05 August 2021 – Minneapolis, United States – Imricor Medical Systems, Inc. (Company or Imricor) (ASX:IMR) the global leader in MRI-guided cardiac ablation products, has achieved an important milestone in its geographic expansion plans with the Company’s Advantage-MR EP Recorder/Stimulator system receiving Australian TGA approval.
Approval of this system was expected before the end of 2021, and the TGA’s review of the Company’s Vision-MR Ablation Catheter is also now underway.
In New Zealand, all Imricor products have been approved by Medsafe and are registered in the WAND database for medical devices.
Imricor’s Chair and CEO, Steve Wedan, said: “This is a great milestone in our strategy of geographical expansion.
“We are working closely with our distributor in the region, Regional Health Care Group, to plan the in-depth training and certification of their staff on our products, procedures, technology, installation, clinical training, and clinical support
We look forward to bringing MRI-guided cardiac ablations to patients and physicians in Australia and New Zealand.
“It is particularly exciting that the potential now exists for a few select Australian and/or New Zealand sites to participate in our worldwide ventricular tachycardia ablation clinical trial slated for 2022.”
Entering into the Australian and New Zealand markets is a part of Imricor’s multi-country expansion plan to bring MRI-guided cardiac ablations worldwide.