Approximately 40,000 babies in the US and over 1 million babies worldwide each year are born with congenital heart defect (CHD). It is estimated that 20% of CHD children have specific heart defects that involve the right ventricular outflow tract (RVOT) and pulmonary valve. These pediatric patients are typically subjected to multiple invasive open-heart surgeries throughout their lifetime in order to reestablish normal blood flow from the heart to the lungs. Transcatheter pulmonary valve replacement (TPVR) is emerging as a safe, less invasive alternative to surgical procedure. However, the only available TPVR device in the market, the Melody valve from Medtronic, has several limitations: it can only be used for patients who have a pulmonary diameter less than 24.5 mm and does not have a larger size valve; the device is a bulky device with a 22 Fr delivery system, which cannot be used for small pediatric patients; and its stent fracture has been extensively reported. Thus, there is a clear unmet market need for a TPVR device with smaller crimped profile, larger size and good durability. Building upon extensive academic, clinical and industrial experiences on heart valve biomechanics and medical device designs, the team at Dura Biotech has invented Dura Valve Leaflet Technology (DVLT) for developing low profile TPVRs that could fit within the various anatomic configurations across a range of pulmonic diameters that extended from young child to full adult size. The novel DVLT design-adding the reinforcement suspension structures on the valve leaflets-can elegantly reduce leaflet thickness without increasing leaflet peak stress concentration, which is a key factor influencing mechanical damage leading to valve leaflet failure. With the DVLT design, TPVR device can be smaller with thinner leaflets while maintaining durability. The goal of this SBIR Fast-Track project is to develop and commercialize this paradigm- changing Dura TPVR device. In phase 1 of the project, we proposed to finalize the valve and stent designs of the TPVR device through a series of computational and experimental tests to meet customer requirements as well as all criteria specified by the Federal Drug Administration (FDA). In phase 2, the entire finalized TPVR system will be subjected to verification-and-validation tests and then evaluated for feasibility and safety through an animal study. Lastly, Dura Biotech will develop a strategy for quality system initiation and prepare for regulatory submission to FDA. Successful completion of this project will yield an innovative TPVR device to treat an untapped population of patients with RVOT and PV diseases and improve patient outcomes.
The goal of this SBIR project is to develop and commercialize the Dura Biotech TPV Device, a low profile transcatheter pulmonary valve replacement device for the treatment of congenital heart defects, specifically RVOT failure in pediatric patients. The TPVR device addresses an immediate market need for a low profile and durable TPVR device designed for implantation in the pulmonary position.