Adagio Medical's VT Cryoablation System Cleared for European Launch After CE Mark Approval

Monday, March 25, 2024

Adagio Medical, a prominent player in catheter ablation technologies for ventricular tachycardia ("VT") and atrial fibrillation has announced the CE Mark approval for its innovative ultra-low temperature cryoablation ("ULTC") system designed specifically for treating monomorphic ventricular tachycardia. This advanced system comprises an upgraded cryoablation console that supports atrial ablation procedures using commercially available iCLAS™ catheters, in addition to the vCLAS™ ventricular cryoablation catheter ("vCLAS").

Unlike traditional radiofrequency ("RF") catheters used for both ventricular and atrial procedures, the vCLAS catheter is uniquely engineered to address the complexities of VT ablations. Featuring a 9Fr, bi-directional deflectable design, it boasts a 15-millimeter long ULTC ablation element capable of creating lesions with adjustable width and depth exceeding 10 millimeters. This facilitates efficient ablation strategies across a range of endocardial approaches in patients with both ischemic and non-ischemic cardiomyopathies, including those with challenging mid-myocardial scarring.

Cryogenic energy usage and cryoadhesion ensure catheter stability during ablation, while the absence of catheter irrigation simplifies hemodynamic management, especially for patients with heart failure symptoms. Adagio's dedication to the VT field is exemplified by the Cryocure-VT trial and the CE Mark approval of the vCLAS catheter, representing initial steps in this journey. Further studies in the United States are either underway or in planning stages.


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