First-in-Human (FIH) Study of the Xeltis Hemodialysis Access Graft

Inclusion Criteria: * Subjects older than 18 years with end-stage renal disease (ESRD) who are not, or who are no longer, candidates for creation of an autogenous AV fistula, and therefore require placement of an AV graft in the upper extremity to start or maintain hemodialysis therapy * Suitable anatomy for the implantation of an aXess graft * The patient has been informed about the nature of the study, agrees to its provisions, and has provided written informed consent * The patient has been informed and agrees to pre- and post- procedure follow up * Life expectancy of at least 12 months Exclusion Criteria: * History or evidence of severe cardiac disease (NHYA Functional Class IV and/or EF \<30%), myocardial infarction within six months of study entry, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina * Stroke within six months before study entry * Active clinically significant autoimmune / inflammatory disease, immunodeficiency (including AIDS / HIV), use of immunosuppressive therapy or medication that likely interferes with restorative therapies * Abnormal blood values (e.g. leurkopenia with white blood cell (WBC) count \< 4,000/mm3 and/or anemia with hemoglobin \<8g/dL and/or thrombocytopenia \< 100,000/mm3) that could influence patient recovery and/or graft hemostasis * Any active local or systemic infection (WBC \> 15,000/mm3) * Uncontrolled or poorly controlled diabetes (hemoglovin A1c \> 8% despite standard care) or hospitalization fo…