Device Dossier
Zenith Alpha Spiral-Z Endovascular Leg - Graft, vascular, synthetic
Device Dossier for Zenith Alpha Spiral-Z Endovascular Leg - Graft, vascular, synthetic (Graft, vascular, synthetic, Class III, sponsor William A Cook).…
- GMDN category: Graft, vascular, synthetic
Intended purpose
The Zenith Alpha Spiral-Z Endovascular Leg is indicated for use with the Zenith AAA Endovascular Graft family of products, including the Zenith Alpha Abdominal Endovascular Graft, Zenith Low Profile AAA Endovascular Graft, Zenith Flex AAA Endovascular Graft, Zenith Renu AAA Ancillary Graft, Flex AUI, Zenith Fenestrated AAA Endovascular Graft, Zenith Branch Iliac Endovascular Graft, and Zenith AAA Ancillary Components, during either a primary or 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 abdominal aortic and aorta-iliac aneurysms.
Functional description
This device is part of a modular system typically consisting of a bifurcated main body and two iliac legs. It is constructed of woven polyester fabric sewn to five self-expanding nitinol Z-stents and a continuous nitinol spiral stent with braided polyester and monofilament polypropylene suture. The graft is fully stented to provide stability and the expansile force necessary to open the lumen of the graft during deployment. Z-stents provide the necessary attachment/seal of the graft to the wall.