Adagio Medical has 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 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 15mm ULTC ablation element, capable of creating lesions with titratable width and depth exceeding 10mm, 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.
“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 Julian Chun (Cardiovascular Center Bethanien, 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 Boris Schmidt (Cardiovascular Center Bethanien, Frankfurt, Germany). “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 ischaemic and non-ischaemic origin at nine European and Canadian centres.
The early acute results of the trial were published in the Journal of American College of Cardiology: Clinical Electrophysiology in 2023, and the full results inclusive of six months follow-up will be presented at the European Heart Rhythm Association (EHRA) annual meeting (7–9 April, Berlin, Germany) by Atul Verma (McGill University Health Centre, Montreal, Canada).
“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. “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 maximise the potential of ULTC technology and patient benefit in VT ablations.”
