Stent Graft System
- UID
- IMP/MD/2019/000451_4e1501c99ce27b28129b025c3e7fdcf9_d0a0e23133a64bb04c659d07bd15d9c9
- Device class
- Class C
- Brand name
- E-liac
- License holder
- Vibgyor Health Care Pvt. Ltd.
- Approving authority
- CDSCO
- 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.
Stent Graft System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000451_4e1501c99ce27b28129b025c3e7fdcf9_d0a0e23133a64bb04c659d07bd15d9c9. This device is marketed under the brand name E-liac. The license holder is Vibgyor Health Care Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.
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