Abbott has announced CE marking for the Amulet 360 left atrial appendage (LAA) occluder for reducing risk of stroke in patients with non-valvular atrial fibrillation (AF).
Following approval, the first European cases using Amulet 360 were completed Boris Schmidt at the Cardiovascular Clinic Bethanien (Frankfurt, Germany), Ingo Eitel at the University Heart Center Lubeck (Lubeck, Germany), and Jens Erik Nielsen-Kudsk at Aarhus University Hospital (Aarhus, Denmark). The company will further expand the use of Amulet 360 across European countries in the coming weeks.
Amulet 360 is made of two primary components. The device’s redesigned body, called a lobe, which the company says is softer and more conformable than Abbott’s previous-generation LAA occluder to help treat more people with different types of LAA shapes. Amulet 360’s lobe has smaller anchors than the previous version to secure it in the LAA. The implant’s outer disk is a second sealing layer to help close off the LAA.
“With Amulet 360, doctors can help protect more people with AF from stroke by confidently closing the left atrial appendage,” said Xavier Freixa (Hospital Clínic de Barcelona, Barcelona, Spain). “By helping doctors treat a wider range of anatomies, this next-generation device has the potential to improve outcomes and help more people benefit from stroke prevention across Europe.”
CE mark for Amulet 360 was supported by insights from the VERITAS study, which included 400 patients at more than 30 hospitals across the USA, Canada and Europe. The study’s 45-day results showed clinically meaningful closure rates and device, the company states.
“Amulet 360 builds on the proven legacy of our unique dual-seal design seen in the first-generation LAA occluder, which helped many people with AF reduce their risk of stroke without the need for long-term blood thinners,” said Christopher Piorkowski, chief medical officer of Abbott’s electrophysiology business. “As the latest addition to Abbott’s growing portfolio of stroke prevention technologies, Amulet 360 reflects our commitment to advancing treatment options and improving outcomes for patients around the world.”
