Unmet Medical Need: Of the 1.3 million babies born worldwide each year with congenital heart disease, more than 400,000 require implantation of a prosthetic valve during their childhood. Currently, these prostheses are of a fixed size. Before reaching adulthood, children with prosthetic heart valves must undergo multiple open-heart surgeries to replace the valves as they grow.

Envisioned Healthcare Product:  We have developed a polymer prosthesis that accommodates a child’s growth via non-invasive transcatheter balloon dilation. This device is initially intended for pulmonic valve replacement and has the potential to improve outcomes and quality of life for 155,000 children/adolescents per year globally and decrease healthcare costs by reducing open heart reoperations.

Stage of Development:  Pre-clinical Evaluation

Collaborative Research Team: David Kalfa, MD, PhD and Jeffrey Kysar, PhD 

Funding Cycle: 2020-21