PATH-03 Paraguay Feasibility Study

Exclusion Criteria

• •1. Significant central venous stenosis or narrowing that exceeds 50% based on imaging
• •2. Hypercoagulable state or known bleeding diathesis
• •3. NHYA Class III or IV heart failure
• •4. Estimated life-expectancy of \<1 year based on the physician's opinion
• •5. Oedema of extremities
• •6. Current diagnosis of carcinoma
• •7. Pregnant or breastfeeding women
• •8. Diagnosed or suspected skin disease at the access site
• •9. Immunosuppression or otherwise immunocompromised patients
• •10. Currently being treated with another investigational device or medication
• •11. Allergy to contrast or other drugs associated with surgery, e.g., sedation agents, or to device materials
• •12. Anatomy that prevents formation of AVF, e.g., misalignment of vessels or tortuosity
• •13. Patient is unwilling to undergo 2nd stage procedure, e.g. endovascular prothesis placement or balloon dilatation, if required