Abbott has announced one-year results for its investigational Amulet 360 left atrial appendage (LAA) occluder from the VERITAS study, which it says show meaningful closure rates of the left atrial appendage and a low incidence of stroke in patients with atrial fibrillation (AF) not caused by a heart valve issue.
The data were presented in a late-breaking session at the Transcatheter Cardiovascular Therapeutics (TCT) conference (31 October–3 November, San Diego, USA), with the findings simultaneously published in JACC: Cardiovascular Interventions.
Presented by Dhanunjaya Lakkireddy (Kansas City Heart Rhythm Institute at HCA Midwest Health, Kansas City, USA), the data showed complete closure (0mm leak) of the LAA was achieved in 96.3% of patients evaluated with transoesophageal echocardiography (TEE). The all-cause mortality rate stood at 3.9% at one year, major bleeding occurred in 6.6% of patients, ischaemic stroke or systemic embolism occurred in 1.8% of cases, and 0.9% of cases saw pericardial effusion requiring intervention. No incidences of device embolisation occurred.
“For patients with non-valvular atrial fibrillation who require an alternative to long-term oral anticoagulation, achieving durable and complete left atrial appendage closure is an important clinical goal,” said Lakkireddy. “The VERITAS trial results are highly encouraging, demonstrating high rates of complete closure sustained through 12 months. These findings reinforce the potential of the Amulet 360 technology to provide physicians with an effective treatment option as we continue to advance strategies for stroke risk reduction in this patient population.”
The VERITAS pivotal study evaluates the safety and effectiveness of the investigational Amulet 360 device in more than 450 patients (including roll-in patients) enrolled at over 30 hospitals across the USA, Canada and Europe.
The Amulet 360 LAA Occluder is approved for investigational use only in the USA. It received CE Mark approval in August 2026.
