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    Adagio Medical Announced the Publication of Results From the US Early Feasibility Study Evaluating Ultralow Temperature Cardiac Ablation for Scar-related Ventricular Tachycardia

    Benzinga·02/04/2026 13:10:13
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    • Results demonstrated a favorable safety profile, with no device- or procedure-related major adverse events measured at both seven and 30 days, and strong acute and chronic performance. Among 14 patients with inducible VT tested both before and after ablation, 92.9% achieved non-inducibility of targeted clinical VT. At a mean follow-up of 24 weeks, antiarrhythmic drugs were either completely discontinued or reduced in 72% of the patients, and 83.3% of the patients were free from implantable cardioverter-defibrillator (ICD) shock, with a notable reduction in the overall VT burden.
    • Adagio's proprietary ULTC technology utilizes near-critical nitrogen to achieve temperatures approaching –196°C, enabling the creation of deeper and potentially transmural lesions compared with other existing ablation modalities. This study represents the first published U.S. clinical experience for ULTC under the FDA's EFS framework.
    • "The publication of this study marks an important milestone for Adagio Medical and for patients with complex ventricular arrhythmias," said Todd Usen, Chief Executive Officer of Adagio Medical. "These results highlight the potential of ultralow temperature ablation to address a significant unmet need in VT treatment and underscores the value of the FDA's Early Feasibility Study program in accelerating patient access to innovative technologies. We look forward to sharing the results of our FULCRUM-VT pivotal trial at the Heart Rhythm Society scientific meeting in April.
    • Patients enrolled in 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,