POLYNOVA CARDIOVASCULAR INC — Department of Health and Human Services STTR Phase I: NHLBI

Description

Project SummaryA Novel Polymeric Valve for Transcatheter Aortic Valve Replacement Minimally invasive transcatheter aortic valve replacementTAVRhas emerged as an effective therapy for the unmet clinical need of inoperable patients with severe aortic stenosisASRecent longitudinal follow up studies of TAVR patients however indicate that this procedure and associated technology may result in serious adverse eventsCurrent technology is based on tissue valves adapted tobut not specifically designed for TAVRThose may sustain damage during crimping as well as deploymentare susceptible tobone likecalcific depositionand suffer from limited durabilityOur group has developed a novel valve that is specifically designed to tackle the numerous challenges that a TAVR valve will meet during its life cyclefrom crimping to deployment and long term performance in situIt incorporatesinovel polymer technologyxSIBSwhich combines superior bio stability together with excellent mechanical propertiesandiia novel design optimization methodology of the leaflets profile for enhanced hemodynamicdurabilityand thromboresistance performanceOur broad objective is to develop a viable and durable TAVR valve that will propose a real alternative to existing bioprosthetic aortic valvesand allow a long term solution adequate for broader segment of the populationThis Phase I STTR projectin a collaboration between Stony Brook University and PolyNova Cardiovascular Incaims to shift our existing novel polymeric prosthetic heart valve to a TAVR applicationproviding proof of conceptThis will be tested in four aimsAimanalyses the hydrodynamic performance in silico both in standard as well as in patientspecific anatomyquantify its thrombogenic potentialand compares it to a commercially available valveAimtests the hydrodynamic performance in vitrousing standard and patient specific anatomyand evaluates damage to the polymer as a result of valve crimpingAimquantifies the thromboresistance profile of the valve via platelet activation under physiological flow conditionsAimevaluates the durability performance and calcification susceptibility under accelerated wear testing conditionsSuccessful accomplishment of the above aims will lead to a breakthrough in the treatment of aortic valve diseasesproviding an affordablelong termminimally invasive solutionenhancing the life of a much broader patient population