BIOTRONIK US Announces Pivotal Trial Results of the Pulsar-18 Stent with 4-French Delivery System
BIOFLEX-I Clinical Study Proves Efficacy of Self-Expanding Stent with 87.6 Percent Freedom from Clinically-Driven TLR
BIOTRONIK today announced the results of the BIOFLEX-I clinical study and availability of Pulsar-18 for the treatment of patients with peripheral artery disease (PAD).
Pulsar-18 is the only superficial femoral artery (SFA) self-expanding stent approved by the FDA with a 4-French (4F) delivery system, enabling simpler, safer and more efficient procedures than larger diameter delivery systems. Procedure times are reduced because the 4F system more easily crosses lesions,1 lowers access site complication rates and requires less compression time without the need for a closure device.2
1 6.0 mm diameters. BIOTRONIK data on file.
2 Bosiers, Marc MD, et al. 4-French–Compatible Endovascular Material Is Safe and Effective in the Treatment of Femoropopliteal Occlusive Disease: Results of the 4-EVER Trial ENDOVASC THER 2013;20:746–756.
3 Major adverse events defined as a composite of procedure or stent-related death, target lesion revascularization, or target limb amputation.
4 Primary patency defined as a PSVR <2.4 on duplex ultrasound and confirmed by the Core Laboratory.
5 Strut thickness for 6.0 mm diameters. 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. Supera stent not possible to test due to its design and applied test method. 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.
7 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.
8 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; Zhao HQ, Nikanorov A, Virmani R, Jones R, Pacheco E, Schwartz LB. Late stent expansion and neointimal proliferation of oversized nitinol stents in peripheral arteries. Cardiovasc Intervent Radiol. 2009 Jul; 32(4): 720-6.
9 Not currently available in the United States.
10 CAUTION – Investigational device. Limited by United States law to investigational use.
BIOTRONIK is a leading medical device company that has been developing trusted and innovative cardiovascular and endovascular solutions for more than 50 years. Driven by a purpose to perfectly match technology with the human body, BIOTRONIK innovations deliver care that saves and improves the lives of millions diagnosed with heart and blood vessel diseases every year. BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries.