I-Corps: Translation potential of a transcatheter valve repair device for small anatomy patients

This I-Corps project is based on the development of a minimally invasive heart valve repair device for children and other small-anatomy patients. Children with congenital heart disease who develop “leaky valves” that allow blood to flow backward, may require repeated open-heart valve repairs or replacements throughout their lives, procedures that are invasive, technically challenging, and high risk. This technology offers a minimally invasive option delivered through a blood vessel to reduce valve leakage without opening the chest. Although catheter-based valve repair devices exist for adults, currently available systems are not designed for small anatomies, leaving many children too small or medically fragile for treatment. This technology may reduce or delay repeated open-heart surgery procedures, and may lessen recovery time, hospital burden, and risks for children. In addition, the technology may have application across multiple atrioventricular valves and other small-anatomy patient groups. This I-Corps project utilizes experiential learning coupled with first-hand investigation of the industry ecosystem to assess the translation potential of a transcatheter edge-to-edge repair (TEER) medical device designed for pediatric and other small anatomies. The TEER method reduces valve leakage by bringing the center of the valve leaflets together so they close more effectively. The method combines a catheter-delivered implant with an atraumatic tissue-engagement mechanism that captures the leaflets before securing them together. It is designed for intravascular delivery in small-anatomy patients (<12–16 French scale or approximately 4.0 - 5.3 mm). Preliminary reseach includes iterative prototype development, computational and benchtop validation through finite element analysis, mechanical force characterization, evaluation in tissue-mimicking and anatomical valve models, and development of a beating-heart flow-loop platform that simulates physiologic cardiac flow conditions. This may provide interventional cardiologists with a less invasive tool that may reduce or delay the need for open-heart surgery, particularly for small or high-risk patients who lack appropriately sized catheter-based treatment options. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.