Trial to Assess the Effectiveness of Maintaining Patency and Safety of the Vascular Wrap Paclitaxel-Eluting Mesh After Surgical Implantation With the Lifespan® ePTFE Vascular Graft in the Upper Extremity for Hemodialysis Vascular Access

Inclusion Criteria:

1. be ≥ 18 years of age;

2. if female of childbearing potential, provide evidence of a negative pregnancy test
within 3 days prior to graft placement (Day -3 to Day 0);

3. be a candidate for a new end-to-side arteriovenous anastomosis graft placed in the
upper extremity;

4. have an outflow vein of greater than or equal to 3 mm in diameter;

5. be able to effectively communicate with study personnel;

6. be considered by the physician to be available for subsequent visits;

7. be willing to comply with all aspects of the treatment and evaluation schedule over a
52 week duration;

8. allow representatives of the sponsor, designated CRO, Institutional Review Board
(IRB), the Ethics Committee, and U.S. Food and Drug Administration (FDA) to review
his/her relevant medical records;

9. sign and date an IRB-approved written informed consent prior to initiation of any
study procedures, including screening procedures;

10. must agree to participate in protocol 014-VWAV07, a safety study to run consecutively
for an additional 4 years or until Post-Market Approval (PMA), whichever is longer;
and

11. have the Lifespan® ePTFE Vascular Graft successfully implanted.

Exclusion Criteria:

1. pregnant, breast-feeding, or female of childbearing potential who do not agree to
remain abstinent or to use a contraceptive method during the study period.
Non-childbearing potential is defined as either post-menopausal (amenorrheic for at
least 1 year) or surgically sterile. Surgically sterile is defined as tubal ligation
or the absence of the uterus and/or ovaries;

2. male of childbearing potential, who does not agree to remain abstinent or to use
contraception to prevent fathering a child during the course of the study.
Non-childbearing potential is defined as vasectomy or bilateral orchiectomy;

3. a central venous stenosis on the ipsilateral side is documented;

4. a hypercoagulable state is documented;

5. life expectancy is less than one year;

6. an organ transplant is expected within 6 months of test or control product (study
products) placement;

7. hypersensitivity to any component of the study products or procedural materials or
medications is known;

8. concurrently involved in another investigational study;

9. a study product being investigated by others has been received within 30 days prior
to randomization in this trial;

10. the study product being studied in this trial has previously been received;

11. uncontrolled hypertension with systolic BP >200mmHg or diastolic BP >115mmHg is
present at screening;

12. currently receiving chemotherapy or radiation therapy; or

13. placement of a new end-to-end arteriovenous anastomosis graft is required.