ADGM News & Events

Adagio Medical announced the submission of its Premarket Approval, PMA, application to the U.S. Food and Drug Administration, FDA, for the vCLAS Ventricular Ablation System for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia in patients with ischemic or non-ischemic structural heart disease. The PMA submission is supported by the Fulcrum-VT pivotal IDE trial, a single-arm study that enrolled 209 patients across 20 leading electrophysiology centers. The trial achieved 97.4% acute clinical success and demonstrated compelling 6-month outcomes, including 84.3% freedom from ICD shock, only 2.4% major adverse events and a 78% reduction or elimination of anti-arrhythmic drug use. Importantly, vCLAS demonstrated equivalent clinical effectiveness in both ischemic and non-ischemic cardiomyopathy, addressing the largest unmet need in VT ablation today.

"The first quarter of 2026 was a landmark period for Adagio during which we made exceptional progress advancing our Ultra-Low Temperature Ablation platform across both clinical development and real-world use," said Todd Usen, Chief Executive Officer of Adagio Medical. "The late-breaking results from the FULCRUM-VT trial represent a defining milestone for our endocardial-only ULTA platform, demonstrating best-in-class safety, 84% freedom from ICD shock at six months, meaningful reductions in antiarrhythmic drug use, and consistent results across both ischemic and non-ischemic cardiomyopathy patients-the broadest patient population studied in any VT ablation trial. The enthusiasm from physicians on the podium was remarkable, with leading electrophysiologists highlighting ULTA as a potentially transformative solution for ventricular tachycardia. As we look ahead, we have multiple additional meaningful milestones expected this year across our platform of technologies and we are more confident than ever in our mission to fundamentally change the treatment of VT with a safe, effective solution for a broad group of patients who suffer from this dangerous arrhythmia."

Adagio Medical reported six month results from its Fulcrum-VT Investigational Device Exemption, IDE, clinical trial, which will be used to support the Company's application for Food and Drug Administration, FDA, Premarket Approval of the vCLAS Ventricular Ablation System. The results were presented today in a late-breaking clinical trial session at the Heart Rhythm Society 2026 conference. Key findings included: 98% non-inducibility of targeted ventricular tachycardias at end of procedure; Promising safety profile with 2.4% protocol-defined Major Adverse Events; 84% freedom from implantable cardioverter defibrillator shock at 6 months; 59% freedom from any VT recurrence at 6 months; Equivalent results for ischemic and non-ischemic cardiomyopathy patients; Over 80% reduction in number of patients experiencing ICD shock over 6-months post ablation compared to equivalent time period pre-ablation; 72% of patients discontinued or reduced dose of amiodarone at 6 months; Low 1.9% rate of 30-day VT-related hospital readmission