Innovative Growth-Compatible Heart Valve Shows Promise in Preclinical Trials for Young Children

Researchers at the University of California, Irvine have achieved a significant milestone in pediatric cardiology by testing a new heart valve designed explicitly for young children with congenital heart defects. This breakthrough involves the development of the Iris Valve, a transcatheter, growth-accommodating pulmonary valve that has successfully undergone preclinical laboratory evaluations. The findings, recently published in the Journal of the American Heart Association, highlight the valve's potential to revolutionize treatment for toddlers and infants requiring pulmonary valve replacement.

Traditionally, management of congenital heart disease in children involves surgical interventions that often necessitate multiple procedures over the years. Currently, minimally invasive transcatheter procedures requiring patients to weigh at least 45 pounds limit earlier treatment options for smaller children. The Iris Valve addresses this challenge by being suitable for children as light as 17 to 22 pounds, with the ability to gradually expand to match the child's growth up to an adult diameter.

The valve has demonstrated impressive durability in benchtop fracture tests, showing it can be crimped down to a mere 3 millimeters for catheter delivery and then expanded back to 20 millimeters without damage. Animal studies over six months further confirmed the device's effective integration into the pulmonary valve area, maintaining valve integrity and eliciting a favorable tissue response.

Designed with origami folding techniques, the Iris Valve can be implanted via a minimally invasive catheter through the femoral vein. This method reduces surgical trauma, enables earlier intervention, and minimizes complications associated with delayed treatments. The ability to begin treatment in very young patients helps mitigate long-term risks, including right ventricular failure and valve leaks.

Lead researcher Dr. Arash Kheradvar expressed optimism about the valve's performance, emphasizing its potential to eliminate multiple future surgeries for affected children. The team at UC Irvine is working closely with the FDA to perform the additional testing required for first-in-human approval. The goal is to provide an innovative, less invasive treatment option for toddlers who currently lack suitable minimally invasive therapies.

This advancement holds promise for the over one million children affected by congenital heart defects in the U.S. alone. As the Iris Valve progresses into clinical trials, it may transform pediatric cardiac care by offering early, effective, and growth-compatible treatment to the most vulnerable patients, ultimately improving their quality of life and long-term health outcomes.