Vascular Intervention // Peripheral
Self-Expanding Stent System/0.035”/OTW
Thinner struts for low Chronic Outward Force (COF)2
Thinner struts and lower COF make a difference:*
- Lower risk of restenosis3
- Reduced vessel injury and inflammation4
- Faster endothelialization5
*As demonstrated in pre-clinical studies
1 mm stent oversizing at 90 days6
Long term safety and efficacy (12 month data)
Clinically proven even in calcified lesions (4EVER), total occlusions (TASC D) and in all-comers registry (BIOFLEX PEACE).*
*Clinical outcomes of Pulsar-18 can be used to illustrate clinical outcomes of Pulsar-35 due to identical stent platforms
**FTLR - Freedom from Target Lesion Revascularization; †PP - Primary Patency; ††A.L.L. - Average Lesion Length
Sufficient radial force for a long term vessel support, even in calcified lesions
After the treatment 2011 2016
(Courtesy of Prof. van den Berg)
Accurate stent deployment
Tri-axial delivery system
The outer shaft isolates the retractable shaft from friction caused by the introducer valve to ensure accurate stent deployment.
Easy release handle
One-handed stent release handle, ergonomically designed for a comfortable and stable handling.
Indicated for use in patients with atherosclerotic disease of the femoral and proximal popliteal arteries, in particular for the treatment of insufficient results after percutaneous transluminal angioplasty (PTA).*
|Recommended guide wire
||proBIO (Amorphous Silicon Carbide)|
||6 gold markers each end
||ø 5.0 - 7.0 mm; L: 30 - 200 mm
||6 F, hydrophobic coating
||90 and 135 cm
1 6.0 diameters. BIOTRONIK data on file;
2 6.0 mm diameters. Supera stent not possible to test due to its design and applied test method. BIOTRONIK data on file;
3 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;
5 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. BIOTRONIK data on file. 2010 Nov;6(5):630-7. Soucy N, Feygin J et al.;
6 Funovic M. Presented at LINC 2017; Astron Pulsar results can be used to illustrate the impact of oversizing on the vessel for Pulsar-18 stent due to the similarity in the Astron Pulsar and Pulsar-18 stent materials and designs;
7 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;
8 Lichtenberg M. Superficial Femoral Artery TASC D registry: 12-month effectiveness analysis of the Pulsar-18 SE nitinol stent in patients with critical limb ischemia. J Cardiovasc Surg (Torino). 2013 Aug; 54(4):433-9;
9 Nolte-Ernsting C. BIOFLEX Peace 12-month results. Presented at CIRSE 2017.
Leading competitors have been selected based on the PV Stent Revenue Market Shares EU, 2017 and PV Revenue Market Shares APAC 2015; (Source: Milennium Research Group Inc.). Latest SFA self expanding stents for each manufacturer; Supera is a registered trademark of the Abbott Group of Companies; Lifestent is a registered trademark of C.R. Bard; Zilver is a registered trademark of Cook Medical; EverFlex and Entrust are registered trademarks of the Medtronic Group of Companies; Innova is a registered trademark of Boston Scientific.
*Indication as per IFU.