Adagio Medical has announced the first ultra-low temperature cryoablation (ULTC) procedure with the Adagio vCLAS catheter system in the US.
The procedure with the device has been carried out as part of the Feasibility of Ultra-Low Temperature Cryoablation for Recurring Monomorphic Ventricular Tachycardia (FULCRUM-VT) clinical study.
Dr Roderick Tung performed the procedure at Banner-University Medical Center in Phoenix, Arizona.
Tung said: “The ability of ULTC to create lesions deeper than the average thickness of ventricular myocardium exclusively from the endocardial surface in pre-clinical models is a major potential advantage.”
The trial will enrol 20 patients across four investigational sites, including Vanderbilt University Hospital in Nashville, Mount Sinai Hospital in New York, the University of California in San Francisco, and Banner-University Medical Center.
Its enrolment criteria include both ischemic and non-ischemic heart disease, an indication for ventricular ablation due to recurrent symptomatic monomorphic VTs and an implanted cardioverter defibrillator.
Additionally, the study will include patients for both de-novo and first-repeat ablation.
Adagio Medical president and CEO Olav Bergheim said: “The initiation of the FULCRUM-VT study is the first step towards bringing Adagio’s ULTC platform technology to the VT ablations market in the US.”
The CRYOCURE-VT trial in Europe and Canada, with 64 patients, to assess the safety and performance of the vCLAS catheter, has concluded enrolment and this data will be utilised to receive CE-Mark approval for the device.