14 August 2024 – Minneapolis, 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 first real-time iCMR-guided cardiac ablation procedure has been performed in the United States to support the Vision-MR Ablation Catheter 2.0 for Treatment of Type I Atrial Flutter (VISABL-AFL) IDE clinical trial at the Johns Hopkins Hospital in Baltimore (https://www.hopkinsmedicine.org/).
Dr. Aravindan Kolandaivelu, the operating Electrophysiologist at Johns Hopkins Hospital and the site’s Principal Investigator commented: “Current ablation procedures are limited at detecting heart muscle characteristics that lead to arrhythmia and at determining whether adequate treatment has been delivered to arrhythmia causing areas of the heart. MRI is the gold standard for imaging arrhythmia causing heart characteristics, like fibrosis, and for visualizing the effects of ablation. We are enthusiastic to be a part of the FDA approval study for the Imricor ablation system, which permits seamless integration of MRI information into ablation procedures toward the goal of improving outcomes for difficult to manage arrhythmias, like ventricular tachycardia.”
The VISABL-AFL (NCT05904548) clinical investigation is a prospective, single-arm, multi-center, interventional, Investigational Device Exemption (IDE) trial. The primary objectives of VISABL-AFL are to assess the safety and efficacy of radiofrequency (RF) ablation of type-I atrial flutter performed with the Vision-MR Ablation Catheter 2.0 in the iCMR environment. The sample size is 91 patients, with an interim analysis after 76 patients have achieved the 7-day follow-up. The study includes four hospitals in the U.S. and Europe.
Imricor’s Senior Director of Clinical, Kate Lindborg, commented: “The dedication and commitment from the entire team at Johns Hopkins has been vital to the success of bringing iCMR cardiac ablations to the U.S. Today’s achievement is a testament to Imricor’s and Johns Hopkins’ commitment to improving patient outcomes and enhancing the quality of care for the patients. All of us at Imricor are incredibly proud of this achievement and look forward to the continued partnership with Johns Hopkins.”