Device Dossier
GORE® EXCLUDER® lliac Branch Endoprosthesis, Iliac Branch Component – Abdominal aortic aneurysm stent
Device Dossier for GORE® EXCLUDER® lliac Branch Endoprosthesis, Iliac Branch Component – Abdominal aortic aneurysm stent (Abdominal aortic aneurysm…
- GMDN category: Abdominal aortic aneurysm stent
Intended purpose
The GORE® EXCLUDER® Iliac Branch Component is a component of the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE) which 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 Iliac Branch Component is a component of the GORE® EXCLUDER® lliac Branch Endoprosthesis (IBE). The IBC is a bifurcated Iliac branch device with an external iliac leg and an internal iliac artery gate. The IBC is placed in the common iliac at a level that allows the gate of the IBC access to the internal iliac artery. It will treat external iliac artery diameters of 6.5– 13.5mm and is loaded onto a delivery catheter.