LifeNet Health
Post market registry to assess the safety and efficacy of a novel decellularized human femoral artery allograft (Nexeon AVX Decellularized Femoral Artery,
The clinical objective of this prospective, observational, post market registry study, CR-21-005, is to assess the safety and efficacy of a decellularized human femoral artery allograft (Nexeon AVX Decellularized Femoral Artery, LifeNet Health, Virginia Beach, VA) in the creation of vascular access for hemodialysis in patients with ESRD.
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 and placement of an AV access graft is a viable access option. 4. Have the ability themselves, or through their legal guardian, to understand the requirements of the study, to provide written informed consent/assent as evidenced by signature on an informed consent form (ICF) approved by an institutional review board (IRB), and to agree to abide by the study r…
Nexeon AVX allograft for hemodialysis access in end stage renal disease
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