Device Dossier

Zenith Spiral-Z AAA Iliac Leg with the Z-Trak Introduction System - Graft, vascular, synthetic

Device Dossier for Zenith Spiral-Z AAA Iliac Leg with the Z-Trak Introduction System - Graft, vascular, synthetic (Graft, vascular, synthetic, Class III,…

Intended purpose

The Zenith Spiral-Z AAA Iliac Leg with Z-Trak Introduction System is indicated for use with the Zenith AAA Endovascular Graft family of products during either a primary or a secondary procedure in patients who have adequate iliac/femoral access compatible with the required introduction systems. The graft is used in combination with these products for the endovascular treatment of aortic and aorto-iliac aneurysms.

Functional description

The Spiral-Z is a leg extension that is intended to be placed with a Zenith AAA Endovascular Stent Graft main body. The leg extension is placed in an iliac artery, while the main body is situated in the aorta. The Spiral-Z is placed percutaneously via the femoral artery using the Z-Trak Introduction System. Following placement a moulding balloon is used to ensure proper fit. Angiographies are performed both prior to and following the procedure.

TGA Public Summary