Endovascular Stent Grafts - India CDSCO Medical Device Registration

Product Information

The Zenith Fenestrated AAA Endovascular Graft with the H&L-B One-Shot Introduction System is indicated for the treatment of infrarenal abdominal aortic aneurysms (Zenith Fenestrated AAA Endovascular Graft) in high- risk patients who are not suitable for conventional open surgical repair or 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 (Zenith Fenestrated AAA Endovascular Graft) proximal to the aneurysm with: - A length of at least 4 mm, i.e. at least 4 mm circumferential wall contact around fenestrations and/or limits of scallop; - 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 (Zenith Fenestrated AAA Endovascular Graft); and A contralateral iliac artery distal fixation site greater than 10 mm in length and 7–21 mm in diameter (Zenith Fenestrated AAA Endovascular Graft).