Pivotal Study of the Velocity™ pAVF System

Exclusion Criteria

• •1. Study extremity systolic blood pressure \< 100mmHg
• •2. Subjects with occlusion of the ulnar or radial artery at any level or an abnormal Allen's test
• •3. Subjects with a previous ipsilateral arterio-venous graft or previous ipsilateral upper arm AVF.
• •4. Distance between Cubital Perforating Vein and Proximal Radial Artery \> 3.0 mm
• •5. Cephalic vein diameter \< 2.5 mm at any point from the CPV to the axillary vein
• •6. Central venous occlusion ipsilateral of the study extremity
• •7. Severe calcification of the radial artery that significantly impairs ultrasound visualization (e.g., acoustic shadowing) and thus precludes safe or accurate device deployment.
• •8. Evidence of active systemic infections or localized to the procedure access site within the past 7 days
• •9. History or evidence of severe cardiac disease (NYHA Functional Class III or IV), myocardial infarction within six months prior to study entry, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
• •10. Any contraindication to antiplatelet therapy
• •11. Currently being treated with another investigational device or drug
• •12. Known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated
• •13. Uncontrolled or poorly controlled diabetes defined as a HbA1C \> 10%
• •14. Known hypercoagulable condition, bleeding diathesis or coagulation disorder
• •15. Lymphedema of the study extremity
• •16. Scheduled kidney transplant within 6 months of enrollment
• •17. Peripheral white blood cell count \< 1,500 cells/μL or \> 13,000 cells/μL and neutrophil \> 80%
• •18. Platelet count \< 75,000 cells/ μL
• •19. Current diagnosis of carcinoma (unless in remission \> 1 year)
• •20. Pregnant or currently breast feeding
• •21. Allergies to nickel or nickel titanium alloy (NiTi) or any of the components of the Velocity Implant or Delivery System
• •22. Any other medical condition that in the opinion of the investigator would put the welfare of the subject at risk or confound interpretation of the study data
• •23. Investigator determines that vascular anatomy at intended index procedure site is inappropriate for use of investigational device prior to attempting needle access.