CAMBRIDGE, MA—Children with defective heart valves often have no alternative but to undergo multiple open heart surgeries before becoming adults. The reason: there are no heart valve prosthetics designed to grow with a child.
To address this critical unmet need, the Department of Defense has awarded Draper, Boston Children’s Hospital and Seattle Children’s Research Institute a $4.3 million, three-year grant to explore the feasibility of treating congenital heart defects in children using a growth-adaptive pediatric heart valve.
The device is among the first heart valves designed specifically for infants and young children that will grow with them. It will cover valve sizes not currently available on the market: most adult heart valve prosthetics have fixed diameters of 18 mm or larger, which do not fit infants and toddlers. The growth-adaptive pediatric heart valve will double in diameter while maintaining its function, eliminating one or more open heart surgeries or other invasive procedures that a child with a congenital heart defect would otherwise undergo during childhood.
Funding will be provided by the Department of Defense’s U.S. Army Medical Research Acquisition Activity. The multicenter study will evaluate the efficacy and safety of the growth-adaptive pediatric heart valve in a growing animal model. The goal is to develop the heart valve to the investigational device exemption stage, positioning it for first-in-human early feasibility studies. Ultimately, the plan is to apply for FDA approval through the agency’s Humanitarian Device Exemption pathway.
“Children born with congenital heart valve defects number in the thousands each year, yet there are no artificial cardiac valves available that were designed specifically for babies,” said Dr. Sitaram Emani, a pediatric surgeon and the director of Complex Biventricular Repair Program at Boston Children’s Hospital. “Developing a growth-adaptive stent will be incredibly important in our treatment of congenital heart defects.”
“Our smallest and most fragile patients deserve the most innovative and least invasive pediatric heart valve,” said Dr. Michael Portman, a cardiologist in Seattle Children’s Kawasaki Disease Clinic and researcher at Seattle Children’s Research Institute. “If our preclinical results show promise, we will be helping to improve health outcomes for many children and families in the future.”
Emani and Portman are co-principal investigators on the award.
The smaller than 15-mm-diameter device adapts to the patient’s growth, applying a low outward force like a spring, eliminating the need for a balloon catheter or other invasive methods to expand the valve as the child grows. Draper’s novel stent design will be combined with a bioprosthetic valve, which decreases the need for aggressive anticoagulation therapy.
Corin Williams, a biomedical engineer at Draper who leads the development team, said, “Despite the great need, pediatric medical devices are challenging not just because children have unique needs compared to adults, but also represent a smaller market. We are really excited and grateful for this opportunity to move the technology forward, and get that much closer to the babies and young children who need it.”
This work was supported by the U.S. Army Medical Research Acquisition Activity, through the program “Growth-Adaptive Pediatric Heart Valves: Addressing a Critical Unmet Need for Infants and Young Children That Saves Lives and Reduces Surgeries” under award number W81XWH2010295. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.
In conducting research using animals, the investigators adhere to the laws of the United States and regulations of the Department of Agriculture.
The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office.