Imricor Medical Systems (ASX: IMR) has launched its US commercial operations with deployment of the NorthStar interventional magnetic resonance (iMR) cardiac mapping and guidance system at Rady Children’s Hospital in San Diego.
The contract follows US Food and Drug Administration (FDA) safety clearance of NorthStar and Imricor’s Vision-MR diagnostic catheter, which allows doctors to perform real-time electrophysiological mapping and cardiac ablations inside a magentic resonance imaging (MRI) machine.
The FDA also recently cleared paediatric label expansions for both products, enabling their use in patients of any age and opening the door to more than 250 children’s hospitals and 2,000 adult hospitals across the US.
Home to one of the nation’s leading paediatric cardiology programs, Rady will become the first US hospital to commit to delivering cardiac catheterisation procedures guided by NorthStar in a totally radiation-free iMR setting.
The hospital plans to eventually expand its cardiology program to incorporate radiation-free electrophysiology and ablation procedures.
Cardiovascular Vertical Launch
Imricor has announced the launch of vertical offering Imricor Cardiovascular, which harnesses the power of magnetic resonance to help physicians perform cardiac catheterisation procedures under real-time MR guidance using NorthStar.
MR guidance eliminates exposure to ionising x-ray radiation for younger patients while providing superior soft tissue visualisation and richer functional data (such as blood flow or cardiac output) than conventional x-ray fluoroscopy.
The product opens a new market for the company alongside its electrophysiology business and it expects to continue adding devices and applications within the cardiovascular business over the long-term.
Imricor’s commercial momentum is building beyond San Diego with additional US hospitals expected to purchase NorthStar over the coming weeks.
The company is scaling its sales team to service the growing market, adding a US capital sales manager for the southeast region and expects to hire additional sales representatives and internal sales staff over the coming months.
Profound Paediatric Benefits
Rady interventional cardiologist Dr Brent Gordon believes Imricor’s technology would greatly benefit children born with congenital heart defects who may require repeated catheterisations across their lifetime.
“These procedures have historically been guided by x-ray fluoroscopy, which exposes children to ionising radiation at a time when they are growing and are particularly susceptible to radiation exposure,” he said.
“MR guidance eliminates exposure to ionising radiation for patients and staff, while providing improved soft tissue differentiation and functional information that fluoroscopy cannot offer.”
“We are proud that Rady is the first paediatric centre in the world to bring this new technology to our patients.”