Adagio Medical Submits PMA Application to FDA for vCLAS Ventricular Ablation System

Adagio Medical Holdings, Inc. announced the submission of a Premarket Approval (PMA) application to the FDA for its vCLAS Ventricular Ablation System for treating drug-refractory ventricular tachycardia. The submission marks the first PMA for a purpose-built VT ablation system targeting a $5.8 billion market. The application is supported by data from the FULCRUM-VT pivotal trial involving 209 patients across 20 centers, which demonstrated 97.4% acute clinical success, 84.3% freedom from ICD shocks, and 78% reduction in anti-arrhythmic drug use. The system previously received Breakthrough Device Designation and addresses both ischemic and non-ischemic cardiomyopathy patients, representing a significant advancement in cardiac arrhythmia treatment.