Clinical TrialApr 27, 2026, 06:09 AM
ADGM vCLAS System: Positive Pivotal Trial Results for VT Ablation
AI Summary
Adagio Medical Holdings, Inc. announced positive six-month results from its FULCRUM-VT pivotal IDE clinical trial for the vCLAS® Ventricular Ablation System. The trial met safety and effectiveness endpoints, showing 84% freedom from ICD shock and 59% freedom from VT recurrence, with equivalent outcomes for both ischemic and non-ischemic cardiomyopathy patients. These results will support the Company's FDA Premarket Approval application, positioning vCLAS as a potential foundational technology for treating ventricular tachycardia.
Key Highlights
- 98% non-inducibility of targeted ventricular tachycardias at end of procedure.
- 84% freedom from implantable cardioverter defibrillator (ICD) shock at 6 months.
- 59% freedom from any VT recurrence at 6 months.
- Promising safety profile with 2.4% protocol-defined Major Adverse Events.
- Equivalent effectiveness shown for ischemic and non-ischemic cardiomyopathy patients.
- 72% of patients discontinued or reduced amiodarone at 6 months.
- Over 80% reduction in ICD shocks post-ablation compared to pre-ablation.
- Low 1.9% rate of 30-day VT-related hospital readmission.