3DT HOLDINGS, LLC — Department of Health and Human Services SBIR Phase II: NHLBI

Description

ABSTRACT TransseptalTSaccess for left heart procedures is an important and rapidly growing area for diagnostics and therapy delivery with an expected total of overmillion U SpatientsIn the U Sand EuropeTS access procedures are used for atrial fibrillation ablationleft atrial appendage occlusion and patent foramen ovale closure as well as treatment of mitral valve regurgitation with the MitraClipMCCatheter positioning and device placement for MC has been challenging even for the most experienced interventionalist cardiologistsICsand has led to long procedure times with significant x ray exposureThis emerging therapy necessitates a higher level of catheter stability and control over accuracy during puncture of the fossa ovalisFOIf the initial puncture is inaccuratedelivery of therapy is virtually impossible which often requires removalre engagement and device re advancementThusinitial localization and stabilization on the FO is critical for MC procedures to limit delivery times and x ray exposureAdditionallythe presence of aneurysmal or fibrotic FO and the constant movement of the heart makes standard TS access puncture unpredictable and contributes to increased risk for atrial or aortic perforationTo overcome these limitationswe have developed and validated the performance and utility of a novel transseptal access catheterTSACthat utilizes vacuum suction technology to provide improved catheter localization and stabilization of the FOThe results of our preclinical studies were highly successful and support that through stabilization of the FOfold reduction in puncture forcethe TSAC reduces tentingfoldto improve puncture accuracyfoldcompared to standard TS access devices in a clinically relevant animal model of mitral regurgitationIn this Phase II applicationwe propose an investigational device exemptionIDEto conduct a human pilot study which will be used to assess primarily device safety and secondarily device feasibility in patients undergoing TS access for MC deliveryTo accomplish these Phase II objectivesthe following specific aims are proposedFinal Animal ValidationTo assess the safety of the TSAC in a set of animals under good laboratory practiceGLPconditions to be used for data submission to the FDA and institutional review boardsIRBsandHuman ValidationTo assess the contribution of human factors to feasibility in a small group of humanspatientsin a double arm multi center studyThis Phase II study addresses a highly significant national and worldwide clinical need that can impact not just NHLBIbut many other mission areas of NIHSuccessful completion of these proposed Aims will allow us to translate our research findings to a commercially available device that could drastically improve TS access procedures and hencepatient outcomes