Evaluation of the Safety and Efficacy of a Vascular Prosthesis for Hemodialysis Access in Patients With ESRD

Inclusion Criteria: * Patients with end stage renal disease (ESRD) who are not, or who are no longer, candidates for creation of an autogenous AV fistula and therefore need placement of an AV graft in the upper extremity to start or maintain hemodialysis therapy * Patients between 18 and 75 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 ≥8g/dL and platelet count ≥100,000/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 INR ≤ 1.5 prior to Day 1. * Ability to communicate meaningfully with investigative staff, competence to give written informed consent, and ability 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 six months of study entry (Day 1), ventricular tachyarrhythmias requiring continuing treatment, or unstable angina * History or evidence of severe peripheral vascular disease in the upper limbs * Known o…