Babies born with heart valve defects will have as many as 3-5 open heart surgeries before adulthood to replace prosthetics as they grow. Mortality and morbidity remain high, in part because there is no clinical standard for valve replacement in children under five years of age.
Eliminating even one of these surgeries would relieve these patients and their families of the health risk, stress and financial burden of a hospital stay and recovery. To address this need, Draper engineers are developing the Low-force Expanding/Adaptable Pediatric (LEAP) Valve—the first heart valve that can grow with the patient.
Eliminating Surgeries and Improving Patient Outcomes
The LEAP Valve features a stent that can expand from 7 mm to 14 mm in diameter—making it ideal for infants through children up to 5-6 years old. As the patient grows, the device expands passively, applying a low outward force—much like a spring—eliminating the need for a balloon catheter or other invasive methods to mechanically expand the device.
By combining our innovative stent with a commercially available bioprosthetic valve, the LEAP Valve also decreases the need for aggressive anticoagulation therapy, which is difficult to dose in children.
Ongoing Development and Recognition
Initially funded internally, the LEAP Valve won recognition for innovation and a prestigious FDA P50 grant from the Children’s National Health System.
The LEAP Valve also has been recognized for its innovation and promise by the American Society for Artificial Internal Organs (ASAIO).
Currently, with funding from the U.S. Army Medical Research Acquisition Activity, Draper is collaborating with pediatric clinicians at Boston Children’s Hospital and Seattle Children’s Hospital to evaluate the safety and efficacy of the device in preclinical studies. Acute animal studies are currently underway utilizing prototype devices to prove functionality of the device and develop the necessary procedures and tools for successful implementation.
Additionally, under this grant Draper is working to develop MANTIS, a mechanically based method of attaching to tissue with the potential to drastically reduce the complexity of manufacturing bioprosthetic valves.
Draper is currently collaborating on research that if approved shall result in an investigational device exemption application. Positioning the LEAP Valve for first-in-human early feasibility studies.