Medical Device to Improve Arteriovenous Fistula Maturation

Period of Performance: 07/01/2015 - 06/30/2016

$225K

Phase 1 SBIR

Recipient Firm

Flow Forward Medical, Inc.
Olathe, KS 66061
Principal Investigator

Abstract

DESCRIPTION (provided by applicant): This study aims to evaluate the in vivo effectiveness of the Arteriovenous Fistula Eligibility (AFE) System(tm), a small temporary wearable rotary blood pump system designed to rapidly and permanently dilate peripheral veins. Successful commercialization of the AFE System would enable the creation of arteriovenous fistula (AVF) vascular access sites in hemodialysis patients who are currently ineligible because of inadequate vein diameter, as well as to reduce AVF maturation failure in patients who are eligible but at high risk for failure. Flow Forward Medical has developed a working prototype of the AFE System, including the blood pump component, demonstrating excellent hydrodynamic performance and minimal blood damage. Recent pilot in vivo studies in a pig model have shown rapid and substantial vein dilation with only minimal vein wall scarring, and without acute effects on cardiovascular function. Using this model, the AFE System outflow vein showed 20X faster dilation and 75% less neointimal hyperplasia during vein maturation when compared to the outflow veins of conventional AVFs. The objective of this proposed Phase I program is to compare AVFs made using AFE System- treated veins and untreated veins in a porcine model. Analysis will involve hemodynamics, angiography, and histology. Based upon the success of Phase I, Phase II of the program will include studying the AFE System in a uremic pig model, development of wearable electronics, GLP animal studies to evaluate the final device design, and preparations for a first-in-man clinical trial.