February 4, 2026 — Leads & Copy — Adagio Medical Holdings, Inc. (Nasdaq: ADGM) has announced the publication of results from its U.S. Early Feasibility Study (EFS), which evaluated ultralow temperature cardiac ablation (ULTC) for treating scar-related ventricular tachycardia (VT).
The study, which was published in Circulation: Arrhythmia and Electrophysiology, was a prospective, multi-center study conducted under the U.S. Food and Drug Administration’s (FDA) EFS program. It enrolled 20 patients with both ischemic and non-ischemic cardiomyopathy across four U.S. tertiary referral centers.
Researchers assessed the acute safety and performance of ULTC ablation in patients with drug-refractory scar-related VT. The results indicated a favorable safety profile, with no device- or procedure-related major adverse events reported at both seven and 30 days.
The study also demonstrated strong acute and chronic performance. Among 14 patients with inducible VT tested before and after ablation, 92.9% achieved non-inducibility of targeted clinical VT. At a mean follow-up of 24 weeks, 72% of patients either completely discontinued or reduced their antiarrhythmic drugs, and 83.3% were free from implantable cardioverter-defibrillator (ICD) shock, with a reduction in the overall VT burden.
Dr. J. Peter Weiss, Associate Professor of Medicine at the University of Arizona College of Medicine–Phoenix and corresponding author of the study, said that Adagio’s ULTC technology’s advantage in VT ablation, compared to conventional technologies, is its ability to produce deep, titratable lesions. He added these are required to treat patients with deep intramural substrate causing their VT. Weiss noted the EFS results mirrored the CRYOCURE-VT European study results, but in a more challenging, heavily non-ischemic patient population and with aggressive antiarrhythmic medication de-escalation.
Adagio’s ULTC technology uses near-critical nitrogen to reach temperatures near -196°C, potentially creating deeper and transmural lesions than other ablation methods. This study marks the first published U.S. clinical experience for ULTC under the FDA’s EFS framework.
Todd Usen, Chief Executive Officer of Adagio Medical, said the study’s publication is a milestone for Adagio Medical and VT patients. He added that the results highlight ULTC’s potential to address a significant unmet need in VT treatment and underscores the value of the FDA’s Early Feasibility Study program. The company intends to share the results of its FULCRUM-VT pivotal trial at the Heart Rhythm Society scientific meeting in April.
Patients from the EFS will be included in the safety analyses of Adagio Medical’s FULCRUM-VT pivotal Investigational Device Exemption (IDE) study. FULCRUM-VT, which completed enrollment in October 2025, is designed to support U.S. regulatory approval of Adagio’s vCLASTM Cryoablation System, which is expected by year end 2026.
FULCRUM-VT (Feasibility of Ultralow Temperature Cryoablation in Recurring Monomorphic Ventricular Tachycardia) is a prospective, multi-center, open-label, single-arm trial. It enrolled 209 patients with structural heart disease of both ischemic and non-ischemic cardiomyopathy, indicated for catheter ablation of drug refractory VT per current treatment guidelines.
Adagio’s vCLAS™ Cryoablation System is commercially available in Europe and select other geographies for monomorphic VT treatment but is limited to investigational use in the United States.
The full publication is available online at: https://www.ahajournals.org/doi/10.1161/CIRCEP.125.014095
Source: Adagio Medical Holdings, Inc
