Zenith® Fenestrated AAA Endovascular Graft proximal body

The Zenith Fenestrated AAA Endovascular Graft with H&L-B One-Shot™ Introduction System is indicated for the treatment of infrarenal abdominal aneurysms (AAAs) in adults patients (≥18 years) with infrarenal abdominal aortic aneurysms who are not suitable for repair with a standard Zenith Endovascular Graft, when the aneurysmal disease extends up to the level of the renal arteries.  

The patient must have aneurysmal morphology suitable for endovascular repair, including:

• Adequate femoral/iliac access compatible with the required delivery systems;
• A non-aneurysmal infrarenal aortic segment (neck) proximal to the aneurysm with:
     ◦ A length of at least 4mm, i.e. at least 4 mm circumferential sealing zone below the lowest target vessel;
     ◦ A diameter measured outer wall to outer wall of no greater than 31 mm and no less than 19 mm;
     ◦ An angle less than 45 degrees relative to the long axis of the aneurysm; and
     ◦ An angle less than 45 degrees relative to the axis of the suprarenal aorta.
     ◦ An ipsilateral iliac artery distal fixation site greater than 10 mm in length and 9–21 mm in diameter (measured outer wall to outer wall); and
     ◦ A contralateral iliac artery distal fixation site greater than 10 mm in length and 7–21 mm in diameter (measured outer wall to outer wall).