Adagio Medical Announces CE Mark approval of VT Cryoablation System, Plans for Immediate Commercialization in Select European Centers
The system consists of the upgraded cryoablation console, also capable of supporting atrial ablation procedures using commercially available iCLAS™ catheters, and the vCLAS™ ventricular cryoablation catheter ("vCLAS").
- The system consists of the upgraded cryoablation console, also capable of supporting atrial ablation procedures using commercially available iCLAS™ catheters, and the vCLAS™ ventricular cryoablation catheter ("vCLAS").
- The system will be featured at the upcoming conference of the European Heart Rhythm Association ("EHRA") in Berlin on April 7-9, 2024 and will become immediately available for clinical use in select European centers.
- Unlike conventional radiofrequency ("RF") catheters commonly used for both ventricular and atrial procedures, the 9Fr, bi-directional deflectable vCLAS catheter was designed specifically to address the challenges of VT ablations.
- CE Mark approval for the vCLAS catheter has been granted based on the results of the Cryocure-VT trial, which enrolled patients with monomorphic VT of both ischemic and non-ischemic origin at nine European and Canadian centers.