Development of a hybrid transcatheter mitral valve replacement and repair device

PROJECT SUMMARYMitral regurgitationMRis the most prevalent valvular heart disease in the U Saffecting approximatelyof the populationThere aremillion patients in the US with moderate to severe MR requiring treatmentHoweveronly approximatelypatients in the U Sundergo surgery for MR each year due to concerns about procedural complexity and patient safetyThere is great enthusiasm among the heart valve industry and clinicians to develop transcatheter mitral valve repairTMVRepor replacementTMVRoffering less invasive treatment options for MR patientsHoweverafter more than a decade of developmentthe field of transcatheter mitral valve therapy is still in its infancyMany of the current TMVRep and TMVR devices have dismal clinical resultsCurrent transcatheter treatment methods face serious roadblocksTMVRep devices are safe but not very effectivewhile TMVR devices can be effectivebut are not yet safeIn this proposalDura Biotech proposes to develop the novel Sutra TMVR system which combines the best aspects of surgical MV replacementTMVRand TMVRep approaches to pose an elegant and effective solution for MRThe Sutra TMVR system is delivered and anchored at the mitral annulus in a three step procedure that closely mimics the surgical valve replacement process with clinically proven long term efficacyThe implanted Sutra TMVR system replaces the native posterior mitral leaflet with a novel tri leaflet prosthetic valve that mimics the native posterior mitral leaflet in design and functionto provide predictable and consistent MR reductionBecause the Sutra TMVR system only covers the posterior portion of the MVit eliminates left ventricular outflow tract obstruction seen commonly with other replacement devicesand enables a smaller device profile for safetrans septal access and deliveryThe feasibility and short term efficacy of the Sutra valve via surgical implantation have been demonstrated through in an early proof of conceptday animal studyThe goal of this SBIR project is to develop and commercialize the novel Sutra TMVR systemTo achieve this goalin Phaseof this study we will finalize the Sutra system valve and stent designs through a series of engineering analyses and experimental testsIn Phaseof this study we will first perform preclinical animal studies of the Sutra system via transcatheter implantationthen perform verification and validation tests on the final Sutra system designand finally compile the data for Investigational Device ExemptionIDEsubmission to the FDASuccessful completion of this project will yield an innovative hybrid TMVR and TMVRep device to treat the largely underserved MR patient populationPROJECT NARRATIVEThe goal of this SBIR project is to develop and commercialize a novel minimally invasive medical device for treatment of the patients who harbor a leaky mitral valvea disease condition called mitral regurgitationMRThere are aboutmillion patients in the U Swho have moderate to severe MRbut onlyof them are currently treated surgically due to the highrisk of open heart surgery