Adagio’s vCLAS Cryoablation System Receives FDA Breakthrough Device Designation

April 17, 2025—Adagio Medical Holdings, Inc. announced that it has received FDA Breakthrough Device designation for its vCLAS cryoablation system for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia (VT) in patients with ischemic or nonischemic structural heart disease.

Under the Breakthrough Device program, the FDA will provide Adagio with priority review and interactive communication during the vCLAS system’s premarket review phase, noted the company.

According to Adagio, vCLAS is a purpose-built system using the company’s ultra-low-temperature cryoablation technology. It is designed to improve the safety and effectiveness of VT ablations and patient outcomes.

Adagio advised that the vCLAS system is currently being evaluated in the United States pivotal FULCRUM-VT investigational device exemption study.

The company stated that FULCRUM-VT is a prospective, multicenter, open-label, single-arm study. It is enrolling 206 patients with structural heart disease of both ischemic and nonischemic cardiomyopathy, indicated for catheter ablation of drug-refractory VT in accordance with current treatment guidelines.

The results of the study will be used to apply for FDA premarket approval for vCLAS, which is currently limited to investigational use in the United States.

Adagio’s vCLAS cryoablation system has received CE Mark approval and is commercially available for the treatment of monomorphic VT in Europe and select other geographies, stated the company.