Promising Early-Stage Preclinical Results for Innovative Heart Valve Developed at UC Irvine

Irvine, Calif., June 23, 2025 — Researchers at the University of California, Irvine, have made significant strides in the field of pediatric cardiology with the preclinical testing of a groundbreaking heart valve replacement, specifically designed for toddlers and young children suffering from congenital cardiac defects. This development, which holds the potential to transform the lives of countless children, marks a pivotal moment in the quest for safer, less invasive surgical alternatives for managing congenital heart disease. The findings from this study have been recently published in the esteemed Journal of the American Heart Association, adding to the growing body of research surrounding advanced cardiac treatments for vulnerable pediatric populations.

Congenital heart defects, which are structural issues with the heart present at birth, impact approximately one percent of all children born in the United States and Europe. In the United States alone, over a million children are living with these conditions. Many of these young patients require surgical interventions early in life, particularly for procedures involving the pulmonary valve, which can become necessary as they grow and face complications such as valve leakage. Traditionally, surgical pulmonary valve replacements are performed between the ages of 2 and 10, necessitating that children meet specific weight requirements to qualify for minimally invasive treatment options.

Currently, the standard for eligibility to undergo a minimally invasive transcatheter pulmonary valve procedure necessitates that children weigh at least 45 pounds. This requirement often excludes the smallest and youngest patients, leaving a critical gap in treatment options. However, the innovative design of the Iris Valve, conceived and developed by the research team at UC Irvine, drastically shifts this paradigm. This device can be implanted in children weighing as little as 17 to 22 pounds and can be gradually expanded as the child grows, accommodating their developmental needs while reducing the need for multiple surgical interventions.

.adsslot_e5sD7QdliR{width:728px !important;height:90px !important;}
@media(max-width:1199px){ .adsslot_e5sD7QdliR{width:468px !important;height:60px !important;}
}
@media(max-width:767px){ .adsslot_e5sD7QdliR{width:320px !important;height:50px !important;}
}

ADVERTISEMENT

The Iris Valve has undergone rigorous testing supported by prestigious bodies such as the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Heart, Lung, and Blood Institute, and the National Science Foundation. This backing has enabled essential benchtop testing to demonstrate the valve’s ability to be crimped down to a mere 3-millimeter diameter for transcatheter delivery. Remarkably, it can then be balloon-expanded to a full 20-millimeter diameter, providing the necessary flexibility and functionality for growing children’s hearts.

In-depth studies performed on Yucatan mini pigs have unveiled promising results, confirming successful integration of the valve within the pulmonary valve annulus. Not only did these studies demonstrate the resilience of the valve, but they also indicated a favorable tissue response, suggesting that the Iris Valve can effectively support a child’s health as they undergo the natural process of growth. Lead author Arash Kheradvar, a professor of biomedical engineering at UC Irvine and a driving force behind the Iris Valve project, expressed his enthusiasm regarding these laboratory tests and the collaboration they entailed, highlighting the years of joint research with pediatric specialists to bring this innovation to fruition.

The minimally invasive implantation approach for the Iris Valve involves a catheter delivered through the femoral vein, utilizing advanced origami folding techniques to compress the device for transcatheter delivery. This process not only facilitates safer procedures but also helps mitigate risks associated with delayed treatment, addressing a critical need for early intervention in affected children. By introducing this advanced technology into the pediatric cardiology landscape, healthcare providers hope to decrease the necessity for multiple invasive surgeries, thus improving overall outcomes for young patients at risk of severe cardiac complications.

The implications of the Iris Valve extend beyond immediate surgical relief; it has the potential to save countless children from the necessity of at least one, if not two, additional surgeries throughout their lives. This advancement is particularly significant as it paves the way for future interventions as children continue to grow. The Iris Valve could allow for the eventual placement of larger transcatheter pulmonary valves if required, ensuring that children always have access to suitable treatment options as their anatomical and physiological needs evolve.

As the research moves forward, the next phase of preclinical testing is being funded by the Brett Boyer Foundation, an organization dedicated to advancing research into congenital heart disease treatments. This support is instrumental in the continued development of the Iris Valve, as the research team collaborates with the U.S. Food and Drug Administration to determine the necessary experiments and documentation for first-in-human trials. The urgency of this work cannot be understated, as it reflects a concerted effort to bridge the treatment gap for young children who currently have no viable minimally invasive options until they reach the requisite weight for existing procedures.

The development of the Iris Valve exemplifies the amalgamation of clinical acumen, mechanical design, and engineering expertise, underscoring the importance of interdisciplinary teams in advancing medical technology. First co-author Nnaoma Agwu, a Ph.D. candidate in biomedical engineering at UC Irvine, noted the critical nature of collaboration in reaching this milestone. With the foundation laid and promising results emerging from preclinical investigations, the focus now shifts toward accelerating the Iris Valve’s path to human clinical trials, bringing renewed hope to families affected by congenital heart disease.

The challenges presented by congenital heart defects are profound, but the introduction of devices like the Iris Valve signals a transformative shift in how these conditions may be treated in future generations. Continued advancements in medical research and technology are essential, not only for the immediate management of cardiac conditions in pediatric patients but also in setting the stage for innovations that could redefine the landscape of heart health care. As the research community remains vigilant and driven, the Iris Valve stands as a beacon of hope for the thousands of families grappling with the complexities of congenital heart disease.

The journey of the Iris Valve is just beginning, with researchers and clinicians united in their pursuit of a safe and effective treatment alternative for young patients in dire need. Anticipation is building as they move closer to initiating human clinical trials, promising to bring forth new possibilities in pediatric cardiology and facilitating a brighter future for children battling congenital heart issues.

Research teams like those at UC Irvine exemplify the critical intersection of science, technology, and compassion, forging pathways toward innovations that can profoundly impact lives. With unwavering dedication to improving pediatric cardiac care, the Iris Valve represents more than just a medical device; it embodies the hope and promise of a healthier future for children worldwide.

Subject of Research: Replacement Heart Valve for Toddlers and Young Children with Congenital Heart Defects
Article Title: Preclinical Evaluation of a Growth‐Accommodating Transcatheter Pulmonary Valve System for Young Children
News Publication Date: June 23, 2025
Web References: https://www.ahajournals.org/doi/full/10.1161/JAHA.125.041932
References: Journal of the American Heart Association
Image Credits: University of California, Irvine

Keywords

Biomedical engineering, congenital heart defects, pulmonary valve replacement, pediatric cardiology, transcatheter valve, minimally invasive surgery.

Tags: congenital cardiac defects in childrenearly-stage cardiac treatment developmentsinnovative heart valve replacementJournal of the American Heart Association publicationmanaging congenital heart diseasepediatric cardiology advancementspediatric heart valve surgerypreclinical testing in cardiologysafer surgical alternatives for heart diseasestructural heart issues in infantsUC Irvine heart researchvalve leakage in young patients