Xeltis Hemodialysis Access Graft (aXess) US Study

A multi-center, prospective, single-arm, non-randomized, staged, pivotal clinical study to evaluate the safety and performance of the aXess graft in subjects aged 18 and above, diagnosed with end-stage kidney disease, and possessing an estimated glomerular filtration rate (eGFR) less than 20 ml/min, who intend to undergo hemodialysis but are considered unsuitable candidates for fistula creation by the investigating surgeon.

Inclusion Criteria: 1. Subjects with end-stage renal disease (ESRD) who require placement of an AVG in the upper extremity to start (within the first 6 months of follow-up) or maintain hemodialysis therapy and are deemed unsuitable for fistula creation by the investigational surgeon. 2. At least 18 years of age at screening. 3. Suitable anatomy (e.g. a target vein with a minimum diameter of 4mm) for the implantation of an aXess graft 4. The patient 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 \