HLS-Diagnostic Balloon in Novel Venous Disease Model

ABSTRACT This proposal is submitted in response to notice NHLBI Announces Small Business Topics of Special InterestTOSIHLSNew animal models for the study of chronic venous insufficiencyCVIand post thrombotic syndromePTSand innovative approaches for their prevention and treatmentPost thrombotic syndrome and chronic venous insufficiency that results from outflow obstructions places one of the largest burdens on the healthcare system of any disease conditionConservative treatment of symptoms that originate from outflow obstructions are often ineffective and require endo venous intervention for correctioni evenous stentingPositive outcomes for venous stenting are limited to non thrombotic diseasehoweverdue to inadequate stent technology and poor understanding of the complexities of post thrombotic veinsEfforts to extend principles of arterial stent delivery to veins are not without pitfalls as the compliance of veins contributes toof venous stent recoil and can lead to residual stenosis and potential migration as supported byof postthrombotic stents requiring re interventionsFurtherstent under deployment is related to several factorsincluding non translatable manufacturer ex vivo to in vivo pressure diameter compliance relationsConsequentlya point of care tool is needed to provide accurate balloon sizingvein compliance and radial force information to the clinician in real time during balloon inflationTo address this needa novel peripheral reconnaissance venous balloonPRVBcatheter system has been developed that functions as a typical venous pre dilatation catheterbut with additional functionality for accurate measurement and real time display of balloon sizevessel compliance and radial forceThe PRVB catheter utilizes a predictive physical lawOhm s Lawto determine the balloon cross sectional area which is displayed in real time on a bed side console to aid the physician during balloon expansion and subsequent stent selectionPreliminary results with the PRVB catheter system on the bench and in vivo in healthy swine show excellent accuracydiameter errorand repeatabilitydiameter errorin addition to feasibility and application for direct pressure and radial force measurementsAdditional work is needed to update the console and catheterhoweverand further validate the system in a swine model of CVI and PTSthis Phase Ibefore translation to the clinicfuture Phase IIThereforewe propose the creation of a clinically ready PRVB catheter system and its validation in diseased postmortem human vessels and in vivo in a relevant model of post thrombotic syndromevenous hypertensionreflux and thrombosisBased on the fundamental physics of the technologythe excellent preliminary resultsand the previously known safety of a related systemthe PRVB catheter system is expected to provide highly accurate and repeatable real time digital display of balloon sizecompliance and radial force across the entire diseased venous segmentlesion and reference vessel diameterwith minimal physician training required NARRATIVE A venous pre dilatation device that can assess the severity of venous disease to guide stent selection and delivery is neededThe purpose of this Phase I proposal is to develop and validate a clinically relevant diagnostic balloon catheter system that provides accuratereal time information on vein sizevein compliance and radial force to improve venous stent delivery