1 August 2023 – Minneapolis, MN United States – Imricor Medical Systems, Inc. (Company or Imricor) (ASX: IMR), the global leader in real-time iCMR cardiac ablation products, is pleased to announce it has received approval from the Medical Ethics Review Committee, Leiden The Hague Delft (METC LDD) to begin the VISABL-VT trial at Haga Hospital in The Hague, Netherlands.
The VISABL-VT trial is a prospective, single-arm, multi-centre investigation of the safety and efficacy of radiofrequency (RF) ablation of ventricular tachycardia (VT) associated with ischemic cardiomyopathy performed with the Vision-MR Ablation Catheter 2.0 in the iCMR environment. The study calls for treating 64 patients and includes a six-month follow-up for each patient. The study is intended to support CE mark certification of the Vision-MR Ablation Catheter 2.0 for treating VT.
The first patient to be enrolled in VISABL-VT is identified, and the first procedure is expected to take place in mid-August, upon the return of physicians and medical staff from summer holiday.
Imricor’s Chair and CEO, Steve Wedan, commented: “This is an extraordinary milestone for Imricor.
“Since founding the Company 17 years ago, the goal has always been to develop technology that enables complex cardiac arrhythmias like ventricular tachycardia (or VT) to be treated utilising real-time 3D MRI (which we call interventional cardiac magnetic resonance, or iCMR) for guidance. We believe real-time 3D MRI imaging can add tremendous value to VT ablations in terms of effectiveness, time savings, and cost – all in an environment that is free of ionising radiation.
“Imricor continues to do what no one else has ever done before, and virtually everyone in the Company has worked tirelessly to make this extraordinary milestone possible. I want to especially acknowledge the clinical and regulatory teams led by our Director of Clinical Research, Dr. Katherine Lindborg, PhD, and our VP of Regulatory and Quality, Jennifer Weisz.”