Imricor Medical Systems (ASX: IMR) has commenced the VISABL- AFL (Vision-MR Ablation of Atrial Flutter) global clinical trial supporting US Food and Drug Administration (FDA) approval.
The Vision-MR Ablation Catheter contains patented technology that allows it to be used while the patient is being actively scanned during an interventional Cardiac MRI (iCMR) scan.
As part of the trial, two procedures were performed today at the Cardiovascular Institute of South Paris (ICPS).
“Enrolling the first patients in the VISABL-AFL clinical trial represents a significant step forward for the future of 3D real-time MRI ablations in the iCMR lab,” Dr Laurent Fiorina, the operating Electrophysiologist at ICPS and the site’s Principal Investigator, said.
“Performing procedures with Imricor’s NorthStar 3D Mapping System is a game-changer for this field, and it will have a transformative impact. I look forward to the continued partnership with Imricor.
The VISABL-AFL clinical trial is a prospective, single-arm, multi-centre global investigational study of the safety and efficacy of type I atrial flutter ablation procedures performed with the Vision-MR Ablation Catheter (second generation) and Osypka HAT 500 RF generator and irrigation pump.
The study will include four sites across the United States and Europe. The sample size is 91 patients, with an interim analysis after 76 patients have achieved the seven-day follow-up. The company expects to complete trial enrolment before the end of the year.
“This is a huge milestone for all of us at Imricor. Special thanks to Kate Lindborg, our Senior Director of Clinical Affairs, and her entire team. We are on track with VISABL-AFL to complete enrolment this year, supporting our goal of FDA approval for our platform of technology in the US in 2025,” Imricor’s Chair and CEO, Steve Wedan, said.
