MINNEAPOLIS– (BUSINESS WIRE) – Imricor Medical Systems, Inc. (ASX: IMR) maakt vandaag bekend dat het de CE-keurmerk heeft ontvangen voor zijn Vision-MR Ablatie-katheter en Vision-MR Dispersive Electrode. Dit volgt op eerdere goedkeuring van het CE-keurmerk voor Imricor om zijn Advantage-MR EP Recorder/Stimulator Systemop de markt te brengen in Europa. Imricor is het eerste en enige bedrijf dat cardiale ablatie-apparaten aanbiedt voor gebruik in de MRI-omgeving.

Steve Wedan, voorzitter en CEO van Imricor: “We zijn absoluut verheugd om onze producten op de markt te brengen voor het uitvoeren van hartkatheter ablaties op basis van realtime MRI.

“Ontvangst van CE-keurmerk is een belangrijke prestatie voor het Imricor-team, terwijl we onze missie nastreven om de levens van mensen wereldwijd te verbeteren door apparaten te leveren die iCMR-procedures mogelijk maken.”

Vision-MR Ablation Catheter Receives CE Mark

MINNEAPOLIS–(BUSINESS WIRE)– Imricor Medical Systems, Inc. (ASX:IMR) today announces that it has received CE mark approval for its Vision-MR Ablation Catheter and Vision-MR Dispersive Electrode. This follows earlier CE mark approval for Imricor to place its Advantage-MR EP Recorder/Stimulator System on the market in Europe. Imricor is the first and only company to offer cardiac ablation devices for use in the MRI environment.

Imricor Chairman and CEO, Steve Wedan said, “We are absolutely thrilled to bring to market our products for performing cardiac catheter ablations guided by real-time MRI.

“Receipt of CE mark approval marks a major accomplishment for the Imricor team, as we pursue our mission to improve the lives of people worldwide by delivering devices that enable iCMR procedures.”

The Vision-MR Ablation Catheter is the Company’s prime product offering, specifically designed to work under real-time MRI guidance, with the intent of enabling higher success rates along with a faster and safer treatment compared to conventional procedures using x-ray guided catheters.

“This approval opens the door for patients to benefit from this exclusive combination of therapy and imaging. We are extremely excited to offer this to our patients and to lead the way forward with this new approach,” said Professor Gerhard Hindricks MD, Head of the Department of Electrophysiology at the Leipzig Heart Center.

Imricor sells its capital and consumable products to hospitals and clinics for use in Interventional Cardiac Magnetic Resonance Imaging (iCMR) labs, in which ablation procedures using the Vision-MR Ablation Catheter can be performed.

Wedan stated, “With inventory located in our European warehouse and a well-established roll out plan in place, we will now move swiftly to the execution of a controlled commercial launch to ensure smooth adoption and good clinical outcomes.”

Imricor has entered into agreements with multiple sites regarding the sale of its products. These sites have Advantage-MR systems and are ready to commence procedures having achieved CE mark approval.

Imricor Director of Marketing, Nick Twohy stated, “The future of cardiac ablation therapy is in MR-guidance and this product launch is the first step towards a new standard of care. We look forward to partnering with healthcare professionals to offer a new treatment option for patients who suffer from arrhythmias.”

About Imricor

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Contacts

Investors:
Steve Wedan

Executive Chair, President and CEO

Email: steve.wedan@imricor.com

Carrie Barrack

Senior Advisor, Cato & Clegg

Email: carrie@catoandclegg.com
Phone: +61 422 464 028

Media:
Carrie Barrack

Senior Advisor, Cato & Clive

Email: carrie@catoandclive.com
Mobile: +61 422 464 028