FDA Grants Breakthrough Status to Adagio Medical's Vclas™ System

Adagio Medical Holdings, Inc., specialising in catheter ablation technologies for cardiac arrhythmias, has received Breakthrough Device designation from the U.S. Food and Drug Administration for its vCLAS™ Cryoablation System. This system is being developed for the treatment of drug-resistant, recurrent, sustained monomorphic ventricular tachycardia (VT) in patients with either ischaemic or non-ischaemic structural heart disease.

The vCLAS™ Cryoablation System uses Adagio’s proprietary Ultra-Low Temperature Cryoablation (ULTC) technology. It has been specifically designed to improve the safety and success of VT ablation procedures and patient outcomes. In the United States, the technology is currently being studied under an IDE in a clinical trial named FULCRUM-VT.

The FDA Breakthrough Device Program is designed to speed up the development and review of medical devices that have the potential to offer more effective treatment or diagnosis for serious or life-threatening conditions. To qualify, a device must either represent a breakthrough technology, offer significant benefits over existing options, address an unmet medical need, or serve the best interests of patients.

With this designation, Adagio will receive priority review and closer collaboration with the FDA during the premarket review of the vCLAS™ Cryoablation System.

FULCRUM-VT is a prospective, multi-centre, open-label, single-arm study that will enrol 206 patients with structural heart disease caused by either ischaemic or non-ischaemic cardiomyopathy. All patients will be indicated for catheter ablation of VT that does not respond to drug therapy, following current clinical guidelines. The results of this study will support a future Premarket Approval (PMA) application to the FDA. If approved, the vCLAS™ Cryoablation System could receive the broadest indication in the industry for fully endocardial ablation of scar-related VT.