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US Device Guide / Balloon-Expandable Covered Stents

Company Name Product Name Material Used Maximum Guidewire Size (inch) Introducer Size (F) Stent Diameter (mm) Stent Length (mm) Delivery System Length (cm) US FDA Indicated Use
Getinge Atrium iCast Covered Stent 316L stainless steel 0.035 6, 7 5–10 16, 22, 38, 59 80, 120 Tracheobronchial
B. Braun Interventional Systems, Inc. CP Stent 0.035 12, 14, 16, 18 12–30 16, 22, 28, 34, 39, 45, 50, 55, 60 110 Coarctation of the aorta; RVOT conduit disruption
B. Braun Interventional Systems, Inc. CP Stent (Unmounted) 12–30 16, 22, 28, 34, 39, 45, 50, 55, 60 Coarctation of the aorta; RVOT conduit disruption
Gore & Associates Gore Viabahn VBX Balloon Expandable Endoprosthesis Stainless steel stent/fluoropolymer graft 0.035 7, 8 5, 6, 7, 8, 8L, 9, 10, 11 15, 19, 29, 39, 59, 79 80, 135 Treatment of de novo or restenotic lesions found in iliac arteries with reference vessel diameters ranging from 5–13 mm and lesion lengths ≤ 110 mm, including lesions at the aortic bifurcation
BD Interventional LifeStream Balloon Expandable Vascular Covered Stent 316L stainless steel and ePTFE 0.035 6, 7, 8 5, 6, 7, 8, 9, 10, 12 16, 26, 37/38, 58 80, 135 Indicated for the treatment of atherosclerotic lesions in common and external iliac arteries
B. Braun Interventional Systems, Inc. NuDEL CP Stent Delivery System 0.035 12, 14 12–24 16, 22, 28, 34, 39, 45 110 Coarctation of the aorta; RVOT conduit disruption

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