Pulsar-18 T3 Self-Expanding Stent Designed for More Effective Lesion Treatment in the Superficial Femoral, Proximal Popliteal and Infrapopliteal Arteries up to 200 mm

LEIPZIG, Germany and BUELACH, Switzerland, January 22, 2019 – 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.”

A New Delivery System for Clinically Proven Technology

While introducing the new features to enhance deployment, the new stent system builds on the established Pulsar-18 stent. Recent data highlighted the long term safety and efficiency of Pulsar-18 by showing a freedom from target lesion revascularization rate of 92.4% at 24 months.²

The 4-French delivery system offers a number of benefits, including clinically proven lower access site complication rates and a reduced need for closure devices compared to 6-French stents.³ With its low COF⁴ and thin struts of 140 µm, Pulsar-18 is proven to cause less vessel injury and inflammation⁵, provide faster endothelialization⁶ and lower the risk of restenosis.⁷

Pulsar-18 T3 is indicated for use in patients with atherosclerotic disease of the superficial femoral, proximal popliteal and infrapopliteal arteries and for the treatment of insufficient results after percutaneous transluminal angioplasty (PTA), e.g. residual stenosis and dissection.

About BIOTRONIK

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.

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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.