Indicated for use to improve luminal diameter in patients with symptomatic de novo, restenotic or occlusive lesions located in the superficial femoral or proximal popliteal arteries, with reference vessel diameters from 3.0 to 6.0 mm and total lesion lengths up to 190 mm
1. Strut thickness for 6.0 mm diameters. Values reflect actual measurement and due to processing tolerances may not align to manufacturers statements. BIOTRONIK data on file; 2. Leading competitors have been selected based on the USA PV SFA Self-Expanding Stent Revenue Market Share, 2016; (Source: Millennium Research Group Inc.). Latest FDA approved SFA self-expanding stents for each manufacturer; 3. Chronic Outward Force for 6.0 mm diameters. Supera stent not possible to test due to its design and applied test method; 4. Bosiers M, et al. 4-French–Compatible Endovascular Material is Safe & Effective in the Treatment of Femoropopliteal Occlusive Disease: Results of the 4EVER Trial. J ENDOVASC THER. 2013; 20: 746-756; 5. 6.0 mm diameters. BIOTRONIK data on file; 6. As demonstrated in pre-clinical studies: Zhao HQ, Nikanorov A, Virmani R, Jones R, Schwartz LB. Late stent expansion and neointimal proliferation of oversized nitinol stents in peripheral arteries. Cardiovasc. Intervent. Radiol. 2009 Jul; 32(4); 720-6; 8. As demonstrated in pre-clinical studies: Konstantinos C. Role of Endothelial Shear Stress in Stent Restenosis and Thrombosis. JACC 2012.; Koppara et al. Circ Cardiovasc Interv 2015; 8: e002427.; EuroIntervention. 2010 Nov;6(5):630-7. Soucy N, Feygin J et al.; 9. As demonstrated in pre-clinical studies: Freeman JW, Snowhill PB, Nosher JL. A link between stent radial forces and vascular wall remodeling: the discovery of an optimal stent radial force for minimal vessel restenosis. Connect Tissue Res. 2010 Aug; 51(4): 314-26; Ballyk PD. Intramural stress increases exponentially with stent diameter: a stress threshold for neointimal hyperplasia. J Vasc Interv Radiol. 2006 Jul;17(7):1139-45; 9 BIOFLEX-I: P160025, www.fda.gov; 10 TASC D: Lichtenberg M, J Endovasc Ther. 2014, 21:373-380; 11. PEACE: Lichtenberg M, J Endovasc Ther. 2013; 20: 746–756; 12 Less access site complications than 6F - If no closure device is used.
Supera is a trademark of the Abbott Group of Companies; Lifestent is a registered trademark of C.R. Bard Inc.; Zilver is a registered trademark of Cook Medical Technologies LLC; Everflex is a registered trademark of Covidien LP/ev3 Endovascular Inc.; Complete is a registered trademark of Medtronic Vascular Inc.; Innova is a registered trademark of Boston Scientific Scimed Inc. Information on devices manufactured at companies other than BIOTRONIK was gathered from multiple sources. However it has not been verified by the vendors and we cannot guarantee its accuracy.
Information on devices manufactured at companies other than BIOTRONIK was gathered from multiple sources. However it has not been verified by the vendors and we cannot guarantee its accuracy.