Ovine Study of Medical Device to Improve Arteriovenous Fistula Maturation

ABSTRACT This study aims to evaluate the in vivo effectiveness of the Arteriovenous Fistula EligibilityAFESystema small temporary wearable rotary blood pump system that rapidly and persistently dilates peripheral veins prior to arteriovenous fistulaAVFsurgerySuccessful 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 diameterimprove the rate of AVF maturation after AVF surgeryreduce the time required for AVF maturationprolong primary and secondary AVF patency ratesand reduce the use of hemodialysis catheters and graftsFlow Forward MedicalInchas developed a working prototype of the AFE Systemincluding the blood pumpinflow and outflow cathetersand rack mounted controllerThe device has demonstrated excellent hydrodynamic performance and minimal blood damageRecent pilot in vivo studies in an ovine forelimb model demonstrated anincrease in mean cephalic vein diameter overdays of AFE System treatment with no untoward effects on cardiovascular functionAfterweeks of maturationAVFs that were made with veins pre treated with the AFE System had mean inflow brachial artery diameters that werelarger in diametermean outflow cephalic vein diameters that werelarger in diameterand blood flows that wereX greater than control AVFs made with untreated veinsThe 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 modelAnalysis during the treatment period will include measurements of AFE System blood flow and treated cephalic vein diameterAnalysis 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 ultrasoundAnalysis at the terminal end point will include histologic analysis of the AVFs with morphometryBased upon the success of Phase IPhase 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 PROJECT NARRATIVE There are overpatients with end stage renal disease in the US who depend on hemodialysisCreating effective and reliable vascular access sites that can connect patients to hemodialysis machines remains a major unmet clinical needHemodialysis patients who use an arteriovenous fistulaAVFfor vascular access live longerhealthier lives and cost less to care forHoweveraboutof hemodialysis patients in the US are ineligible for AVF surgerymostly due to inadequate vein diameterand must use arteriovenous grafts and catheters for hemodialysis accesssubjecting them to higher failure ratesmore complicationsand higher costsFor those patients who have adequate peripheral veins and are eligible for AVF surgerymore thanwill experience maturation failurewith a substantial number of those AVFs being subsequently abandoned prior to regular usePrior studies have shown much higher rates of successful maturation after AVF surgery for patients with larger initial vein diametersFlow Forward Medical s AFE System is designed to rapidly and persistently dilate peripheral veinsenabling nearly all hemodialysis patients to be eligible for an AVF and reducing their subsequent risk of AVF failure