Adagio Medical Holdings (NASDAQ:ADGM) unveiled positive six-month results from its FULCRUM-VT clinical trial on Monday, providing the foundational data required for its forthcoming Food and Drug Administration (FDA) Premarket Approval application.
The findings, presented during a late-breaking session at the Heart Rhythm Society 2026 conference, evaluate the efficacy of the company’s vCLAS Ventricular Ablation System in treating cardiac arrhythmias.
The trial met high benchmarks for procedural success, achieving 98% non-inducibility of targeted ventricular tachycardias (VT) by the end of the procedure.
At the six-month mark, 84% of participants remained free from implantable cardioverter defibrillator (ICD) shocks, representing an 80% reduction in patients experiencing such shocks compared to the six months prior to ablation.
Furthermore, 59% of patients reported total freedom from any VT recurrence, a metric that includes anti-arrhythmic drug escalation and antitachycardia pacing.
From a safety and recovery perspective, the vCLAS system maintained a 2.4% rate of protocol-defined Major Adverse Events and a low 1.9% rate of 30-day VT-related hospital readmissions.
Notably, the clinical benefits were consistent across both ischemic and non-ischemic cardiomyopathy patients.
The data also highlighted a significant shift in patient medication management, with 72% of participants able to either reduce or entirely discontinue their dose of amiodarone.
These results position Adagio to move forward with regulatory filings as it seeks to commercialize its ultra-low temperature cryoablation technology in the U.S. market.