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Adagio Medical Announces CE Mark Approval of VT Cryoablation System, Plans for Immediate Commercialization in Select European Centers

Adagio Medical Press Release

03/25/2024

LAGUNA HILLS, Calif., March 25, 2024 /-- Adagio Medical, Inc., a leading innovator in catheter ablation technologies for ventricular tachycardia (VT) and atrial fibrillation (AF), today announced CE Mark approval of 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,¹ including those with otherwise challenging mid-myocardial scarring.² 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.

"We are encouraged by the commercial availability of the dedicated VT ablation system in our European centers, as it shows promise for patients with ventricular arrhythmias," said Professor Dr. KR Julian Chun of Cardiovascular Center Bethanien ("CCB") in Frankfurt, Germany. "The current VT ablation practice has evolved around generic catheter tools available to the clinicians, with all associated trade-offs, limiting, to an extent, how broadly we offer ablations to a rather sick patient population with structural heart disease," added Professor Dr. Boris Schmidt, an Electrophysiologist at CCB. "We now have the opportunity to thoroughly evaluate Adagio's ULTC technology in both routine clinical practice and post-market studies to see the impact it will have on our patient selection, procedural approaches and outcomes."

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. The early acute results of the trial were published in the Journal of American College of Cardiology: Clinical Electrophysiology in 2023¹, and the full results inclusive of six months follow-up will be presented on April 8, 2024, at EHRA's Late-Breaking Clinical Science session by Dr. Atul Verma, MD, the Director of the Division of Cardiology at McGill University Health Centre.

"We believe that the unique features and performance of ULTC will advance the field of VT ablations with outcomes warranting expansion of patient eligibility and earlier intervention," said Olav Bergheim, President and CEO of Adagio Medical, Inc. "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".

¹De Potter T, Balt J, Boersma L, Sacher F, et al. First-In-Human Experience with Ultra-Low Temperature Cryoablation for Monomorphic Ventricular Tachycardia. J Am Coll Cardiol EP 2023;9:686-61

²Dilk P, Darma A, Hindricks G, Dinov B. Ultra-low-temperature cryoablation for ventricular tachycardia in nonischemic cardiomyopathy – a case report. Heart Rhythm Case Reports 2023;9:469-472

About Adagio Medical, Inc.

Adagio Medical, Inc. is a privately held company located in Laguna Hills, California developing innovative cryoablation technologies that create contiguous, transmural lesions to treat cardiac arrhythmias, including paroxysmal and persistent atrial fibrillation, atrial flutter, and ventricular tachycardia.

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