Evaluation of EndoRefix Endovascular Delivery System and Staple

Safety Data Collection for Delivery System and Use of Staple in Endovascular Procedures

This study is intended to provide data to verify safe delivery of a staple previously intended for use in open surgical procedures. A newly modified delivery system will provide endovascular access for implantation of a staple during endovascular graft procedures.

Inclusion Criteria:

1. Male or female >21 years of age
2. Undergoing endovascular stent grafting for AAA repair
3. Post endovascular stent grafting where stent stabilization is necessary due to stent fixation failure and/or persistent endoleak.

Exclusion Criteria:

1. Pregnant
2. Religious, cultural or other objection to the receipt of blood, or blood products.
3. Unwilling to comply with follow-up schedule
4. Unwillingness, or inability to provide informed consent to both trila and procedure
5. Ruptured Aneurysm
6. Area where staple is to be placed has significant loose thrombus associated with it
7. Acute or chronic aortic dissection or mycotoc aneurysm
8. Allergy to device materials
9. Allergy to or intolerance to use of contrast media or cannot be exposed to suitable remedial treatment such as steroids and/or diphenhydramine.
10. Clinically and morbidly obese such that imaging would be severely adversely affected.
11. Uncorrectable bleeding abnormality
12. Inflammatory aneurysm
13. Connective tissue disease (e.g., Marfans syndrome, Ehlers Danlos syndrome)
14. Patients with PTFE grafts
15. Patients with investigational grafts (i.e., those grafts that are not FDA approved)