Abbott reports favorable one-year results for investigational Amulet 360 device
Abbott reported on Nov. 2, 2026, that one-year VERITAS results for its investigational Amulet 360 left atrial appendage occluder were presented at the TCT conference and published in JACC: Cardiovascular Interventions. Among evaluated patients, transesophageal echocardiography showed zero-leak closure in 96.3%; more than 98% remained free of ischemic stroke or systemic embolism, and more than 99% avoided pericardial effusion requiring intervention. More than 98% also avoided cardiovascular-related death, while 93.4% had no major bleeding during the first year of follow-up.
Why it matters
The findings add clinical data for Abbott's next-generation device, but Amulet 360 remains limited to investigational use in the U.S., so the results do not represent a U.S. commercial launch. Abbott received CE Mark approval for the device in August 2026.
Key facts
- 1The VERITAS pivotal study enrolled more than 450 patients at over 30 hospitals across the United States, Canada and Europe. prnewswire.com
- 2Complete left atrial appendage closure, defined as zero mm leak, occurred in 96.3% of patients assessed by transesophageal echocardiography. prnewswire.com
- 3More than 98% of patients had no ischemic stroke or systemic embolism through one year. prnewswire.com
- 4More than 99% of patients avoided pericardial effusion that required intervention. prnewswire.com
- 5A major bleeding event was absent during the first year for 93.4% of patients. prnewswire.com
- 6Amulet 360 is approved for investigational use only in the U.S. and received CE Mark approval in August 2026. prnewswire.com
Summary written by AlphAI AI Desk from 4 of 4 sources. Not investment advice. Figures are as stated by the linked sources.