Xeltis Hemodialysis Access Graft: aXess Pivotal Study

Inclusion Criteria: 1. Subjects with end-stage renal disease (ESRD) who require placement of an AVG in the upper extremity to start or maintain hemodialysis therapy 2. At least 18 years of age at screening 3. Suitable anatomy (e.g. a target vein with a minimum diameter of 5mm) for the implantation of an aXess graft 4. The patient, or legal representative, has been informed about the nature of the study, agrees to its provisions, and has provided written informed consent 5. The patient has been informed and agrees to pre- and post- procedure follow-up 6. Life expectancy of at least 12 months Exclusion Criteria: 1. History or evidence of severe cardiac disease (NYHA Functional Class IV and/or EF \<25%), myocardial infarction within six months of study enrolment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina 2. Uncontrolled or poorly controlled diabetes 3. Abnormal blood values that could influence patient recovery and or/ graft hemostasis 4. Reduced liver function, defined as: \>2x the upper limit of normal for serum bilirubin, International Normalized Ratio (INR) \>1.5 or prothrombin time (PT) \>18 seconds 5. Any active local or systemic infection 6. Known heparin-induced thrombocytopenia 7. Known active bleeding disorder and/or any coagulopathy or thromboembolic disease 8. Allergies to study device (nitinol) or agents/medication, such as contrast agents or aspirin, that can't be controlled medically 9. Anticipated renal transplant within 6 months 10. Known or suspected central vein obstruction on the side of planned graft implantation 11. Previous dialysis access graft in the operative limb unless the aXess graft can be placed more proximally than the previous failed graft 12. Previous enrolment in this study 13. Subject is participating in another study 14. Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives 15. Any other condition which, in the judgement of the investigator would preclude adequate evaluation for the safety and performance of the study conduit Intra-operative exclusion criteria: 1\. Unsuitable anatomy to implant the aXess graft (e.g. target vein and/or artery diameter smaller than anticipated; severe calcification)