Device Dossier

GORE® EXCLUDER® lliac Branch Endoprosthesis, Internal Iliac Component - Abdominal aortic aneurysm stent

Device Dossier for GORE® EXCLUDER® lliac Branch Endoprosthesis, Internal Iliac Component - Abdominal aortic aneurysm stent (Abdominal aortic aneurysm…

Intended purpose

The GORE® EXCLUDER® Internal Iliac Component is a component of the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE). The GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE) is intended to isolate the common iliac artery from systemic blood flow and preserve blood flow in the external iliac and internal iliac arteries in patients with an iliac or aortoiliac aneurysm, who have appropriate anatomy, including: 1. Adequate iliac / femoral access 2. Minimum common iliac diameter of 17 mm at the proximal implantation zone of the IBE 3. External Iliac artery treatment diameter range of 6.5 –25 mm and seal zone length of at least 10 mm 4. Internal iliac artery treatment diameter range of 6.5 –13.5 mm and seal zone length of at least 10 mm

Functional description

The Internal Iliac Component (IIC) is a component of the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE). The IIC is loaded onto a delivery catheter and is used to extend into the internal iliac artery.

TGA Public Summary