Device Dossier
Zenith Fenestrated AAA Endovascular Graft - Abdominal aortic aneurysm stent
Device Dossier for Zenith Fenestrated AAA Endovascular Graft - Abdominal aortic aneurysm stent (Abdominal aortic aneurysm stent, Class III, sponsor…
- GMDN category: Abdominal aortic aneurysm stent
Intended purpose
The Zenith Fenestrated AAA Endovascular Graft with the H&L-B One-Shot Introduction System is intended to provide an intravascular conduit that excludes an abdominal aortic aneurysm from blood flow while maintaining distal perfusion.
Functional description
This modular system self-expands stainless steel stents with braided polyester and monofilament polypropylene suture. Each individual device has its own separate delivery system. The bare suprarenal stent of the proximal body graft contains barbs for additional fixation. The scallops and fenestrations is to allow the proximal margin to sit higher and allow uninterrupted blood flow to branch vessels of the aorta. Radiopaque markers on the graft are to facilitate fluoroscopic visualisation.