USFDAMay 21, 2026, 04:38 PM
Adagio Medical Submits PMA to FDA for vCLAS® Ventricular Ablation System
AI Summary
Adagio Medical Holdings, Inc. announced the submission of its Premarket Approval (PMA) application to the U.S. FDA for its vCLAS® Ventricular Ablation System. This system is intended for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia (VT) in patients with structural heart disease. The submission is backed by data from the FULCRUM-VT pivotal trial, which enrolled 209 patients and showed 97.4% acute clinical success and compelling 6-month outcomes, including 84.3% freedom from ICD shock and a significant reduction in anti-arrhythmic drug use.
Key Highlights
- Adagio Medical submitted Premarket Approval (PMA) application to FDA for vCLAS® Ventricular Ablation System.
- The vCLAS system is designed for drug-refractory, recurrent, sustained monomorphic ventricular tachycardia (VT).
- PMA submission is supported by FULCRUM-VT pivotal IDE trial data from 209 patients across 20 centers.
- The trial achieved 97.4% acute clinical success.
- Demonstrated 84.3% freedom from ICD shock at 6 months.
- Reported only 2.4% major adverse events.
- Showed a 78% reduction or elimination of anti-arrhythmic drug (AAD) use.
- vCLAS demonstrated equivalent clinical effectiveness in both ischemic and non-ischemic cardiomyopathy.
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