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.
Public Health Relevance Statement: Public Health Relevance: There are about 400,000 patients with end-stage renal disease in the U.S. who depend on hemodialysis for their survival. Creating effective and reliable vascular access sites that can connect patients to hemodialysis machines remains a major unmet clinical need. Hemodialysis patients who use an arteriovenous fistula (AVF) for vascular access live longer, healthier lives and cost less to care for. However, only about 55% of hemodialysis patients in the U.S. use an AVF, mostly because of inadequate vein diameter and high rates of failure after AVF surgery due to vein narrowing. Prior studies have shown much higher success rates from AVF surgery for patients with larger initial vein diameters. Flow Forward Medical's AFE System(tm) is designed to rapidly and permanently dilate peripheral veins, enabling nearly all hemodialysis patients to be eligible for an AVF and reducing their subsequent risk of AVF failure.
Project Terms: Acute; Address; Aftercare; Angiography; Animals; Anticoagulants; antimicrobial; Arteries; Arteriovenous fistula; base; Biological; Blood; Blood flow; Blood Pressure; blood pump; Blood Vessels; Caliber; Cardiovascular Physiology; Caring; cell injury; Cicatrix; Clinical; Clinical Trials; commercialization; cost; design; Device Designs; Devices; Distal; Dose; Effectiveness; Electronics; Eligibility Determination; End stage renal failure; Erythrocytes; Evaluation; Failure (biologic function); Family suidae; femoral artery; Government; Hemodialysis; hemodynamics; Hemoglobin; high risk; Histology; Hyperplasia; improved; In Vitro; in vivo; Lateral; Lead; Life; Limb structure; Maintenance; man; Marketing; Medical; Medical Device; meetings; model development; Modeling; Obstruction; Operative Surgical Procedures; Patient Care; Patients; Performance; Peripheral; Persons; Phase; Physicians; Plasma; Platelet Count measurement; Polytetrafluoroethylene; Polyurethanes; Preparation; Procedures; programs; prototype; public health relevance; Pump; repaired; Research; Risk; Saphenous Vein; shear stress; Side; Site; Stenosis; success; Superior vena cava structure; Surgical Anastomosis; System; Techniques; treatment duration; Upper arm; Veins; Work
