Vision-MR Ablation Catheter Receives CE Mark
January 27 2020 - 8:00AM
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
Please visit http://imricor.com/investors/about-imricor/ for
more information about Imricor, Foreign Ownership Restrictions, and
Forward-Looking Statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20200127005173/en/
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
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