Healthcare company Abbott (NYSE: ABT) reported on Monday that it has achieved positive one-year results from the pivotal VERITAS study of its investigational Amulet 360 Left Atrial Appendage (LAA) Occluder, demonstrating high closure rates and a low incidence of stroke in patients with non-valvular atrial fibrillation. The findings were presented at the Transcatheter Cardiovascular Therapeutics conference in San Diego on 1 November 2026 and published simultaneously in JACC: Cardiovascular Interventions.
Complete LAA closure, defined as zero millimetres of leak, was achieved in 96.3% of patients assessed by transoesophageal echocardiography. More than 98% remained free from ischaemic stroke or systemic embolism, while more than 99% avoided pericardial effusion requiring intervention. More than 98% were free from cardiovascular-related mortality, and 93.4% experienced no major bleeding during the first year.
Amulet 360 features a softer, more conformable implant body designed to accommodate a wider range of LAA anatomies, alongside an outer disc providing a second sealing layer. The device is intended to reduce stroke risk by closing the appendage, where blood clots can form in patients with atrial fibrillation, offering an alternative to long-term anticoagulant medication for appropriate patients.
The VERITAS study enrolled more than 450 patients across over 30 hospitals in the US, Canada and Europe. Amulet 360 received CE Mark approval in August 2026. It remains investigational in the US.
SciBase technology selected as primary endpoint in NIH-led skin exposure study
FDA approves Vantis Vascular's 6F CrossFAST model
TWINBIRD launches portable freezer targeting dry-ice-free research cold chains
Urolution Medical secures FDA clearance for OpenFlo urinary catheter
Natera secures FDA Breakthrough Device designation for multi-cancer early detection assay
Okami Medical receives FDA approval for expanded indication of LOBO Vascular Occluder
Oxurion in talks to acquire Eclevar's MedTech CRO business and assets
FDA Advisory Committee votes in favour of GRAIL's Galleri multi-cancer early detection test
ProBio and Kun Tuo collaborate to deliver integrated CDMO-CRO solutions for advanced therapies
Myosin Therapeutics chosen for 2026-2027 NCI Investor Initiatives Showcase
Medtronic receives FDA clearance for LigaSure RAS Maryland instrument on Hugo system
Aptar and Aceso Therapeutics partner to advance inhaled cystic fibrosis therapy