Adagio Medical has received the CE Mark approval for its ultra-low temperature cryoablation (ULTC) system to treat monomorphic ventricular tachycardia (VT).
Headquartered in California, Adagio Medical develops cryoablation and catheter ablation technologies to treat cardiac arrhythmias, VT, and atrial fibrillation (AF).
The cryoablation system incorporates the upgraded cryoablation console, which can assist in atrial ablation procedures using commercially available iCLAS catheters, and the vCLAS ventricular cryoablation catheter.
According to Adagio Medical, the VT cryoablation system will be available immediately for clinical use in certain European centres.
The first-in-human use of ULTC technology was announced in July 2021 as part of a multi-centre trial.
Adagio Medical president and CEO Olav Bergheim said: “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.
“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.”
The Cryocure-VT trial enrolled 60 patients with monomorphic VT of ischemic as well as non-ischemic origin at nine centres in Europe and Canada.
Adagio Medical completed the recruitment of patients in May last year. The early acute results were published in 2023 and the full results inclusive of a follow-up at six months will be unveiled on 8 April 2024.
The 9Fr, bi-directional deflectable vCLAS catheter was created specifically to ease the difficulties associated with VT ablations.
The catheter is said to be suitable for a variety of purely endocardial ablation strategies in patients with ischemic as well as non-ischemic cardiomyopathies.
Its 15mm long ULTC ablation element can create lesions with titratable width and depth of more than 10mm, the cryoablation technologies developer said.
