The WavelinQ™ Arterio-Venous Endovascular Fistula: A Global, Post-Market Investigation

Inclusion criteria

• ✓. Be able to comprehend, voluntarily sign and date the informed consent form (ICF) prior to collection of clinical investigation data or performance of clinical investigation procedures (or where allowable the participant's legally authorized representative (LAR) on behalf of the participant).
• ✓. Be able to and willing to comply with the CIP requirements, including clinical follow-up.
• ✓. Be male or non-pregnant female ≥ 18 years of age with an expected lifespan sufficient (≥ 24 months) to allow for completion of all clinical investigation procedures.
• ✓. Have established, non-reversible kidney failure, who are currently on HD at screening or are in need of a vascular access for HD as determined by the referring clinician.
• ✓. Target treatment vein diameter(s) for AVF creation ≥ 2.0 mm as measured via DUS or angiography.
• ✓. A target treatment artery diameter ≥ 2.0 mm as measured via DUS or angiography.
• ✓. Adequate collateral circulation to the hand, in the opinion of the Principal Investigator (PI) (or authorized designee).
• ✓. At least one superficial outflow vein diameter ≥ 2.5 mm as measured via DUS or angiography that is in communication with the target creation site via a proximal forearm perforating vein.