GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms

This is a prospective, non-randomized study designed to assess the feasibility of the TAMBE
Device in the treatment of patients with aortic aneurysms involving the visceral branch
vessels. A maximum of 10 Subjects will be treated under this Protocol. This clinical study
will include up to six sites in the US. Each enrolled subject will undergo periodic follow-up
evaluations involving physical exams, contrast-enhanced computed tomography (CT) of chest,
abdomen and pelvis, creatinine measurement, abdominal ultrasound (optional) at specific,
protocol-defined intervals for a period of five years following the GORE® EXCLUDER®
Thoracoabdominal Branch Endoprosthesis impant.

Inclusion Criteria:

1. Aortic aneurysm involving the visceral vessels requiring treatment

2. Adequate access for TAMBE Device components

3. Appropriate aortic anatomy to receive the TAMBE Device

4. Age ≥ 18 years at the time of informed consent signature

5. Male or infertile female

6. The patient is considered high risk for open repair as deemed by the treating
physician

7. Capable of complying with protocol requirements, including follow-up

8. An Informed Consent Form signed by Subject or legal representative Note: Additional
Inclusion Criteria may apply

Exclusion Criteria:

1. Prior aortic surgery

2. Ruptured or leaking aortic aneurysm

3. Aneurysmal dilatation due to chronic aortic dissection

4. Infected aorta

5. Mycotic aneurysm

6. Life expectancy <2 years

7. Myocardial infarction or stroke within 6 weeks of treatment

8. Systemic infection which may increase risk of endovascular graft infection

9. Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome

10. Participation in another drug or medical device study within 1 year of study
enrollment

11. History of drug abuse, e.g. cocaine or amphetamine or alcohol, within 1 year of
treatment

12. Tortuous or stenotic iliac and / or femoral arteries and the inability to use a
conduit for vascular access

13. Known sensitivities or allergies to the device materials

14. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known
hypersensitivity to heparin

15. Patient has body habitus or other medical condition which prevents adequate
fluoroscopic and CT visualization of the aorta

16. Renal Insufficiency Note: Additional Exclusion Criteria may apply