October 10, 2025 — Leads & Copy — Adagio Medical Holdings, Inc. (Nasdaq: ADGM) has announced preliminary acute safety and efficacy results from its FULCRUM-VT Study. The study evaluated Ultralow Temperature Cryoablation (“ULTC”) for treating Sustained Monomorphic Ventricular Tachycardia (“SMVT”) in patients with ischemic and nonischemic cardiomyopathy. Travis Richardson, MD, presented the data at the 20th Annual International Symposium on Ventricular Arrhythmias in Philadelphia.
The study included 207 patients who underwent ventricular tachycardia (“VT”) ablation using Adagio’s ULTC system across 19 sites in the United States and Canada. The study included patients with both ischemic (“ICM”) and non-ischemic (“NICM”) cardiomyopathies (LVEF=35+/-10%, 33% NICM, 75% with congestive heart failure). The mean procedure duration was 206+/- 68 minutes, and acute clinical success, defined as non-inducibility of target ventricular arrhythmias, was 97.4%. All clinically-relevant ventricular tachycardias were eliminated in 96.7% of patients tested by post-ablation programmed electrical stimulation. Key safety findings included a 2.5% rate of major adverse events, including four (1.9%) peri-procedural deaths, of which one (0.5%) was adjudicated as definitely related to the investigational device.
According to Dr. Richardson, Adagio’s ULTC system’s ability to produce deep, titratable endocardial lesions without irrigation and concerns for catheter stability makes it promising for a broad patient population. Todd Usen, CEO of Adagio Medical, expressed pleasure with the preliminary data and thanked the investigators, research coordinators, and patients who supported the study.
The FULCRUM-VT Study is a prospective, multi-center investigation of ULTC evaluating acute safety and effectiveness in patients with scar-related VT refractory to antiarrhythmic drug therapy and a left ventricular ejection fraction greater than 20%.
Contact:
Travis Richardson, MD, Assistant Professor of Medicine, Clinical Cardiac Electrophysiology, Vanderbilt University Medical Center
Source: Adagio Medical Holdings, Inc.
