- Adagio Medical Holdings (ADGM, Financial) receives FDA Breakthrough Device designation for its vCLAS™ Cryoablation System.
- The vCLAS™ system targets ventricular tachycardia and is currently under evaluation in the FULCRUM-VT IDE study with 206 patients.
- Commercially available in Europe, the system is for investigational use in the US pending FDA approval.
Adagio Medical Holdings, Inc. (ADGM), announced that it has received the FDA Breakthrough Device designation for its vCLAS™ Cryoablation System. This system is designed for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia in patients with ischemic or non-ischemic structural heart disease. The innovative technology employs proprietary Ultra-Low Temperature Cryoablation (ULTC) and is undergoing evaluation in the FULCRUM-VT IDE study, which includes 206 enrolled patients.
The FDA's Breakthrough Device designation is anticipated to facilitate priority review and improve communication during the premarket review, potentially expediting the system's approval timeline. The clinical trial results will support Adagio's premarket approval application aiming for a broad industry indication for endocardial ablation of scar-mediated ventricular tachycardia (VT). While the vCLAS™ system is commercially available in Europe and select regions, it remains limited to investigational use within the United States pending approval.
Todd Usen, CEO of Adagio, emphasized the importance of this designation as it validates the unique capabilities of the vCLAS™ Cryoablation System for the treatment of structural heart disease. This FDA recognition underscores the value of addressing unmet medical needs in patients with ventricular tachycardia, promising improved safety and effectiveness in VT ablations.
The FULCRUM-VT study aims to provide the evidence necessary for FDA premarket approval, potentially setting the stage for Adagio's system to access the US market more rapidly than through traditional pathways.
