HeRO Vascular Access Device Bacteremia Study

Inclusion Criteria:

1. 21 years of age or older.

2. Male or non-pregnant female.

3. Life expectancy less than 1 year.

4. ESRD on hemodialysis with poor remaining venous access sites for creation of an AV
fistula or placement of a graft in the upper extremities.

5. Implant side central venous system that surgeon believes can be accessed with
interventional devices and can accommodate the 19 Fr GVAS device.

6. Potential GVAS target brachial artery ≥ 3 mm in diameter determined by any suitable
measure.

7. Ability to understand and provide written informed consent.

8. Willing and able to cooperate with follow-up examinations.

Exclusion Criteria:

1. Documented history of drug abuse within six months prior to enrollment.

2. "Planned" concomitant surgical procedure or previous major surgery within 30 days,
excluding vascular access related procedures.

3. Currently being treated with another investigational device or drug.

4. Known bleeding diathesis or hypercoaguable state.

5. Peripheral white blood cell count 1.5 K/mm3 or platelet count 50 K/mm3.

6. Degenerative connective tissue disease, e.g., Marfan's and Ehlers Danlos Syndrome.
Subjects with Lupus Erythematosus may be enrolled if receiving no immunosuppressants
or low dose prednisone only (< 10 mg/day orally).

7. Subjects with known or suspected concomitant active bacterial, fungal, viral, or
parasitic infection. Subjects with Hepatitis B and/or Hepatitis C may be enrolled.
Subjects who are HIV + with CD4 count of < 200 are excluded. Subjects with bacteremia
within the past six (6) weeks must have negative blood cultures one week after
completing appropriate antibiotic therapy prior to enrollment.

8. Severe underlying co-morbidity or immediate life-threatening condition.

9. Subjects with any condition which, in the opinion of the investigator, could preclude
evaluation of response or completion of follow-up or affect subject safety.

10. Subjects with significant arterial occlusive disease which would preclude safe
placement of an upper extremity hemodialysis access.

11. Subjects with history or findings on physical examination suggesting significant
arterial insufficiency that could affect patient safety and/or device performance in
the extremity planned for use with GVAS (i.e., steal syndrome, hand ischemia,
peripheral arterial vascular disease, etc.).

12. Subjects with scheduled kidney transplant within the next 12 months.

13. Subjects with history of superior vena cava syndrome are excluded unless it was
induced by previous access (these subjects can be enrolled).

14. Subjects with history of decreased cardiac output with ejection fraction < 20% and/or
NYHA class III or IV. NYHA definitions: Class III - Subjects with marked limitation of
activity; they are comfortable only at rest; Class IV - Subjects who should be at
complete rest, confined to bed or chair; any physical activity brings on discomfort
and symptoms occur at rest.

15. Subjects with history of uncorrected hypotension with systolic blood pressures
routinely < 100 mg Hg.

16. Subjects who currently have a pacemaker or ICD in their central venous system on the
same side where the GVAS device would be implanted.