Adagio Medical announces preliminary acute results from FULCRUM-VT study

Adagio Medical (ADGM) announced preliminary acute safety and efficacy results from Adagio’s FULCRUM-VT Study evaluating Ultralow Temperature Cryoablation for the treatment of Sustained Monomorphic Ventricular Tachycardia in patients with both ischemic and nonischemic cardiomyopathy. The data are being presented by Travis Richardson, MD, Assistant Professor of Medicine, Clinical Cardiac Electrophysiology, Vanderbilt University Medical Center, in a Late Breaking Clinical Trials Session at the 20th Annual International Symposium on Ventricular Arrhythmias being held in Philadelphia on October 10. A total of 207 patients underwent ventricular tachycardia ablation using Adagio’s ULTC system at 19 sites in the United States and Canada. The study included patients with both ischemic and non-ischemic cardiomyopathies. Mean procedure duration was 206+/- 68 minutes and acute clinical success, defined as non-inducibility of target ventricular arrhythmias, was 97.4%, with all clinically-relevant ventricular tachycardias 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 peri-procedural deaths, of which one was adjudicated by an independent clinical events committee as definitely related to the investigational device.