Imricor Launches US Commercial Operations with First NorthStar Radiation-Free Cardiac System at Rady Children's Hospital
核心洞察
Imricor Medical Systems (搜索) has launched US commercial operations with Rady Children's Hospital–San Diego (搜索) as its first American customer for the NorthStar iMR mapping and guidance system.
The FDA-cleared NorthStar system and Vision-MR catheter enable completely radiation-free cardiac catheterization under real-time MRI guidance, with pediatric label expansions for patients of all ages.
MR guidance eliminates ionizing radiation exposure while providing superior soft-tissue imaging and functional data compared to conventional X-ray fluoroscopy.
Imricor Medical Systems (搜索) Ltd (ASX:IMR) has officially launched its US commercial operations, securing Rady Children's Hospital–San Diego (搜索) as the first American hospital to purchase its NorthStar® interventional magnetic resonance (iMR) mapping and guidance system. The agreement follows US Food and Drug Administration 510(k) clearances for both NorthStar and the Vision-MR® Diagnostic Catheter, along with subsequent pediatric label expansions that now permit use of both products in patients of all ages.
Rady Children's, home to one of the nation's leading pediatric cardiology programs, plans to establish a NorthStar-guided cardiac catheterization program in a completely radiation-free iMR environment. The hospital also intends to expand the program into radiation-free diagnostic electrophysiology and cardiac ablation procedures.
A New Standard in Radiation-Free Cardiac Care
The NorthStar system represents a fundamental shift in how cardiac catheterization procedures are performed. Rather than relying on conventional X-ray fluoroscopy, the technology enables real-time MR guidance, eliminating exposure to ionizing radiation for both patients and clinical staff while providing superior soft-tissue differentiation and richer functional data—including blood flow and cardiac output measurements—that fluoroscopy cannot offer.
Dr. Brent Gordon, interventional cardiologist at Rady Children's, emphasized the clinical significance for younger patients. "These procedures have historically been guided by x-ray fluoroscopy, which exposes children to ionizing radiation at a time when they are growing and are particularly susceptible to radiation exposure," he said. "MR guidance eliminates exposure to ionizing radiation for patients and staff, while providing improved soft tissue differentiation and functional information that fluoroscopy cannot offer."
Dr. Gordon added: "We're proud that Rady Children's Health is the first pediatric center in the world to bring this new technology to our patients."
Imricor Cardiovascular: A New Business Vertical
The US launch also marks the establishment of Imricor Cardiovascular, a new business vertical focused on using real-time MR guidance during cardiac catheterization procedures. This platform gives Imricor access to a market comprising more than 250 children's hospitals and over 2,000 adult hospitals performing cardiac catheterization procedures across the United States.
The technology holds particular promise for pediatric patients with congenital heart disease (搜索) who may require repeated catheterizations over their lifetime, a population for whom cumulative radiation exposure is a significant clinical concern.
Hospital Efficiency and Economic Benefits
Beyond clinical advantages, the iMR workflow presents a compelling economic case for hospitals. Conventional treatment pathways may require a patient to undergo an MRI scan and a separate X-ray-guided catheterization on different days, involving separate clinical teams. The NorthStar iMR workflow combines these steps into a single session, delivering estimated procedural time savings of approximately 35% per patient and reducing operational costs.
Additionally, moving routine catheterization procedures into an iMR lab may free up X-ray cath lab capacity for other interventional procedures, potentially supporting additional hospital revenue.
Commercial Momentum and Team Expansion
Imricor reports that several other US hospitals are in the final stages of the purchasing process, with additional NorthStar sales expected over the coming weeks. The company stated that revenue from these initial NorthStar sales is expected to exceed the total revenue generated by its European business during 2025.
In response to growing demand, Imricor is expanding its US commercial team, including the appointment of an additional capital sales manager for the southeast region and further planned hires across sales and internal operations.
Imricor's broader product portfolio includes the Advantage-MR® EP Recorder/Stimulator and a range of single-use diagnostic and ablation devices, catheters, and steerable sheaths. The company's products are approved in the European Union, Saudi Arabia, and New Zealand, while NorthStar is now cleared for use in the United States.