Stent Graft System - India CDSCO Medical Device Registration

Product Information

The E-liac Stent Graft System is indicated for the endovascular treatment of patients with the following characteristics: • Unilateral or bilateral aorto-iliac or iliac aneurysm • Suitable for endovascular repair • Patient must be compliant with life- long follow-up investigations • > 18 years old • Iliac/femoral access vessel morphology compatible with the implantation procedure and the 18F (E-liac) delivery system • Non-aneurysmal common iliac artery landing area in case of iliac artery aneurysm ≥ 20mm • Diameter of the common iliac artery in the proximal landing area: 12mm to 17mm • Non-aneurysmal external iliac artery segment distal to the aneurysm ≥ 15mm • Diameter of the external iliac artery in the distal landing area: 8mm to 13mm • Non-aneurysmal internal iliac artery segment distal to the aneurysm ≥ 15mm • Angle between external iliac artery and internal iliac artery ≤ 50° • Thrombus free iliac lumen in the area of iliac bifurcation to open side branch and to implant covered stent ≥ 18mm • Sufficiently open internal iliac artery ostium ,ePTFE Vascular Graft(E-liac)-The FlowLine Bipore ePTFE vascular graft is indicated in cases of arterial reconstruction, primarily in the peripheral vascular region. It can also be used in extraanatomical reconstructions – femorofemoral and axillofemoral. Standardwall FlowLine Bipore prosthesis are also indicated for use as arteriovenous shunt prosthesis in haemodialysis.