• Imricor’s second-generation Vision-MR Ablation Catheter receives CE mark certification under new European Medical Device Regulation
• The catheter is involved in Imricor’s pivotal trials – VISABL-VT in Europe and VISABL-AFL in the US
• Imricor expects to submit new MDR-compliant second-generation Vision-MR Ablation Catheter for TGA approval in Australia

Special Report: Imricor Medical Systems has achieved a key milestone with its second–generation Vision-MR Ablation Catheter receiving CE mark certification under the new, more stringent European Medical Device Regulation (MDR) for the treatment of type 1 atrial flutter (AF).

Imricor Medical Systems’ (ASX:IMR) second-generation Vision-MR Ablation Catheter is the device involved in the company’s pivotal VISABL-AFL clinical trial supporting US Food and Drug Administration (FDA) approval to treat atrial flutter.

The second-generation Vision-MR Ablation Catheter is also involved in Imricor’s pivotal European trial for ventricular tachycardia (VISABL-VT).

Ventricular tachycardia is the next indication on which the technology is focused, and it’s also where the company believes there will be the largest unmet need.

Imricor said it had received the final approval certificate to enable manufacturing of the second-generation Vision-MR Ablation Catheter under MDR following an on-site audit conducted by Imricor’s Notified Body in October 2024.

The MDR is a set of stringent regulations that governs production and distribution of medical devices in Europe.

With the successful CE mark certification under MDR, Imricor said it expected to submit the catheter for approval by the Australian Therapeutic Goods Administration (TGA).

Leader in cardiac ablations under MRI

Imricor is developing technology for real-time interventional cardiac magnetic resonance (iCMR) ablations.

Essentially this means cardiac ablations guided by real-time magnetic resonance imaging (MRI), rather than by conventional x-ray fluoroscopy, with the goal to provide faster, safer and more effective treatments of cardiac arrhythmias compared to conventional means.

Imricor is the only company in the world that provides MRI-compatible consumable devices, such as single-use ablation catheters, required to perform cardiac ablations in an iCMR lab.

Benefits of real-time iCMR cardiac ablations are derived from the superior imaging capabilities of MRI compared to x-ray, especially when it comes to imaging the heart and vascular structures, which are largely invisible to x-rays.

‘Very positive sign’

Imricor’s chair and CEO Steve Wedan said the 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.

“Achieving CE mark under the more challenging MDR regime for our flagship consumable device, the 2nd Generation Ablation Catheter, is a very positive sign that speaks volumes about the quality and robustness of our design, manufacturing, quality system and regulatory team,” he said.

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.