LINC 2019: BIOTRONIK Introduces the First Tri-axial 4-French Low-Profile Stent System

BIOTRONIK presented the innovative Pulsar-18 T3 stent system for the first time during LINC 2019 in Leipzig this week.

The Pulsar-18 T3 system is a unique combination of three technologies for an improved implantation procedure. The 4-French low profile decreases the risk of access site complications¹ and reduces the need for closure devices compared to 6-French, while the tri-axial shaft design facilitates stable and accurate implantation of the clinically proven Pulsar stent. The intuitive and ergonomic wheel-operated handle simplifies handling during the procedure for physicians.

The superficial femoral artery (SFA) requires a stent that conforms to the natural vessel movement and provides sufficient support in complex and long lesions. The new device unifies proven technologies for efficient delivery of stents up to 200 mm to the challenging SFA. The thin struts, low chronic outward force (COF) and high multidirectional flexibility of the Pulsar stent ensure conformability and support to the vessel in all natural vessel movements.

“Pulsar-18 T3 is a unique innovation; this is the first time physicians have access to a self-expanding stent system that combines the benefits of 4-French with the accurate deployment of a tri-axial system,” stated Dr. Alexander Uhl, Senior Vice President Corporate Marketing at BIOTRONIK. “Pulsar-18 T3 represents BIOTRONIK’s dedication to providing effective therapies which minimize burden and reduce risks to patients.”

References

^{1. Bosiers M. 4EVER JEVT 2013;20:746-756.}

^{2. Lichtenberg M. BIOFLEX PEACE registry: 12 and 24 month results. Presented at:LINC, Jan 31, 2018; Leipzig, Germany.}

^{3. Bosiers M, et al. 4-French -compatible endovascular material is safe & effective in the treatment of femoropopliteal occlusive disease: Results of the 4EVER Trial. ENDOVASC THER 2013; 20: 746-756.}

^{4. BIOTRONIK data on file.}

^{5. As demonstrated in pre-clinical studies: Zhao HQ, et al. Late stent expansion and neointimal proliferation of oversized nitinol stents in peripheral arteries. Cardiovasc Intervent Radiol. 2009 Jul; 32(4); 720-6.}

^{6. 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.}

^{7. As demonstrated in pre-clinical studies: Freeman JW, et al. 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, et al. Late stent expansion and neointimal proliferation of oversized nitinol stents in peripheral arteries. Cardiovasc Intervent Radiol. 2009 Jul; 32(4): 720-6.}