Zenith Alpha Abdominal Endovascular Graft - Main Body - Graft, vascular, synthetic

Intended purpose

The Zenith Alpha Abdominal Endovascular Graft is indicated for the endovascular treatment of patients with abdominal aortic or aorta-iliac aneurysms having morphology suitable for endovascular repair, inluding: a) Iliofemoral access vessel size and morphology (minimal thrombus, calcification and/or tortuosity) should be compatible with a 16 French (6.0 mm OD) or 17 French (6.5 mm OD) vascular introducer sheath; b) Non-aneurysmal infrarenal aortic segment (neck) proximal to the aneurysm: - With a length of at least 15 mm, - With a diameter measured outer wall to outer wall of no greater than 32 mm and no less than 18mm, - With and angle less than 60 degrees relative to the long axis of the aneurysm, and - With and angle less than 45 degrees relative to the axis of the suprarenal aorta. c) Iliac artery distal fixation site greater than 10 mm in length and 8 to 20 mm in diameter (measured outer wall to outer wall).

Functional description

This device is part of a modular system consisting of a Main Body, two Iliac Legs, Main Body Extension and a Converter. The graft modules are constructed of woven polyester fabric sewn to self-expanding nitinol stents with braided polyester and monofilament polypropelene suture. The modules are fully stented to provide stability and the expansile force necessary to open the lumen of the graft during deployment. The stents provide the necessary attachment and seal of the graft to the vessel wall.