Adagio Medical Receives CE Mark for Ventricular Tachycardia Cryoablation System

Adagio Medical has received CE Mark approval for its ultra-low temperature cryoablation (ULTC) system for the treatment of monomorphic ventricular tachycardia. 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. It features a 15-millimeter long ULTC ablation element, capable of creating lesions with titratable width and depth exceeding 10 millimeters, making it time- and effort-efficient across the range of purely endocardial ablation strategies in patients with both ischemic and non-ischemic cardiomyopathies, including those with otherwise challenging mid-myocardial scarring. The use of cryogenic energy and associated cryoadhesion ensures catheter stability during ablation while the absence of catheter irrigation simplifies the hemodynamic management of patients who often present with symptoms of clinical heart failure.

Adagio is highly committed to the VT space, with the Cryocure-VT trial and CE Mark approval of vCLAS catheter being the first steps of the journey. Additional US studies are either ongoing or in planning. We are grateful to the Cryocure-VT investigators and are looking forward to engaging the European Electrophysiology community to maximize the potential of ULTC technology and patient benefit in VT ablations,” said Olav Bergheim, President and CEO of Adagio Medical.

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