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

Description

ABSTRACT Peripheral arterial disease may lead to critical limb ischemia and results in amputation of the limb in severe manifestationsThe prevalence rate of peripheral arterial disease increases fromin those younger thanyears toin thoseyears or olderIn the United Statesovermillion individuals have lower extremity PADwith combined annual costs exceeding $billionSurgical bypass of the diseased peripheral arterial segment is one of the main treatments for the patients with life limiting claudication or critical limb ischemiaAutogenous vein graft is the most commonly used conduit in the bypass surgeryUnfortunatelythere are a limited number of bypasses that can be made from autogenous vein graftsCurrent alternative approaches include synthetic materialacellular scaffoldsand tissue engineered graftsbut all have failed to produce a functional small diameter graftThusthere is a critical need for readily available grafts for bypass surgeryIn this proposalwe will evaluate the pulmonary visceral pleuraPVPas a novel biological scaffold for bypass surgery in peripheral arterial diseaseOur group has preliminary data showing small diametermmglutaraldehyde fixed PVP grafts remain patent atmonths in a rat model where the graft fully and functionally arterializes and with no indications of calcification or aneurysmIn this proposalwe aim to expand upon our preliminary findings and evaluate the safety and efficacy of PVP as small diametermmgrafts for peripheral artery surgery in a swine modelThis proposal addresses a clinically very significant problem and successful completion will provide surgeons with numerous conduit size optionsto minimize SV harvestingand reduce procedure time and healthcare costs NARRATIVE Surgical bypass of obstructive artery is one of the most widely performed operations in peripheral arterial disease but is limited by a critical need for readily available small diameter vessel graftsThe purpose of this Phase I SBIR is to test and validate the pulmonary visceral pleura as a small diameter vessel graft for bypass surgery