Initial Safety Study of the TRUE AVC in Hemodialysis Access (TRUE AVC I Study)

Inclusion Criteria:

1. Patients with end stage kidney disease (ESKD) who are poor candidates for creationof a simple autogenous AV fistula (without requiring transposition) and thereforeneed placement of an AV access in the upper extremity to start or maintainhemodialysis therapy.

2. Either on hemodialysis or expected to start hemodialysis within 12 weeks of studyconduit implantation.

3. Patients between 18 and 75 years old, inclusive.

4. Verify adequate arterial flow and venous runoff using duplex ultrasound andvenogram. Ensure outflow vein is at least 5 mm in diameter with good compliance.

5. Hemoglobin ≥8g/dL and platelet count ≥100,000/mm3 prior to implant.

6. Other hematological and biochemical parameters within a range consistent with ESKDand acceptable for the administration of regional or general anesthesia prior toimplant.

7. Adequate liver function, defined as serum bilirubin ≤1.5 mg/dL; GGT, AST, ALT, andalkaline phosphatase ≤2x upper limit of normal or INR ≤ 1.5 prior to implant.

8. Life expectancy of at least 1 year.

9. Negative COVID-19 test within 3 days prior and negative for symptoms within 14 daysprior to implant.

10. Female subjects must be either:

11. Of non-childbearing potential, which is defined as post-menopausal (at least 1year without menses prior to Screening) or documented surgically sterile orpost hysterectomy (at least 1 month prior to Screening)

12. Or, of childbearing potential, in which case: i. Must have a negative urine blood pregnancy test at Screening, and ii. Must agreeto use at least one form of the following birth control methods for the duration ofthe study:

13. Established use of oral, injectable or implanted hormonal methods of contraception

14. Placement of an intrauterine device or intrauterine system 3. Barrier methods ofcontraception: condom or occlusive cap (diaphragm or cervical/vault caps) withspermicidal foam/ gel/ film/ cream/ suppository 11. Able to communicate meaningfullywith investigative staff and able to comply with entire study procedures.

15. Willing and competent to give written informed consent

Exclusion Criteria:

1. History or evidence of severe cardiac disease (NYHA Functional Class III or IV);myocardial infarction within six months prior to study entry; ventriculartachyarrhythmias requiring continuing treatment; unstable angina; or ejectionfraction < 50%.

2. Uncontrolled or poorly controlled diabetes defined as A1C > 8; hospitalization forpoor glucose control within the previous 6 months.

3. History or evidence of severe peripheral vascular disease in the upper limbs

4. Known or suspected central vein obstruction on the side of planned study conduitimplantation. Avoid patients with current subclavian catheters or leads on the sideof the study conduit implant. If the patient had previous subclavian catheters orleads on the implant side, verify adequate runoff with a venogram.

5. Documented hypercoagulable state or history of thromboembolic events or history ofrepeated venous catheter clotting.

6. Known Positive COVID 19 test result or known exposure to COVID 19 in past 3 months.

7. Known active infection including dental infection, osteomyelitis and otherconditions which could present a local or systemic risk of infection.

8. Bleeding diathesis.

9. Contraindication to or known serious allergy to anticoagulant, aspirin, or plannedantiplatelet therapy. History of heparin-induced thrombocytopenia.

10. Immunodeficiency including AIDS / HIV or active autoimmune disease, or onimmunosuppressant therapy.

11. Autoimmune nephropathy

12. Previous PTFE graft in the operative limb unless the TRUE AVC can be placed moreproximally than the previous failed graft.

13. More than 1 failed PTFE graft in the operative limb.

14. Patients receiving an AV access which crosses the elbow.

15. Patients receiving a lower extremity AV access.

16. Treatment with any investigational drug or device within 60 days prior to studyentry or ongoing participation in a clinical trial of an investigational product.