Decellularized Femoral Artery Allograft (Nexeon AVX) Prospective Registry

Inclusion Criteria:

1. Be male or female, ≥18 years of age at the time of graft placement

2. Have a diagnosis of ESRD or renal dysfunction requiring hemodialysis

3. Subject requires dialysis access to start or maintain dialysis treatment andplacement of an AV access graft is a viable access option.

4. Have the ability themselves, or through their legal guardian, to understand therequirements of the study, to provide written informed consent/assent as evidencedby signature on an informed consent form (ICF) approved by an institutional reviewboard (IRB), and to agree to abide by the study restrictions and return to the sitefor the required assessments

5. Have provided written authorization for use and disclosure of protected healthinformation

Exclusion Criteria:

1. Be participating in a study of another investigational drug or device

2. Have a known sensitivity to any of the processing reagents utilized in themanufacture of this product such as antibiotics (Lincomycin, Polymyxin B,Ciprofloxacin, Meropenum, Gentamicin, or Vancomycin) and processing reagents (N-lauroyl sarcosine, Denarase and glycerol/glycerin)

3. Have a history or evidence of severe cardiac disease, myocardial infarction within 6months, ventricular arrhythmias, or unstable angina requiring continuing treatment

4. Have a history or evidence of severe peripheral vascular disease in the upperextremities

5. Have the inability or be unable or unwilling to follow the study visit schedule

6. Have the presence of any condition that, in the opinion of the investigator, placesthe subject at undue risk or potentially jeopardizes the quality of the data to begenerated