Imricor Medical Systems receives key European certification for Vision-MR diagnostic catheter

Medical device manufacturer Imricor Medical Systems (ASX: IMR) has received CE mark certification to sell its low-cost Vision-MR diagnostic cardiac catheter in Europe.

It is the first Imricor device to be approved under the European Union’s strict new medical device regulations regime.

The Vision-MR diagnostic catheter is designed to work under real-time magnetic resonance imaging guidance and aims to enable higher success rates along with faster and safer treatment compared to conventional procedures using x-ray-guided catheters.

It has been designed to look, feel and function like a traditional ablation catheter and contains patented technology allowing it to be used while a patient is being actively scanned in an iCMR (interventional cardiac magnetic resonance imaging).

Imricor sells its capital and consumable products to hospitals and clinics for use in iCMR labs, where procedures using the Vision-MR ablation catheter can be performed.

Streamlined design

Currently, Imricor customers purchase a two-piece kit of Vision-MR catheters for each trial flutter procedure — one is used for ablating, while the other is used as a diagnostic (reference) tool.

Imricor’s diagnostic catheter is being marketed at a lower cost than the two-piece product and will replace the second ablation catheter in the kit, potentially improving margins for each procedure.

The company estimates the cost to manufacture the Vision-MR diagnostic catheter will be approximately 35% less than for the ablation catheter.

It is expected to realise immediate margin improvements.

Positive validation

Chief executive officer Steve Wedan welcomed the CE mark certification.

“This was a huge effort due to the new medical device regulations in Europe [and] is a positive validation of years of work across all functions, led by our world-class quality and regulatory team,” he said.

“With this certification, the foundation of our quality system has proven itself solid under [the new regulations] and [it] will be leveraged as the rest of our devices subsequently go through the new European regulatory process.”

Manufacturing of the Vision-MR diagnostic catheter will begin next month.