JOTEC E-liac Stent Graft System - HSA Registration DE0503780
Access comprehensive regulatory information for JOTEC E-liac Stent Graft System in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0503780 and owned by JOTEC GmbH. The device was registered on October 30, 2019.
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For endovascular treatment of patients with: •Unilateral or bilateral aorta-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 (6mm OD) 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