INDICATIONS FOR USE: The TriVascular Ovation Abdominal Stent Graft System is indicated for use in subjects diagnosed with an aneurysm in the abdominal aorta with small aortic diameters and access vessels of less than 7 mm in diameter, having vascular morphology suitable for endovascular repair, including: adequate iliac/femoral access compatible with vascular access techniques, devices, and/or accessories; a non-aneurysmal proximal aortic neck with a length of at least 7 mm proximal to the aneurysm, with an inner wall diameter of no less than 15.5 mm and no greater than 17.4 mm, and with an aortic angle of d 60 degrees if proximal neck is > 10 mm and < 45 degrees if proximal neck is < 10 mm; adequate distal iliac landing zone with a length of at least 10 mm, with an inner wall diameter of no less than 8 mm and no greater than 17 mm.

CONTRAINDICATIONS: The TriVascular Ovation Abdominal Stent Graft System is contraindicated indicated for use in patients who have a condition that threatens to infect the graft and patients with sensitivities or allergies to the device materials. Also consider the information in Section 4 Warnings and Precautions of the systems Instructions for Use.

Refer to Instructions for Use at TriVascular.com for more information concerning Indications, Contraindications, Warnings and Precautions, and Adverse Events.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

HUMANITARIAN DEVICE Authorized by Federal law for use in the treatment of abdominal aortic aneurysms. The effectiveness of this device for this use has not been demonstrated.