Adagio completes first procedures in FULCRUM-VT IDE of VT cryoablation system

Adagio Medical (ADGM) Holdings announced the completion of the first procedures in FULCRUM-VT U.S. Food and Drug Administration FDA Pivotal IDE study of Adagio’s VT Cryoablation System. Procedures were performed by Professor William G. Stevenson, MD, at Vanderbilt University Medical Center in Nashville, TN and Dr. J. David Burkhardt at Texas Cardiac Arrhythmias Institute TCAI at Austin, TX. FULCRUM-VT is a prospective, multi-center, open-label, single-arm study, enrolling 206 patients with structural heart disease of both ischemic and non-ischemic cardiomyopathy, indicated for catheter ablation of drug refractory ventricular tachycardia VT in accordance with current treatment guidelines. The results of the study will be used to obtain FDA premarket approval PMA for Adagio’s VT Cryoablation System with the vCLAS cryoablation catheter with industry broadest indication for purely endocardial ablation of scar-mediated VT…”Our center enrolled six patients in the Early Feasibility stage of FULCRUM-VT program, with encouraging results,” said Dr. Stevenson, a world-renowned expert in the treatment of cardiac arrhythmias. “Today’s procedures mark the expansion of the program to 20 centers in the US and Canada, allowing for the robust evaluation of Adagio’s technology in a large and challenging population of patients with structural heart disease. The only approved ablation option we can currently offer these patients is based on radiofrequency, or RF energy, which has well-known limitations for ablations in thicker cardiac tissue and when managing patients at risk of cardiac decompensation, the limitations this system may help overcome.”