Device Dossier

E-tegra Stent Graft System – Aortic Extension - Abdominal aortic aneurysm stent

Device Dossier for E-tegra Stent Graft System – Aortic Extension - Abdominal aortic aneurysm stent (Abdominal aortic aneurysm stent, Class III, sponsor…

Intended purpose

The E-tegra Stent Graft System is indicated for the endovasculartreatment of infrarenal aortic aneurysms. These aneurysms can alsoaffect the common iliac artery.

Functional description

The E-tegra Stent Graft System consists of two main components:the E-tegra Stent Graft and the E-Tegra Delivery System, in which the E-tegra stent graft is loaded. The implants of the E-tegra Stent Graft System are self-expanding, endoluminal stent grafts remaining in the body after deployment. The bifurcation prosthesis and aorto-uni-iliac can be extended proximally with the aortic extension (AE). It has a cylindrical structure with a laser-cut stent with active fixation for anchoring.

TGA Public Summary