Study to Evaluate the Performance and Safety of Expedial and Compare it to Expanded Polytetrafluoroethylene (ePTFE) Vascular Access Grafts

Inclusion Criteria:

• Patient has chronic renal failure and requires vascular access for hemodialysis
• Patient has given informed consent to participate in the trial and is willing to comply with the study protocol
• Patient is male or female, 18 years of age or older
• The vascular access graft can be placed in the upper extremity (forearm, including across the elbow, or upper arm)
• Patient is undergoing or will undergo hemodialysis at a hospital or hemodialysis center
• Patient has a vein 4 mm or larger to which the graft can be anastomosed

Exclusion Criteria:

• Patient is unable to comply with the study follow-up
• Patient has a known sensitivity to polyurethane or porcine heparin
• Patient has a previous vascular access graft implanted and it is not possible to place the study graft proximal to the existing device and no other sites are available
• Patient has an immunodeficiency syndrome
• Patient has a prior history of bacterial infection within 8 weeks of implantation of graft
• Patient has a severe coagulation disorder
• Patient has an elevated platelet count of greater than 1 million
• Patient has a history of heparin-induced thrombocytopenia syndrome (HIT)
• Patient is pregnant
• Patient has a fever greater than 100 degrees Fahrenheit