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US Device Guide / Self-Expanding Stent Grafts

Company Name Product Name Materials Used Introducer Size (F) Guidewire Compatibility (inch) Stent Diameter (mm) Stent Length (mm) Delivery System Length (cm) US FDA Indicated Use Comments
BD Interventional Covera Vascular Covered Stent Nitinol/ePTFE 8, 9 0.035 6, 7, 8, 9, 10 30, 40, 60, 80, 100 80, 120 Indicated for use in hemodialysis patients for the treatment of stenoses in the venous outflow of an AV fistula and at the venous anastomosis of ePTFE or other synthetic AV grafts
BD Interventional Flair Endovascular Stent Graft Nitinol/ePTFE 9 0.035 6, 7, 8,* 9* 30, 40, 50, 70 80 Indicated for use in the treatment of stenoses at venous anastomosis of ePTFE or other synthetic AV grafts *8-, 9-mm diameter not available on 70-mm length
BD Interventional Fluency Plus Endovascular Stent Graft Nitinol/ePTFE 8, 9, 10 0.035 6, 7, 8, 9, 10, 12, 13.5 40, 60, 80, 100, 120 80, 117 Indicated for use in the treatment of in-stent restenosis in the venous outflow of hemodialysis patients dialyzing by either an AVF or AV graft and for the treatment of stenosis in the venous outflow of hemodialysis patients dialyzing by an AV graft
Gore & Associates Gore Viabahn Endoprosthesis Nitinol/ePTFE, gold 7–12 0.035 5, 6, 7, 8, 9, 10, 11, 13 25, 50, 100, 150 75, 120 5–7 mm indicated for in-stent restenosis lesions in SFA up to 270 mm in length; 5–8 mm indicated for SFA lesions up to 270 mm in length; 5–13 mm indicated for iliac artery lesions up to 80 mm in length; also indicated for stenosis or thrombotic occlusion at venous anastomosis of AV access grafts
Gore & Associates Gore Viabahn Endoprosthesis With Heparin Bioactive Surface Nitinol/ePTFE, gold 6–12 0.018/0.014 (5–8 mm), 0.035 (5–13 mm) 5, 6, 7, 8, 9, 10, 11, 13 25, 50, 75, 100, 150, 250 75 (0.035-inch system only), 120 5–7 mm indicated for in-stent restenosis lesions in SFA up to 270 mm in length; 5–8 mm indicated for SFA lesions up to 270 mm in length; 5–13 mm indicated for iliac artery lesions up to 80 mm in length; also indicated for stenosis or thrombotic occlusion at venous anastomosis of AV access grafts
Gore & Associates Gore Viabil Biliary Endoprosthesis Nitinol/ePTFE 10 (percutaneous) 0.035 8, 10 40, 60, 80, 100 40 (percutaneous) Malignant biliary strictures* *Contraindicated for all cardiovascular applications
Gore & Associates Gore Viatorr TIPS Endoprosthesis with Controlled Expansion Nitinol/ePTFE 10 ≤ 0.035 8–10 60, 70, 80, 90, 100 75 Indicated for use in de novo and revision treatment of portal hypertension and its complications such as variceal bleeding, gastropathy, ascites, and/or hepatic hydrothorax TIPS, transjugular intrahepatic portosystemic shunt

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