Confirmatory Study to Assess the V Needle in End-Stage Renal Disease Patients During In-Clinic Hemodialysis

Inclusion Criteria:

1. Subjects with end-stage renal disease receiving chronic hemodialysis in a clinical setting.
2. Subjects must be able to receive hemodialysis with the Hemotek 15-gauge, 1 inch length V Needle, with 12 inch tubing.
3. Age greater than or equal to 22 years old at screening.
4. Vascular access via a mature arteriovenous (AV) fistula or graft in the arm and determined to be adequate for a chronic hemodialysis therapy.
5. AV fistula has already been demonstrated to adequately permit one or more hemodialysis sessions.
6. Subject prescribed blood flow rates between 200 ml/min and 450 ml/min
7. In women with child-bearing potential, negative urine or serum pregnancy test at Screening.
8. Subject able to communicate effectively with investigative staff, competent and willing to give written informed consent, and able to comply with entire study procedures.
9. Hemoglobin ≥9 g/dL (consistent with KDOQI guidelines)
10. Normal platelet count (≥150,000 /mm3)
11. International Normalized Ratio (INR) ≤ 1.5

Exclusion Criteria:

1. Subjects receiving chronic hemodialysis with a vascular catheter.
2. Subjects with vascular access that is determined by the clinician to be unacceptable for a hemodialysis procedure.
3. Patients with a bleeding diathesis
4. Patients receiving anti-coagulants
5. Previous vascular access surgery (≤30 days from study entry) or planned access surgery
6. Known hypersensitivity to any imaging agents (e.g., contrast) that may be required during the study period
7. Patients with confirmed vasculitis
8. Vascular access infection or systemic active infection within 30 days of study entry
9. Life expectancy less than 12 months
10. Planned renal transplantation or planned conversion to peritoneal dialysis
11. Subjects with any condition determined by the investigator that precludes them from safely participating in the study.