Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System

Inclusion Criteria:

1. Subject must be either male or non-pregnant female ≥ 18 years of age with anexpected lifespan sufficient to allow for completion of all study procedures.

2. Subject must voluntarily sign and date the Informed Consent Form (ICF) prior tocollection of study data or performance of study procedures.

3. Subject must be willing to comply with the protocol requirements, including clinicalfollow-up.

4. Subjects who have established, non-reversible kidney failure, who are currently ondialysis at screening or are in immediate need (within 6 months of endoAVF creation)of dialysis.

5. Target treatment vein diameter(s) for endoAVF creation ≥ 2.0 mm as measured viaDuplex Ultrasound (DUS) or Venography.

6. Target treatment artery diameter ≥ 2.0 mm as measured via Duplex Ultrasound (DUS) orArteriogram.

7. Subject has adequate collateral circulation to the hand, in the opinion of theInvestigator.

8. At least one superficial outflow vein diameter ≥ 2.5 mm and in communication withthe target creation site via a proximal forearm perforating vein.

Exclusion Criteria:

1. The subject is in a hypercoagulable state.

2. The subject has known bleeding diathesis.

3. The subject has insufficient cardiac output to support a native fistula in theopinion of the Investigator.

4. Known history of active intravenous drug abuse.

5. "Planned" major surgical procedure within 6 months following index procedure ormajor surgery within 30 days prior to index procedure.

6. The subject has a known allergy or hypersensitivity to contrast media which cannotbe adequately pre-medicated.

7. The subject has known adverse effects to sedation and/or anesthesia which cannot beadequately pre-medicated.

8. Evidence of active infection on the day of the index procedure (temperature of ≥ 38.0° Celsius and/ or WBC of ≥ 12,000 cells/ μL, if collected).

9. The subject has another medical condition, which, in the opinion of theInvestigator, may cause him/her to be non-compliant with the protocol, confound thedata interpretation, or is associated with a life expectancy insufficient to allowfor the completion of study procedures and follow-up.

10. The subject is currently participating in an investigational drug or another devicestudy that has not completed the study treatment or that clinically interferes withthe study endpoints. Note: Studies requiring extended follow-up visits for productsthat were investigational, but have since become commercially available, are notconsidered investigational studies.

11. The subject has central venous stenosis or central vein narrowing > 50% based onimaging on the same side as the planned endoAVF creation.

12. Absence of a proximal forearm perforating vein feeding the target cannulationvein(s) from the target creation site via Duplex Ultrasound (DUS) or Venography.

13. Occlusion or stenosis > 50% of target cannulation vein(s) such as cephalic, mediancubital, basilic, etc. assessed via Duplex Ultrasound (DUS) or Venography.

14. Significantly compromised venous or arterial flow in the treatment arm as determinedby Investigator and Duplex Ultrasound (DUS) or Venography.

15. Presence of significant calcification at the target endoAVF location that couldpotentially impact the effectiveness of endoAVF creation as determined by theInvestigator.