Adagio Medical reports six-month results from Fulcrum-VT IDE trial

Adagio Medical (ADGM) reported six month results from its Fulcrum-VT Investigational Device Exemption, IDE, clinical trial, which will be used to support the Company’s application for Food and Drug Administration, FDA, Premarket Approval of the vCLAS Ventricular Ablation System. The results were presented today in a late-breaking clinical trial session at the Heart Rhythm Society 2026 conference. Key findings included: 98% non-inducibility of targeted ventricular tachycardias at end of procedure; Promising safety profile with 2.4% protocol-defined Major Adverse Events; 84% freedom from implantable cardioverter defibrillator shock at 6 months; 59% freedom from any VT recurrence at 6 months; Equivalent results for ischemic and non-ischemic cardiomyopathy patients; Over 80% reduction in number of patients experiencing ICD shock over 6-months post ablation compared to equivalent time period pre-ablation; 72% of patients discontinued or reduced dose of amiodarone at 6 months; Low 1.9% rate of 30-day VT-related hospital readmission