ADGM · Adagio Medical Holdings, Inc.

Adagio Medical's announcement of positive pivotal results from the FULCRUM-VT IDE trial marks a critical milestone for its vCLAS Ventricular Ablation System, demonstrating robust clinical effectiveness and safety in treating drug-refractory ventricular tachycardia (VT) in patients with structural heart disease. The trial's key endpoints—98% non-inducibility of targeted VT at procedure end, 84% freedom from ICD shocks, and 59% freedom from any VT recurrence at six months—were achieved with a low 2.4% rate of protocol-defined major adverse events, including only 1.0% possibly device-related peri-procedural deaths as adjudicated by an independent committee. Notably, outcomes were equivalent between ischemic cardiomyopathy (ICM: 84% shock-free, 61% device intervention-free) and non-ischemic cardiomyopathy (NICM: 85% shock-free, 63% device intervention-free) cohorts, a first for endocardial ablation technologies addressing these challenging substrates. Additional benefits include over 80% reduction in patients needing ICD shocks versus pre-ablation, 72% amiodarone de-escalation, and a 1.9% 30-day VT readmission rate, highlighting potential for improved patient outcomes and reduced healthcare burden. With mean ablation time of 54 minutes and 11.5 lesions per patient, the procedure supports a streamlined workflow without irrigation or nitroglycerin risks. These results, consistent with prior ULTA studies and presented at the Heart Rhythm Society 2026 conference, position vCLAS for FDA Premarket Approval submission, targeting VT responsible for ~300,000 annual US sudden cardiac deaths. The system's CE Mark in Europe underscores its commercial viability outside the US, where it remains investigational.