Device Dossier
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis - Descending thoracic aorta endovascular stent-graft
Device Dossier for GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis - Descending thoracic aorta endovascular stent-graft (Descending thoracic aorta…
- GMDN category: Descending thoracic aorta endovascular stent-graft
Intended purpose
The GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis is indicated for endovascular repair in patients with thoracoabdominal aortic aneurysms and high-surgical risk patients with pararenal aortic aneurysms who have appropriate anatomy as described below: 1.Adequate iliac/femoral access and brachial/axillary access 2.Proximal (supraceliac) aortic neck treatment diameter range over 2 cm seal zone of 22-34 mm for aneurysms extending up to 6.5 cm or less above the origin of the most proximal branch vessel 3.Aortic neck angle ≤ 60° at the Aortic Component proximal seal zone 4.Iliac artery treatment diameter range of 8-25 mm and iliac artery seal zone length of at least 10 mm 5.Renal artery seal zone diameters between 4.0-10.0 mm 6.Celiac and superior mesenteric artery seal zone diameters between 5.0-12.0 mm 7.≥ 15 mm seal zone length in renal arteries, superior mesenteric artery, and celiac artery 8.Visceral segment of aorta (3 cm proximal through 9.5 cm distal to the most proximal visceral artery) must be ≥ 20 mm in diameter