BIOTRONIK US Announces Pivotal Trial Results of the Pulsar-18 Stent with 4-French Delivery System

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

References:

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.