Adagio Medical Holdings, Inc. (ADGM) reported that the results of its U.S. Early Feasibility Study (EFS) for the vCLAS Cryoablation System were published in Circulation: Arrhythmia and Electrophysiology on February 4 2026. The study enrolled 20 patients with scar‑related ventricular tachycardia (VT) at four U.S. tertiary centers and found no device‑ or procedure‑related major adverse events at both seven‑ and 30‑day follow‑up.
The clinical data showed that 92.9% of patients with inducible VT became non‑inducible after ablation. At a mean follow‑up of 24 weeks, 72% of patients either discontinued or reduced antiarrhythmic drugs, and 83.3% were free from implantable cardioverter‑defibrillator (ICD) shocks. These outcomes mirror the encouraging results of the European CRYOCURE‑VT trial and reinforce the company’s claim that its ultra‑low‑temperature cryoablation technology can create deep, durable lesions in the ventricle.
The EFS publication is a key milestone for the FULCRUM‑VT pivotal trial, which completed enrollment in October 2025 with 208 patients across 20 U.S. and Canadian centers. The trial’s preliminary acute results, presented in October 2025, showed 97.4% acute clinical success and a 2.5% rate of major adverse events. The EFS data will be incorporated into the safety analyses for the FULCRUM‑VT trial and support the company’s strategy to secure FDA pre‑market approval by the end of 2026.
CEO Todd Usen said the study “marks an important milestone for Adagio Medical and for patients with complex ventricular arrhythmias. These results highlight the potential of ultralow temperature ablation to address a significant unmet need in VT treatment and underscore the value of the FDA’s Early Feasibility Study program in accelerating patient access to innovative technologies.” Dr. J. Peter Weiss, the study’s corresponding author, added that the technology’s ability to produce deep, titratable lesions is essential for treating the deep intramural substrate that drives many drug‑refractory VTs.
The vCLAS Cryoablation System uses near‑critical nitrogen to reach temperatures approaching –196 °C, enabling lesion depth that exceeds conventional radiofrequency ablation. The positive safety and efficacy profile, combined with the system’s Breakthrough Device designation received in April 2025, positions Adagio to advance the product through the U.S. regulatory pathway and potentially capture a growing market for VT ablation solutions.
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