Imricor Medical Systems Gains FDA Paediatric Clearances for NorthStar and Diagnostic Catheter

Imricor Medical Systems (ASX: IMR) has received US Food and Drug Administration (FDA) 510(k) clearances to expand the labelling of its NorthStar system and Vision-MR Diagnostic Catheter to include paediatric use.

The approvals allow Imricor to market both products for patients of any age, including children and young adults treated across more than 250 children’s hospitals in the US.

The clearances open potential paediatric applications for interventional magnetic resonance (iMR)-guided procedures such as cardiac catheterisations.

Imricor expects the expanded labels to support its US commercialisation strategy by adding an early paediatric channel ahead of broader adult hospital adoption of its full electrophysiology (EP) platform.

Paediatric Market Opportunity

NorthStar received FDA clearance for adult patients in January, before Imricor submitted a paediatric labelling expansion in April.

The company also submitted the Vision-MR Diagnostic Catheter for paediatric expansion during the FDA review process to create a more complete set of paediatric iMR devices.

Imricor identified children with congenital heart defects who require multiple cardiac catheterisations at a young age as a key patient group that could benefit from radiation-free iMR procedures.

The company believes iMR procedures can eliminate procedure-related X-rays for vulnerable paediatric patients, who are more sensitive to ionising radiation exposure, and is developing magnetic resonance-compatible systems and devices to allow interventional procedures to be performed under real-time MR guidance rather than X-ray fluoroscopy.

Diagnostic right and left heart catheterisations represent a new market opportunity for Imricor, with more than 250,000 procedures performed annually in the US across adult and children’s hospitals.

Early Commercial Pathway

Imricor considers paediatric hospitals a potentially attractive early commercial channel because many have a strong interest in reducing radiation exposure and contrast dye use.

Chief executive officer Steve Wedan said Imricor wanted to deliver its products to all patient segments that could benefit from radiation-free iMR procedures.

“Having experienced first-hand the paediatric use of products I personally developed throughout my career, I can say there is something particularly rewarding about providing technology to help infants and young children,” he said.

“Changing the world of interventional medicine for doctors and patients means changing it for all doctors and all patients.”