Research Project
9555535
ABSTRACT This study aims to evaluate the in vivo effectiveness of the Arteriovenous Fistula Eligibility (AFE) System?, a small temporary wearable rotary blood pump system that rapidly and persistently dilates peripheral veins prior to arteriovenous fistula (AVF) surgery. Successful commercialization of the AFE System would enable the creation of AVF vascular access sites in hemodialysis patients who are currently ineligible because of inadequate vein diameter, improve the rate of AVF maturation after AVF surgery, reduce the time required for AVF maturation, prolong primary and secondary AVF patency rates, and reduce the use of hemodialysis catheters and grafts. Flow Forward Medical, Inc. has developed a working prototype of the AFE System, including the blood pump, inflow and outflow catheters, and rack-mounted controller. The device has demonstrated excellent hydrodynamic performance and minimal blood damage. Recent pilot in vivo studies in an ovine forelimb model demonstrated an 86% increase in mean cephalic vein diameter over 6 - 11 days of AFE System treatment with no untoward effects on cardiovascular function. After 6 weeks of maturation, AVFs that were made with veins pre-treated with the AFE System had mean inflow brachial artery diameters that were 28% larger in diameter, mean outflow cephalic vein diameters that were 52% larger in diameter, and blood flows that were 4X greater than control AVFs made with untreated veins. The objective of this proposed Phase I program is to complete a larger study evaluating cephalic vein diameter before and after AFE System treatment and comparing the maturation of AVFs made using AFE System-treated veins and untreated veins in a newly developed ovine model. Analysis during the treatment period will include measurements of AFE System blood flow and treated cephalic vein diameter. Analysis during the six week AVF maturation period will include weekly measurements of AVF inflow artery and outflow vein diameter by angiography and AVF blood flow by ultrasound. Analysis at the terminal end point will include histologic analysis of the AVFs with morphometry. Based upon the success of Phase I, Phase II of the program will include a GLP animal study with a commercial version of the AFE System and preparations for a US clinical trial.
