The first US patient has been treated in Imricor’s VISABL-AFL trial. Pic: Getty Images.
Health & Biotech
Special Report: The first real-time iCMR-guided cardiac ablation in the US has been performed at The Johns Hopkins Hospital in Baltimore as part of Imricor Medical Systems’ pivotal clinical trial supporting US Food and Drug Administration (FDA) approval of its products.
Imricor Medical Systems (ASX:IMR) says Johns Hopkins is the second hospital to join its Vision-MR Ablation of Atrial Flutter (VISABL-AFL) clinical trial, which is looking to make the procedure safer, faster, improve success rates and be more cost effective.
VISABL-AFL is a prospective, single-arm, multi-centre global investigational trial examining the safety and efficacy of type I atrial flutter ablation procedures performed with IMR’s Vision-MR Ablation Catheter (second generation) and Osypka HAT 500 RF generator and irrigation pump.
IMR says the VISABL-AFL trial for FDA approval is a repeat of the trial the company already did in Europe for CE Mark approval which showed 100% success at the 3 month follow up.
The trial for FDA approval requires 91 patients to be treated with an early exit at 76 if the company meets the safety and efficacy end point of 80% success after a 7 day follow up.
Johns Hopkins joins the trial following the Cardiovascular Institute of South Paris (ICPS) in June.
In July IMR announced that installation of interventional cardiac magnetic resonance Imaging (iCMR) capital equipment at the world-renowned Lausanne University Hospital (CHUV) in Switzerland, is complete.
First patient enrolment at CHUV for VISABL-AFL is expected in August, following clinical trial start-up activities, which include the installation of IMR’s NorthStar 3D Mapping System and on-site training performed by Imricor clinical personnel.
IMR’s NorthStar 3D Mapping System is the only MRI compatible 3D mapping system of the heart globally and an important part of its portfolio with collaborations underway with Siemens, Philipps and GE Healthcare to integrate with their respective MRI platforms.
A catheter ablation is performed by an electrophysiologist to address arrhythmia, who will make an incision in the patient’s groin and guide a catheter through the vein up to the heart.
The procedure is currently done using X-ray guidance, known as X-ray fluoroscopy, but IMR is succeeding in the long desire of clinicians to do cardiac ablations under the superior imaging capabilities of magnetic resonance imaging (MRI).
While X-ray is good at showing hard structures such as ribs and the catheter itself, it can’t visualise soft tissue, such as the heart, making it difficult for physicians to know they’ve done the ablation completely in the area causing the arrhythmia.
The long-term first-time success rates of cardiac ablation can be as low as 50% with patients often requiring 2-3 procedures to permanently fix the arrhythmia with X-ray fluoroscopy also exposing patients and medical staff to radiation throughout the procedure.
Protected by more than 90 patents, IMR’s equipment looks and feels the same as the ones physicians currently use for the procedure but are uniquely safe and effective for use inside the strong magnetic fields created by an MRI scanner.
IMR says the goal of undertaking complex cardiac ablation procedures under an MRI is to make them safer, faster, more successful and cost effective.
IMR chair and CEO Steve Wedan says the company is on track for mid-2025 approval by the FDA.
“We are fortunate to work with some of the highest-calibre doctors and medical teams across Europe, and to have such an esteemed institution like Johns Hopkins be the first US hospital to use the technology is a real privilege.”
“We are on track to complete enrolment in VISABL-AFL this calendar year, and we hope to have FDA approval by mid-2025, thereby making real-time iCMR ablations available to patients and physicians throughout the United States.”
This article was developed in collaboration with Imricor Medical Systems, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
Health & Biotech
Health & Biotech
Health & Biotech
