The company will recruit up to 40 patients with monomorphic VT of both ischemic and non-ischemic origin in the study
The company has reported the first-in-human use of ULTC technology in Belgium. (Credit: Raman Oza from Pixabay)
Adagio Medical has commenced the multi-centre trial of ultra-low temperature cryoablation (ULTC) technology to treat recurrent ventricular tachycardia (VT).
The company has reported the first-in-human use of ULTC technology in Belgium for the treatment of monomorphic VT.
Cardiovascular Center OLV Hospital’s cardiovascular centre department of cardiology and electrophysiology section associate director Dr Tom De Potter has conducted the two-hour mapping and ablation procedure.
According to the company, procedural success was assessed by the lack of the inducible arrhythmia following the delivery of a set of ULTC lesions to isolate inferior-posterior ischemic scar in patient’s left ventricle.
The company will recruit up to 40 patients with monomorphic VT of both ischemic and non-ischemic origin at six academic medical centres in Europe and Canada in the VT Cryoablation study.
Adagio president and CEO Olav Bergheim said: “This first procedure marks the beginning of a prospective, multi-center study for Adagio’s VT Cryoablation System, which will support future CE-mark submission.
“The system leverages our unique iCLAS platform technology for the ablation of atrial arrythmias which is commercially available in Europe and is undergoing FDA IDE trial in the US. The VT catheter is designed to meet stringent anatomic and physiologic requirements of ventricular ablations.”
Adagio Medical is involved in the development of cryoablation technologies to create continuous, linear and transmural lesions for the treatment of cardiac arrhythmias.
In November last year, the company raised $42.5m Series E equity financing to support its iCLAS Investigational Device Exemption (IDE) trial.
The funding was also planned to be utilised for the development and clinical validation of its pulsed field cryoablation (PFCA) technology.
In December 2019, Adagio Medical announced the recruitment of the first patient in its iCLAS IDE trial.