A prospective, single arm, non-randomized FIH feasibility study to evaluate the preliminary safety and performance of the Xeltis hemodialysis access graft in subjects older than 18 years with end-stage renal disease, who plan to undergo hemodialysis for at least the first 6 months after study access creation, and are deemed not suitable for fistula creation by the operating surgeon.
A feasibility study is to assess the preliminary safety and performance of the Xeltis hemodialysis access (aXess) graft.