Adagio Medical Holdings Inc. has announced the publication of results from its U.S. Early Feasibility Study (EFS) evaluating ultralow temperature cardiac ablation (ULTC) for the treatment of scar-related ventricular tachycardia $(VT)$. The study, available in Circulation: Arrhythmia and Electrophysiology, represents the first published U.S. clinical experience for ULTC under the FDA’s Early Feasibility Study framework. Patients enrolled in the EFS will be included in the safety analyses of Adagio Medical's FULCRUM-VT pivotal Investigational Device Exemption $(IDE)$ study, which completed enrollment in October 2025. The FULCRUM-VT pivotal trial results are expected to be presented at the Heart Rhythm Society scientific meeting in April. Adagio's ULTC technology utilizes near-critical nitrogen to achieve temperatures approaching -196°C, aiming to create deeper and potentially transmural lesions compared to existing ablation modalities. Regulatory approval of the vCLASTM Cryoablation System is anticipated by the end of 2026.

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