Device Dossier
Gore Viabahn Endoprosthesis with Propaten Bioactive Surface - Multiple peripheral arteries stent
Device Dossier for Gore Viabahn Endoprosthesis with Propaten Bioactive Surface - Multiple peripheral arteries stent (Multiple peripheral arteries stent,…
- GMDN category: Multiple peripheral arteries stent
Intended purpose
The GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface is indicated for the treatment of:; -de novo or restenotic lesions in the iliac arteries; -de novo or restenotic lesions in the superficial femoral artery and proximal popliteal artery; -in-stent restenotic lesions in the superficial femoral artery and proximal popliteal artery; -stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (AV) access grafts and in the venous outflow of dialysis access circuits, including the central veins; -popliteal artery aneurysms and isolated visceral artery aneurysms; -traumatic or iatrogenic vessel injuries in arteries that are located in the chest cavity, abdominal cavity, or pelvis (except for aorta, coronary, innominate, carotid, vertebral, and pulmonary arteries)
Functional description
A self expanding endoluminal endoprosthesis with an ePTFE lining and external nitinol support. Its surface is modified with covalently bound bioactive heparin. It is provided compressed and attached to a dual lumen delivery catheter. The larger central catheter lumen is used for flushing and guidewire introduction. The smaller lumen contains elements of the deployment mechanism. 2 radiopaque bands are attached to the catheter shaft, marking the ends of the compressed endoprosthesis