgement reported in the follow-up period. There was only one device-related thrombus event, and a 0.5% reported rate of blood buildup around the heart that needed pericardial effusion.

Follow-up for the VERITAS study is expected to finish 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 Christopher Piorkowski, MD, 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.”

Last month, the company earned CE mark clearance for its TactiFlex Duo Catheter, Sensor Enabled to treat patients with AFib.