Adagio Medical receives FDA Breakthrough Device designation for vCLAS system

Adagio Medical (ADGM) announced it received Breakthrough Device designation from the FDA for its vCLAS Cryoablation System. The designation is for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia in patients with structural heart disease. The system uses the company’s Ultra-Low Temperature Cryoablation technology and allows for priority FDA review. The vCLAS system is currently under evaluation in the FULCRUM-VT U.S. IDE study. “Receiving Breakthrough Device Designation is an important milestone for Adagio, validating our proprietary vCLASTM Cryoablation System with our ULTC technology as a potentially unique solution for the large, underserved population of patients suffering from ventricular tachycardia,” said Todd Usen, Chief Executive Officer of Adagio. “Our team has been working hard to bring this transformational technology to patients, and we are thrilled to be the only technology to be granted Breakthrough Device designation for endocardial treatment of both ischemic and nonischemic structural heart disease patients with sustained monomorphic VT. We are encouraged that, based in part on the strength of the clinical data from our European CRYOCURE-VT study, the FDA has determined that vCLASTM qualifies as a Breakthrough Device, and we look forward to working collaboratively with the agency to make the vCLASTM System available to U.S. physicians and patients as expeditiously as possible.”