Imricor Medical Systems Ltd (ASX:IMR) has launched its US commercial operations after securing Rady Children’s Hospital–San Diego as the first American hospital to purchase its NorthStar® interventional magnetic resonance mapping and guidance system.
The agreement follows US Food and Drug Administration 510(k) clearances for NorthStar and the Vision-MR® Diagnostic Catheter, as well as subsequent pediatric label expansions permitting both products to be used in patients of all ages.
Rady Children’s plans to establish a NorthStar-guided cardiac catheterisation program in a completely radiation-free interventional magnetic resonance, or iMR, environment.
The hospital also intends to expand the program into radiation-free diagnostic electrophysiology and cardiac ablation procedures.
US commercial launch gathers momentum
Rady Children’s is home to a leading pediatric cardiology program and will become the first US hospital to commercially deliver cardiac catheterisation procedures using NorthStar in an iMR setting.
Several other US hospitals are reportedly in the final stages of the purchasing process, with additional NorthStar sales expected over the coming weeks.
Imricor said revenue from these initial NorthStar sales was expected to exceed the total revenue generated by its European business during 2025.
The company is expanding its US commercial team in response, including the appointment of an additional capital sales manager for the southeast region and further planned hires across sales and internal operations.
New cardiovascular market opens
The launch also marks the establishment of Imricor Cardiovascular, a new business vertical focused on using real-time MR guidance during cardiac catheterisation procedures.
The platform gives Imricor access to a market comprising more than 250 children’s hospitals and over 2,000 adult hospitals performing cardiac catheterisation procedures across the United States.
For paediatric patients, particularly children with congenital heart disease who may require repeated procedures, MR guidance removes exposure to ionising X-ray radiation while offering improved soft-tissue imaging and functional information such as blood flow and cardiac output.
Rady Children’s interventional cardiologist Dr Brent Gordon said the technology could materially change the treatment pathway for children who require repeated catheterisations.
“MR guidance eliminates exposure to ionising radiation for both patients and staff, while providing us with improved soft tissue differentiation and functional information that fluoroscopy can’t provide,” he said.
“We’re proud that Rady Children’s Health is the first pediatric center in the world to bring this new technology to our patients.”
Hospital efficiency benefits
The technology also presents a compelling economic case for hospitals.
Conventional treatment may require a patient to undergo an MRI scan and a separate X-ray-guided catheterisation on different days, involving separate clinical teams.
An iMR workflow combines these steps into a single session, delivering estimated procedural time savings of around 35% per patient and reducing operational costs.
Moving routine catheterisation procedures into an iMR lab may also free up X-ray cath lab capacity for other interventional procedures, potentially supporting additional hospital revenue.
About Imricor
Imricor develops MR-compatible systems and devices designed to allow interventional medical procedures to be performed under real-time magnetic resonance guidance rather than X-ray fluoroscopy.
Its product portfolio includes the NorthStar Mapping System, Advantage-MR® EP Recorder/Stimulator and a range of single-use diagnostic and ablation devices, catheters and steerable sheaths.
Imricor’s products are approved in the European Union, Saudi Arabia and New Zealand, while NorthStar is cleared for use in the United States.