Initial Procedures Completed in Ventricular Tachycardia Cryoablation System Trial

Adagio Medical Holdings Inc. has completed the first procedures in a U.S. Food and Drug Administration (FDA) Pivotal IDE study of its VT Cryoablation System.

FULCRUM-VT (Feasibility of Ultra-Low Temperature Cryoablation in Recurring Monomorphic Ventricular Tachycardia) 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. Study results will be used to obtain FDA premarket approval (PMA) for Adagio’s VT Cryoablation System with the vCLAS cryoablation catheter, reportedly the broadest indication in the industry for purely endocardial ablation of scar-mediated VT.

“We are pleased to partner with top academic institutions to bring a long-overdue innovation in VT ablation technology to patients in the U.S.,” Adagio President/CEO Olav Bergheim said. “FULCRUM-VT received Medicare coverage approval from the Center for Medicare and Medicaid Services (CMS) and study approval from Health Canada. We are now focused on accelerating patient enrollment at all study sites. The European launch of vCLAS is also accelerating, with a growing number of centers evaluating ULTC technology across the spectrum of VT etiologies and patient presentations.”

Procedures were performed by Professor William G. Stevenson, M.D., at Vanderbilt University Medical Center in Nashville, Tenn.; and Dr. J. David Burkhardt at Texas Cardiac Arrhythmias Institute (TCAI) in Austin, Texas.

“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 cardiac arrhythmia treatment. “The procedures mark the expansion of the program to 20 centers in the U.S. and Canada, allowing for the 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.”

The Adagio Medical VT Cryoablation System with the vCLAS cryoablation¹ catheter is based on the company’s proprietary ultra-low temperature cryoablation (ULTC) technology and was designed specifically to address both safety and effectiveness challenges of VT ablation by creating large and deep endocardial lesions with minimal attenuation by scar tissue² without the need for catheter irrigation, a known risk for acute heart failure in patients undergoing RF ablations. The system gained CE-Mark approval and is commercially available in select European countries.

“This was TCAI’s first experience with Adagio’s system,” added Dr. Burkhardt, “and we successfully and safely ablated a non-ischemic scar in tissue with depth exceeding 10 mm in the proximity of the artificial transcatheter aortic valve, which limited the achievable depth of other available technologies. This gives us confidence and motivation as we continue with study enrollment.”

Adagio Medical is an early commercial stage medical device company located in Laguna Hills, Calif., developing cryoablation technologies that create contiguous, transmural lesions to treat cardiac arrhythmias, including paroxysmal and persistent atrial fibrillation, atrial flutter, and ventricular tachycardia.

References
¹ The Adagio Medical, Inc. VT Cryoablation System (Catheter and Console) is indicated for the treatment of monomorphic ventricular tachycardia by ablation of arrhythmogenic tissues that drive and maintain these arrhythmias. The vCLAS™ Cryoablation Catheter, a component of the Adagio Medical, Inc. VT Cryoablation System is intended to create transmural linear and focal lesions to cardiac structures within the endocardium of the ventricles with cryoablation. Adagio Medical, Inc. PM-006 Rev. E
² Dewland TA, Higuchi S, Venkateswaran R, Lee C, Gerstenfeld EP. AB-452672-2 Ultra-low Temperature Cryoablation Versus Ultra-low Temperature Cryoablation Combined With Pulsed Field Ablation In A Swine Ventricular Infarct Model. Heart Rhythm 2023;20:S92-S93. https://doi.org/10.1016/j.hrthm.2023.03.395