Safety and Efficacy of a Vascular Prosthesis for Hemodialysis Access in Patients With End-Stage Renal Disease

Inclusion Criteria: * Patients with ESRD who are not, or who are no longer candidates for creation of an autologous AV fistula and therefore need placement of an AV graft in the upper extremity to start or maintain hemodialysis therapy * Age 18 to 80 years old, inclusive * Suitable anatomy for implantation of straight forearm grafts or curved upper arm grafts (arterial anastomosis to radial or brachial artery, venous anastomosis to either brachial cephalic or very central basilica vein) * Hemoglobin ≥8 g/dL and platelet count ≥100,000 cells/mm3 prior to Day 1 * Other hematological and biochemical parameters within a range consistent with ESRD and acceptable for the administration of general anesthesia prior to Day 1 * Adequate liver function, defined as serum bilirubin ≤1.5 mg/dL; GGT, AST, ALT, and alkaline phosphatase ≤2x upper limit of normal or international normalized ratio (INR) ≤1.5 prior to Day 1. * Able to communicate meaningfully with investigative staff, competent to give written informed consent, and able to comply with entire study procedures * Able and willing to give informed consent * Life expectancy of at least 1 year Exclusion Criteria: * History or evidence of severe cardiac disease (NYHA Functional Class III or IV), myocardial infarction within 6 months of study entry (Day 1), ventricular tachyarrhythmias requiring continuing treatment, or unstable angina * Uncontrolled or poorly controlled diabetes; hospitalization for poor glucose control within the p…