Researchers at the University of California, Irwin, have successfully demonstrated a pre -determinical laboratory test of a replacement heart valve, intended for toddlers and young children with congenital heart defects, an important step towards obtaining approval for human use. The results of his study were recently published Journal of the american Heart Association,

Management of patients with congenital heart disease, which requires surgical pulmonary valve replacement, usually occur between 2 and 10 years of age. To be eligible to the minimum invasive transcatator pulmonary valve process, patients should currently weigh at least 45 pounds. To get minimal invasive treatment for children, they must be quite large so that their veins can adjust the size of a crimped replacement valve. The IRIS valve, designed and developed by the UC Irwin team, can be weighed as 17 to 22 pounds in children and gradually expanded up to an adult diameter as they grow.

Research and development of the iris valve is supported by Unis Kennedy Shriver National Institute of Child Health and Human Development; National Heart, Lung and Blood Institutes; And National Science Foundation.

This funding has enabled benchtop fracture testing, which has demonstrated the valve capacity to reduce for a 3-mile meter diameter for transcatator delivery and has later increased to 20 millimeters without damage, as well as a six-month animal studies are confirmed by the successful device united within the pulmonary valve Nulus.

We are happy to see the iris valve, as we expect in laboratory bench tests and an important measure of the viability of the device, in the form of transplantation in Yukaan mini pigs. This work represents the result of long -term cooperation between our team in UC Irwin and Dr. at the Children’s Hospital, Orange County. Michael Recto has created many years of joint research and development in many years. ,

Parsha Kherdavar, lead author, UC Irwin Professor of Biomedical Engineering

Congenital heart defects affect about 1 percent of children born in the United States and Europe, with more than 1 million cases in the US alone. These conditions often require surgical intervention in life, required to address a tapped pulmonary valve with additional procedures and prevents the correct ventricular failure with children growing.

The iris valve can be transplanted through the patient’s fertile vein through the minimum invasive catheter. The Kheradwar group employed the Origemi folding techniques to compress the device into the 12-French transcatter system, not exceeding 3 millimeters to its diameter. Over time, the valve can be expanded to its full 20 millimeters diameter.

This implantation method, with the ability to start treatment in very young patients, helps reduce the risk of complications from delayed care and reduces the need for several surgery in this weaker population.

“Once the iris is revealed of the valve, it will protect hundreds of children from at least one operation – if not two – during their life,” a traditional pediatric cardiologist in Choc, who is also a clinical professor of pediatrics in UC Irwin. “This will prevent them from passing through surgical pulmonary valve placements, as the iris valve is distributed through a small catheter in the vein and can gradually be diluted to an adult diameter and also provides the facility of future placement of the large transcatator lung valves – which is necessary with more than 20 millimeters.

Kherdavar stated that the next stage of the pregnant test of the iris valve has been funded by the Brett Boir Foundation, which is committed to supporting research in treatment for congenital heart disease.

“We are actively engaged with the American Food and Drug Administration to define and complete the experiments and documents required for the first Human Authority of the IRIS valve,” said Kherdavar. “Our team is first advancing the iris valve through pregnant studies to enable its withdrawal to human use. It is an important step towards providing todlers-who does not currently have any viable minimum invasive treatment until they reach 45-pounds of threshold-with one very important option.

First co-author Nanoma Agavu, a biomedical engineering Ph.D. The UC Irwin candidate said: “The development of the IRIS valve was required by a strong and knowledgeable team that understood the clinical and mechanical design requirements. This achievement was not possible without the cooperation of talented physicians, veterinarians and engineers. With reaching this milestone, we are moving strictly on our development.”

As co-writer of the article joining Kheradvar, Recto and Agwu Journal of the american Heart Association Derryl Chow, recently a UC Irwin Master’s graduate; Gregory Kelly and Tanya Burney, both UC Irwin’s research experts, were also associated with the Berki Laser Institute; UC Irwin’s university laboratory with animal resources a clinical veterinarian Akrita Perminov; And Christopher Alkantara, A Radiology Technician in CHOC.