Device Dossier
GORE® EXCLUDER® Conformable AAA Trunk-Ipsilateral Leg Endoprosthesis - Abdominal aortic aneurysm stent
Device Dossier for GORE® EXCLUDER® Conformable AAA Trunk-Ipsilateral Leg Endoprosthesis - Abdominal aortic aneurysm stent (Abdominal aortic aneurysm…
- GMDN category: Abdominal aortic aneurysm stent
Intended purpose
The GORE® EXCLUDER® Conformable AAA Endoprosthesis is intended to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysm (AAA) disease and who have appropriate anatomy as described below: • Adequate iliac / femoral access • Infrarenal aortic neck treatment diameter range of 16–32 mm • A minimum aortic neck length of 10 mm when proximal aortic neck angulation is less than or equal to 60 degrees • A minimum aortic neck length of 15 mm when proximal aortic neck angulation is less than or equal to 90 degrees • Iliac artery treatment diameter range of 8–25 mm and iliac distal vessel seal zone length of at least 10 mm
Functional description
The GORE® EXCLUDER® Conformable AAA Endoprosthesis is a single-use, permanently implanted device for the treatment of abdominal aortic aneurysm (AAA), an enlargement of the aorta caused by a weakening of the artery wall. The GORE® EXCLUDER® Conformable AAA Endoprosthesis may be used to accommodate specific anatomy of an aneurysm.