Xeltis Hemodialysis Access (aXess) Conduit: aXess-E Study

Inclusion Criteria:

1. Subjects with end-stage renal disease (ESRD) who require placement of anArteriovenous Graft (AVG) in the upper extremity to start or maintain hemodialysistherapy

2. At least 18 years of age at screening

3. Suitable anatomy (e.g. a target vein with a minimum diameter of 5mm) for theimplantation of an aXess-E conduit

4. The patient has been informed about the nature of the study, understands and agreesto its provisions, and has personally 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 (New York Heart Association (NYHA)Functional Class IV and/or Ejection Fraction (EF) <25%), myocardial infarctionwithin six months of study enrolment, ventricular tachyarrhythmias requiringcontinuing treatment, or unstable angina

2. Uncontrolled or poorly controlled diabetes

3. Abnormal blood values that could influence patient recovery and or/ conduithemostasis

4. Reduced liver function, defined as: >2x the upper limit of normal for serumbilirubin, International Normalized Ratio (INR) >1.5 or prothrombin time (PT) >18seconds

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 oraspirin, 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 conduitimplantation

11. Previous dialysis access conduit in the operative limb unless the aXess-E conduitcan be placed more proximally than the previous failed conduit

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 adequatecontraceptives

15. Any other condition which, in the judgement of the investigator would precludeadequate evaluation for the safety and performance of the study conduit

Intra-operative exclusion criteria:

1. Unsuitable anatomy to implant the aXess-E conduit (e.g. target vein and/or arterydiameter smaller than anticipated; severe calcification)