Novel Bioabsorbable, Flexible Polymeric Stent for Pulmonary Artery Stenosis

DESCRIPTIONprovided by applicantSignificancePediatric patients with pulmonary artery stenosis face treatment options with significant limitationsFor examplemetal stents are limited by long term interference with natural vessel growthPatients implanted with metal stents are subject to multiple hospital admissions for interventional stent expansionsoften requiring fracture of the stent and openheart surgery for removalAs suchthere is an emergent need for pediatric specific devices for this underserved populationApproachIn response to a solicitation from NHLBIBiomedical developed a selfexpandingbioresorbable stent to treat pulmonary artery stenosis under a Fast Track SBIRThrough the Fast Track projectpromising animal results were achieved through the device resorption periodwhile in growing vesselsOn the strength of these Fast Track datawe raised $M of funding from Broadview VenturesThis Phase IIB SBIR application will enable advancement of this product towards commercialization applicationIn this projectfirst inhuman experience with this innovative device will be achievedDuring Yearcurrent bench and animal data will be supplemented to create a data package to enable submission of an Investigational Device ExemptionIDEfor an Early Feasibility StudyEFSThis accomplishment will enable enrollment of clinical subjects during YearYearwill be focused onmo follow up in the EFSand along with an extensive package of bench and pre clinical datathis human data will be submitted to the FDA for marketing clearanceThis project represents an important step in the commercialization of a therapy that has the potential to be a game changer for pediatric patients with pulmonary artery stenosisInnovationBiomedical s novel stent couples full bioresorption with self expansiontwo features that are ideal for the pediatric populationThis combination of properties is achieved through our unique composite designBy utilizing a strong base braid coated with a proprietary elastomerwe can achieve properties that are similar to metal in a fully resorbable designThe self expansion of this design provides the added benefit of enabling the stent to maintain apposition with the vessel wall as a pediatric patient growsThe fastyet saferesorption characteristics of the design will enable the device to "grow" with the vessel without impeding early interventionif required