In the pediatric population the growth of the patient relative to the valve prosthesis necessitates reoperations to implant larger valves until the patient is fully grown. These operations introduce an increased risk of mortality, and there are no prosthetic valves on the market that have demonstrated the potential to grow and remodel into the patient’s own tissue. Thus, there is a great need for a valve that will not elicit adverse responses and that will grow and remodel with the patient. Congenital heart defect patients have few options for valvular replacements. Current valve replacements are homografts, xenografts, tissue valves, mechanical valves, or the Ross procedure.
This product will be targeted to children 2-12 years old to treat congenital absence, malformation, or stenosis of aortic valves. This valve will grow with children thus eliminating the need for future valve replacement.10, 000 pediatric aortic valves are replaced annually in the U.S. The valve will remodel clinically into normal tissue and has been shown to recruit stem cells and combat bacterial infection. It has been used preclinically as a valve conduit in the pulmonary position with excellent results.
APDC helped by providing funding to move this project to the forefront of our R&D strategy. Prior to receiving this funding we had performed preclinical studies to investigate valve function for different valve designs in other locations (tricuspid and pulmonary), but the aortic valve, because of the challenges encountered with the higher pressure on the left side of the heart, was not approved for funding. Now we can initiate these studies to investigate not only our novel valve design but also the biocompatibility and potential remodeling of our ECM in the aortic position. Pending the outcome of our studies, we will be able to use these data for an SBIR grant and also obtain more company funding to continue this project. When the project joined the consortium the device was in the prototyping stage of development.