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

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