Adagio Medical Holdings Inc. (NASDAQ:ADGM) said it has received Investigational Device Exemption (IDE) authorization from the U.S. Food and Drug Administration to expand its FULCRUM-VT clinical trial assessing the company’s next-generation vCLAS Ultra-Low Temperature Ablation Ventricular Ablation System for the treatment of Sustained Monomorphic Ventricular Tachycardia.
The approval enables Adagio to launch a clinical sub-study evaluating its upgraded vCLAS Ventricular Ablation platform, including the new vCLAS Ultra catheter. The catheter is capable of reaching ablation temperatures of around -170°C and has shown more than a 50% reduction in procedure time in preclinical testing compared with earlier versions.
“Ventricular tachycardia remains one of the most difficult arrhythmias to treat, with current ablation approaches often limited by difficulty achieving sufficient lesion depth,” said Dr. William Stevenson, Professor of Medicine at Vanderbilt University Medical Center. “We have been impressed with the safety and clinical results of the initial ULTA system for treating VT in patients with ischemic and nonischemic cardiomyopathies.”
The sub-study will be conducted as a prospective, single-arm, multi-center clinical trial aimed at generating safety and effectiveness data for treating scar-related SMVT in both ischemic and non-ischemic patients. The IDE expansion allows for the enrollment of 55 patients under a staged study design.
Adagio focuses on developing catheter-based Ultra-Low Temperature Ablation technology for the treatment of cardiac arrhythmias. Its vCLAS Cryoablation System already carries CE marking and is currently being evaluated in the ongoing FULCRUM-VT U.S. Pivotal IDE Trial.