The Nellix® EndoVascular Aneurysm Sealing System for the Treatment of Infrarenal Abdominal Aortic Aneurysms

Exclusion Criteria

• •Life expectancy ≤ 1 year
• •Dissecting, ruptured, or leaking aneurysm (blood outside the aorta), has sustained recent trauma, is symptomatic, or is non-degenerative
• •Aneurysm is thoraco-abdominal, suprarenal and/or mycotic
• •Thoracic aneurysm ≥ 4.5cm in diameter
• •AAA requires treatment that would result in bilateral occlusion of the internal iliac arteries
• •Presence of mural thrombus \> 50% circumferentially in aortic neck
• •Iliac aneurysm blood lumen diameter \> 35mm
• •Active infection, vasculitis, or systemic connective tissue disease (e.g., Rheumatoid arthritis, scleroderma, Marfan's syndrome, Ehlers-Danlos disease) at time of procedure
• •History of prior treatment of abdominal aortic or iliac artery aneurysm disease
• •Femoral or iliac artery occlusive disease such that device delivery is not possible
• •Vascular access for delivery of device requires placement of vascular conduit or is through an established vascular graft
• •Receiving dialysis
• •History of hypercoagulability
• •Allergy to IV contrast
• •Serum creatinine level \>2.0 mg/dL (or equivalent)
• •Patient is pregnant or nursing
• •Patient is currently enrolled in an investigational drug or device trial