Imricor wins European assent for its world-leading heart tool

Imricor receives CE Mark certification for the Advantage-MR system under new European Medical Device Regulation as it hits world first with start of VISABL-VT trial.

• Imricor receives CE Mark certification for the Advantage-MR system under new European Medical Device Regulation

• Approval follows CE Mark certification for the second-generation Vision-MR Ablation Catheter in February

• Imricor recently started its European clinical trial known as VISABL-VT, achieving several world firsts 

 

Special Report: Imricor Medical Systems has secured CE Mark certification for its Advantage-MR system under the European Union's new Medical Device Regulation (MDR), just one week after launching its European clinical trial – marking a series of world-first milestones.

The approval follows CE Mark certification under the new MDR in February for the Imricor Medical Systems (ASX:IMR) second generation Vision-MR Ablation Catheter.

Commercial launch of the second-generation Vision-MR Ablation Catheter and the new Advantage-MR system is planned to start in June across new and existing sites in the EU.

Imricor is pioneering real-time interventional cardiac MRI (iCMR) ablations – using MRI instead of traditional x-ray fluoroscopy to treat cardiac arrhythmias faster, safer and more effectively.

It’s the only company globally offering MRI-compatible consumables, like single-use ablation catheters, essential for iCMR procedures.

The key advantage lies in MRI’s superior ability to visualise the heart and blood vessels, which are often hard to see with x-ray.

Imricor’s second-generation Vision-MR Ablation Catheter incorporates performance and cost improvements developed by the company’s engineers over the past decade and is designed to be its future ablation catheter globally.

The company’s Advantage-MR system is the capital equipment that Imricor sells when it establishes a new iCMR lab and is what the catheters plug into generating the ongoing consumable revenue attached to every procedure.

Imricor achieves world firsts with start of VISABL-VT trial

The second-generation Vision-MR Ablation Catheter is also involved in Imricor’s pivotal European trial for ventricular tachycardia (VISABL-VT), which has now started and achieved some world firsts.

The company announced last week it had successfully completed the first-in-human ventricular ablation guided by real-time iCMR with the company’s NorthStar Mapping System.

Imricor said the procedure at Amsterdam University Medical Centre (UMC) marked several world firsts.

It was the first ventricular ablation to be guided by real-time MRI, and it was the first left-sided ablation to be performed under real-time MRI guidance. The patient was treated for right-sided and left-sided premature ventricular complexes (PVCs).

“The patient is doing well; the procedure went according to plan and the arrhythmia has been eliminated,” said Cor Allaart, Professor of Electrophysiology and cardiologist at Amsterdam UMC. 

“We are therefore extremely proud that with our years of preparation, we have now reached the point where we are the first in the world to be able to treat complex forms of cardiac arrhythmias in an MRI scanner.”

Completion of the procedure represents start of VISABL-VT where 64 patients will be recruited over the next 12 months, with the goal of achieving approval for the indication of ventricular tachycardia (VT).

It’s been a big start to 2025 for Imricor, which also recently completed a successful $70 million capital raising.

The company is also undertaking its Vision-MR Ablation of Atrial Flutter (VISABL-AFL) pivotal clinical trial supporting US Food and Drug Administration (FDA) approval of its products for the indication, which it hopes to achieve in 2025.

Imricor’s full product portfolio now MDR-approved

Imricor’s chair and CEO Steve Wedan said the company’s entire commercial product portfolio in Europe was now approved under MDR.

“This was a huge undertaking over the past several years to transition from the old European medical device directive rules to the new, more stringent medical device regulations,” he said.

He noted the company’s Vice President of regulatory and quality Jennifer Weisz had built a world-class team, which continued to deliver approvals for multiple products across multiple geographies, all with varying regulations and requirements.

“During this regulatory transition, we also took the opportunity to significantly improve our Vision-MR Ablation Catheter, and early feedback from physicians who have used the new second generation catheter in our VISABL-AFL and VISABL-VT clinical trials has been very positive, noting improved manoeuvrability characteristics and robustness,” he said.

“We will soon commence phasing out the first-generation products from the market, replacing them with these new MDR CE mark approved devices.”

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

Originally published as Imricor wins European assent for its world-leading heart tool