22 September 2022 – 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 that the Company has submitted for approval to commence a real-time iCMR-guided ventricular tachycardia (VT) ablation clinical trial.
The name of the study is “Vision-MR Ablation of VT” or VISABL-VT.
VISABL-VT is a prospective, single-arm, multi-centre interventional investigation of the safety and efficacy of radiofrequency (RF) ablation of ventricular tachycardia 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 6-month follow-up for each patient, as is typical.
The application for approval to commence VISABL-VT was submitted to the Ethics Committee at the Leipzig Heart Centre (the lead clinical site) as well as the German Federal Institute for Drugs and Medical Devices (BfArM), the German Competent Authority. Both submissions took place on September 15th. The Ethics Committee review will happen first, followed by a review by the Competent Authority. Upon approval by both regulating bodies, the trial will commence.
Additional submissions will follow as new sites are added to the study.
Imricor’s Chair and CEO, Steve Wedan, commented: “This is a major milestone for Imricor that brings us one monumental step closer to treating ventricular tachycardia with ablation procedures guided by real-time iCMR.
“Since this is our first clinical trial submission under the new Medical Device Regulations in Europe, we do not have a clear estimate of how long the approval process will take, but we are hopeful that we can begin enrolment before the end of the year.”