GORE EXCLUDER AAA Trunk-Ipsilateral Leg Endoprosthesis - Prosthesis, internal, stent, vascular

Intended purpose

The GORE® EXCLUDER® 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 19 – 32mm and a minimum aortic neck length of 15mm • Proximal aortic neck angulation ≤ 60° • Iliac artery treatment diameter range of 8 - 25mm and iliac distal vessel seal zone length of at least 10mm The Aortic and Iliac Extender Endoprostheses are intended to be used after deployment of the GORE® EXCLUDER® AAA Endoprosthesis. These extensions are intended to be used when additional length and/or sealing for aneurysmal exclusion is desired

Functional description

Trunk-Ipsilateral Leg Endoprostheses consists of ePTFE and FEP, supported by nitinol wire along its external surface. Nitinol anchors and an ePTFE/FEP sealing cuff are located at the aortic end of the trunk. An ePTFE sleeve is used to constrain the endoprostheses on the leading edge of the delivery catheter. Deployment is initiated from the leading (aortic) end and proceeds toward the trailing (iliac) end of the delivery catheter, which is supplied with the endoprosthesis.