A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End Stage Renal Disease

Inclusion Criteria:

Pre-Operative Inclusion Criteria:

Patients must meet the following criteria at screening in order to be scheduled for a procedure and potentially enrolled in the study:

1. Patients with ESRD whose next most appropriate option for AV access is placement ofan AV graft to start or maintain hemodialysis therapy;

2. Age 18 to 90 years old, inclusive;

3. Suitable anatomy for implantation of upper arm "straight" or looped graft, orforearm looped graft (graft not to cross the bend of the elbow);

4. Ability to continue or commence antiplatelet therapy post graft implant (anticoagulation medication is acceptable if the subject is required to take ananticoagulant for a baseline medical condition);

5. Able and willing to give informed consent;

6. Anticipated life expectancy of at least 1 year.

Intra-Operative Inclusion Criteria:

Both vessels have been exposed and are deemed appropriate for implantation (i.e., based on the surgeon's opinion, artery is of adequate size, has adequate pulse to support AV access flow, is without significant calcification, and is safely clampable; and the vein is of adequate size, free of localized sclerosis, and is free of immediate outflow obstruction).

Pre-Operative Exclusion Criteria:

Patients will be excluded from the study at screening if they exhibit any of the following exclusion criteria:

1. History or evidence of severe cardiac disease (i.e., debilitating heart failure, orhigh risk of MI) in the opinion of the investigator which may preclude participationin and completion of the study;

2. Uncontrolled diabetes in the opinion of the investigator (i.e., multiple recentdiabetes related hospitalizations);

3. For upper arm straight configuration, an antecubital fossa crease to axillary creasedistance < 18 cm;

4. History or evidence of severe peripheral arterial disease in the extremity selectedfor implant (i.e., arterial inflow insufficient to support hemodialysis access);

5. Known or suspected central vein stenosis or obstruction on the side of planned graftimplantation;

6. Baseline hypotension or history of frequent hypotensive episodes during dialysisthat, in the opinion of the investigator, puts the patient at increased risk ofgraft thrombosis;

7. Uncontrolled hypertension, per the opinion of the investigator (i.e., recent historyof recurrent hospitalizations for hypertensive related illness);

8. Baseline hemoglobin <7 g/dL;

9. Baseline platelet count <50,000 or >500,000 cells/mm3;

10. Documented history of stroke within 6 months prior to enrollment;

11. Treatment with any investigational drug or device within 30 days prior toenrollment;

12. Female patients who are pregnant, intending to become pregnant, nursing or intendingto breastfeed during the study (pregnancy test may only be omitted, if patient ispost-menopausal or has a documented history of hysterectomy or permanentsterilization);

13. History of cancer with active disease or treatment within the previous year, exceptfor non-invasive basal or squamous cell carcinoma of the skin;

14. Immunodeficiency including documented history of human immunodeficiency virus (HIV)or acquired immunodeficiency syndrome (AIDS) or patients receiving immunosuppressivetherapy for treatment of an acute inflammatory event or autoimmune flare. Chronicimmunosuppressive therapy is acceptable;

15. Documented or suspected hypercoagulable condition;

16. Bleeding diathesis, other than that associated with ESRD;

17. Documented history of heparin-induced thrombocytopenia (HIT);

18. Active local or systemic infection as documented from the medical history orbloodwork/blood culture data. If the infection resolves, the subject must be atleast one-week post resolution of that infection before implantation;

19. Scheduled renal transplant within 6 months;

20. Any other condition which in the judgment of the investigator would precludeadequate evaluation of the safety and effectiveness of the IG;

21. Patient is unable or unwilling to complete all required follow-up assessments andquestionnaires.