Adagio Wins FDA Breakthrough Nod for vCLAS Cryoablation System

Adagio Medical Holdings, a company focused on catheter ablation tech to treat cardiac arrhythmias, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its vCLAS cryoablation system to treat drug-refractory, recurrent, sustained monomorphic ventricular tachycardia (VT) in patients with ischemic or non-ischemic structural heart disease.

vCLAS is currently amid the FULCRUM-VT investigational device exemption (IDE) study. It uses the company’s Ultra-Low Temperature Cryoablation (ULTC) technology and is designed to improve the safety and effectiveness of VT ablations and patient outcomes. It is enrolling 206 patients with structural heart disease of both ischemic and non-ischemic cardiomyopathy, indicated for catheter ablation of drug refractory VT in accordance with current treatment guidelines.

Results of this study will be used to submit for FDA premarket approval. This could lead to the broadest industry indication for purely endocardial ablation of scar-mediated VT.

“Receiving Breakthrough Device Designation is an important milestone for Adagio, validating our proprietary vCLAS 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, CEO 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.”

The FDA will provide the company with priority review and interactive communication during vCLAS’ premarket review phase.

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 vCLAS 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,” said Usen.