Adagio submits PMA to FDA for vCLAS VT ablation system; trial shows 97.4% acute success

Adagio Medical Holdings, Inc.

PMA application for vCLAS Ventricular Ablation System to treat drug-refractory VT in structural heart disease.
FULCRUM-VT pivotal trial (209 patients, 20 centers) achieved 97.4% acute clinical success and 84.3% freedom from ICD shock at 6 months.
Major adverse events rate of 2.4%; 78% reduction or elimination of anti-arrhythmic drug use.
First-ever PMA submission for a purpose-built VT ablation system; estimated addressable market of $5.8 billion.
CEO Todd Usen states vCLAS endocardial-only approach could democratize VT ablation for electrophysiologists.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.