Innovative Expandable Heart Valve Offers New Hope for Young Patients

Researchers at the University of California, Irvine (UCI) have made significant strides in pediatric cardiology with the development of a novel expandable heart valve, specifically designed for toddlers and young children suffering from congenital heart defects. This breakthrough, which has successfully completed preclinical laboratory testing, marks a crucial step towards potential human trials, providing hope for a demographic that has been historically underserved by current medical technologies.

The Iris Valve, as it is named, addresses a critical gap in treatment for children who typically require surgical pulmonary valve replacement between the ages of 2 and 10. Traditionally, the minimally invasive transcatheter pulmonary valve procedure mandates that patients weigh at least 45 pounds. However, the Iris Valve can be implanted in children weighing as little as 17 to 22 pounds, allowing for earlier intervention and minimizing the risks associated with delayed treatment.

According to Dr. Arash Kheradvar, a professor of biomedical engineering at UC Irvine and the lead author of the study published in the *Journal of the American Heart Association* on June 23, 2025, "We are pleased to see the Iris Valve performing as we expected in laboratory bench tests and as implants in Yucatan mini pigs, a crucial measure of the device's feasibility." The Iris Valve can be crimped down to a diameter of 3 millimeters for transcatheter delivery and subsequently expanded to 20 millimeters, accommodating the growth of the child.

The research and development of the Iris Valve received substantial support from reputable organizations, including the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Heart, Lung, and Blood Institute, and the National Science Foundation. These institutions funded critical testing, demonstrating the valve's ability to integrate successfully within the pulmonary valve annulus and maintain structural integrity over time.

Dr. Michael Recto, an interventional pediatric cardiologist at Children’s Hospital of Orange County (CHOC) and a clinical professor at UC Irvine, emphasized the potential impact of the Iris Valve on pediatric patients, stating, "Once the Iris Valve comes to fruition, it will save hundreds of children at least one operation – if not two – throughout the course of their lives." This technique represents a significant advancement in the field, facilitating subsequent placements of larger transcatheter pulmonary valves if necessary.

Congenital heart defects affect approximately 1% of children born in the United States and Europe, translating to over one million cases in the U.S. alone. These conditions often necessitate multiple surgical interventions, which can pose significant risks. The innovative design of the Iris Valve, utilizing origami folding techniques, allows for a minimally invasive implantation via the femoral vein, reducing the need for open-heart surgery and associated complications.

The next phase of preclinical testing for the Iris Valve is being funded by the Brett Boyer Foundation, an organization dedicated to improving outcomes for children with congenital heart disease. Dr. Kheradvar noted, "We are actively engaged with the U.S. Food and Drug Administration to define and carry out the required experiments and documentation for first-in-human authorization of the Iris Valve." This collaboration is critical as it aims to expedite the process of bringing this life-saving device to clinical use.

As the UCI team continues to advance the Iris Valve through preclinical studies, the future looks promising for young patients who currently face limited options for treatment. The ability to administer care at an earlier age may significantly improve their quality of life and reduce the overall burden of congenital heart disease across pediatric populations.

The collaborative efforts of clinicians, engineers, and researchers underline the importance of interdisciplinary approaches in developing innovative medical solutions. With the Iris Valve, there is hope not only for improved surgical outcomes but also for the enhancement of life for countless children affected by congenital heart defects.