EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study

This study will evaluate the safety and effectiveness of the Nellix System among a wide range
of physicians and in consecutively enrolled subjects to assess safety and effectiveness
outcomes. Following appropriate government and ethics committee/IRB approval the Nellix®
EndoVascular Sealing System will be implanted into eligible patients who are adequately
informed and have consented to join the study. Enrolled patients will undergo a high
resolution, contrast-enhanced computed tomography angiography (CT) scan of the relevant
aortic and aortoiliac vasculature within three months of the scheduled procedure and at
specified follow-up intervals post-implantation. Follow-up visits will occur at 30 days, 6
months, and annually to 5 years to assess aneurysm morphology, the status of the implanted
devices, and relevant laboratory test results.

INCLUSION CRITERIA

A patient who meets all of the following criteria potentially may be included in the study:

1. Male or female at least 18 years old;

2. Informed consent form understood and signed

3. Patient agrees to all follow-up visits;

4. Abdominal aortic aneurysm with sac diameter ≥5.0cm, or ≥4.5cm which has increased by
≥0.5cm within the last 6 months, or or which exceeds 1.5 times the transverse
dimension of an adjacent non-aneurysmal aortic segment. No AAA <4 cm will be included.

5. Anatomically eligible for the Nellix System (per Instructions For Use):

1. Adequate iliac/femoral access compatible with the required delivery systems
(diameter ≥6 mm);

2. Aneurysm blood lumen diameter ≤60mm;

3. Proximal non-aneurysmal aortic neck: length ≥10mm; diameter 18 to 28mm; angle
≤60° to the aneurysm sac;

4. Most caudal renal artery to each hypogastric artery length ≥100mm;

5. Common iliac artery lumen diameter between 9 and 35mm;

6. Distal iliac artery seal zone with length of ≥10mm and diameter range of 9 to
25mm;

7. Ability to preserve at least one hypogastric artery.

8. Ratio of maximum aortic aneurysm diameter to maximum aortic blood lumen diameter
<1.40

EXCLUSION CRITERIA

A patient who meets none of the following criteria potentially may be included in the
study:

1. Life expectancy <2 years as judged by the Investigator;

2. Psychiatric or other condition that may interfere with the study;

3. Participating in another clinical study;

4. Known allergy or contraindication to any device material;

5. Coagulopathy or uncontrolled bleeding disorder;

6. Ruptured, leaking or mycotic aneurysm;

7. Serum creatinine (S-Cr) level >2.0 mg/dL;

8. CVA or MI within three months of enrollment/treatment;

9. Aneurysmal disease of the descending thoracic aorta;

10. Clinically significant mural thrombus within the proximal landing zone (minimum 10mm)
of the infrarenal non-aneurysmal neck (>5mm thickness over >50% circumference);

11. Connective tissue diseases (e.g., Marfan Syndrome);

12. Unsuitable vascular anatomy that may interfere with device introduction or deployment;

13. Pregnant (female of childbearing potential only).