Development of a pediatric transcatheter pulmonary valve system

DESCRIPTIONprovided by applicantApproximatelybabies in the US and overmillion babies worldwide each year are born with congenital heart defectCHDIt is estimated thatof CHD children have specific heart defects that involve the right ventricular outflow tractRVOTand pulmonary valveThese 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 lungsTranscatheter pulmonary valve replacementTPVRis emerging as a safeless invasive alternative to surgical procedureHoweverthe only available TPVR device in the marketthe Melody valve from Medtronichas several limitationsit can only be used for patients who have a pulmonary diameter less thanmm and does not have a larger size valvethe device is a bulky device with aFr delivery systemwhich cannot be used for small pediatric patientsand its stent fracture has been extensively reportedThusthere is a clear unmet market need for a TPVR device with smaller crimped profilelarger size and good durabilityBuilding upon extensive academicclinical and industrial experiences on heart valve biomechanics and medical device designsthe team at Dura Biotech has invented Dura Valve Leaflet TechnologyDVLTfor 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 sizeThe novel DVLT design adding the reinforcement suspension structures on the valve leaflets can elegantly reduce leaflet thickness without increasing leaflet peak stress concentrationwhich is a key factor influencing mechanical damage leading to valve leaflet failureWith the DVLT designTPVR device can be smaller with thinner leaflets while maintaining durabilityThe goal of this SBIR Fast Track project is to develop and commercialize this paradigmchanging Dura TPVR deviceIn phaseof the projectwe 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 AdministrationFDAIn phasethe entire finalized TPVR system will be subjected to verification and validation tests and then evaluated for feasibility and safety through an animal studyLastlyDura Biotech will develop a strategy for quality system initiation and prepare for regulatory submission to FDASuccessful 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