Overview

• The Iris Valve, developed by University of California, Irvine engineers with clinicians from Children’s Hospital of Orange County, is designed for toddlers weighing 17 to 22 pounds and expands to adult dimensions as they grow.
• Six-month trials in Yucatan mini pigs demonstrated durable integration in the pulmonary valve annulus and a favorable tissue response.
• Researchers estimate the Iris Valve could eliminate at least one additional surgery for hundreds of children over their lifetimes.
• Funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Heart, Lung, and Blood Institute, the National Science Foundation and the Brett Boyer Foundation has supported preclinical phases and will underwrite the next testing stage.
• Investigators are coordinating with the U.S. Food and Drug Administration to finalize requirements for first-in-human trial approval.