Imricor starts global trial for US FDA approval

Imricor’s VISABL-AFL global trial starts with two procedures successfully undertaken at French hospital
The NorthStar 3D Mapping system praised as a “game-changer” for cardiac ablation
VISABL-AFL trial to support US FDA approval with full trial enrollment on track to be completed in 2024

Special Report: Imricor’s VISABL-AFL global clinical trial supporting US Food and Drug Administration (FDA) approval has kicked off.

Imricor Medical Systems (ASX:IMR) says two procedures were performed this week at the Cardiovascular Institute of South Paris (ICPS) with head of cardiovascular magnetic resonance at the health facility Professor Jerome Garot reporting positive feedback.

“We did the first two cases of RF flutter ablation with the Imricor system, and it went quite smoothly,” Garot says. “We are very enthusiastic about it.”

The VISABL-AFL, which stands for Vision-MR Ablation of Atrial Flutter, 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 IMR’s Vision-MR Ablation Catheter (second generation) and Osypka HAT 500 RF generator and irrigation pump.

The study will include four sites across the US and Europe with a sample size of 91 patients and an interim analysis after 76 patients have achieved the 7-day follow-up.

Improving cardiac ablation

Imricor is looking to transform how cardiac ablation procedures are done to make them safer, faster, improve success rates and be more cost effective.

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 under X-ray guidance, known as X-ray fluoroscopy.

While X-ray is good at showing hard structures like ribs and the catheter itself, it can’t visualise soft tissue like the heart, making it difficult for physicians to know they’ve done the ablation completely in the area which is 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.

IMR is succeeding in the long desire of clinicians to do cardiac ablations under the superior imaging capabilities of magnetic resonance imaging (MRI).

Protected by more than 70 patents, IMR’s equipment looks and feels the same as what physicians currently use for the procedure but are safe and effective for use inside the strong magnetic fields created by an MRI scanner.

‘Game-changer for this field’

ICPS operating electrophysiologist and the site’s principal investigator Dr Laurent Fiorina says 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 interventional cardiac magnetic resonance (iCMR) lab.

“Performing procedures with Imricor’s NorthStar 3D Mapping System is a game-changer for this field, and it will have a transformative impact,” Fiorina says.

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.

IMR Chair and CEO Steve Wedan says IMR expects to complete the VISABL-AFL trial enrollment before the end of 2024.

“This is a huge milestone for all of us at Imricor,” he says. “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.”

Croatian hospital undertakes first iCMR-guided atrial flutter ablation

Earlier this week, IMR announced that the Dubrava University Hospital in Zagreb, Croatia, had performed their first iCMR guided atrial flutter ablation procedure using IMR’s products.

Additional procedures are being scheduled on a regular basis, as the site meets their growing demand for ablations.

Wedan says the company is focused on activating more existing sites, signing new sites and building sales momentum with Dubrava helping to build sales momentum.

“Dubrava is a very busy site with high volume and a limited number of conventional electrophysiology (EP) labs, so they are relying on performing iCMR procedures with our products to effectively add a new EP lab to their practice, Wedan says.

“The hospital is targeting significantly more total ablation procedures this year compared to last year, and physicians are planning to ramp up atrial flutter ablations in the iCMR lab to help meet that demand.”

2024 is proving to be a big year for IMR, with the company also due to start a pivotal European ventricular tachycardia (VT) trial VISABL-VT.

The VISABL-VT trial will have global implications for the company, even before completion of the trial.

The company says the medical community says that MRI guidance would add maximum value to complex ablation procedures, like VT, which require the doctor to access the left side of the heart via puncturing through the septum.

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.