Vascular Intervention // Peripheral
Self-Expanding Stent System/0.035”/OTW
Pulsar-35
140 μm thin struts
Clinically proven
Tri-axial delivery system
140 μm thin struts - thinner than the leading brands1
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
Clinically proven
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.
Pulsar-35
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).*
Technical Data
| Pulsar-35 Stent | |
|---|---|
| Catheter type | OTW |
| Recommended guide wire | 0.035" |
| Stent material | Nitinol |
| Strut thickness | 140 μm |
| Strut width | 85 μm |
| Stent coating | proBIO (Amorphous Silicon Carbide) |
| Stent markers | 6 gold markers each end |
| Sizes | ø 5.0 - 7.0 mm; L: 30 - 200 mm |
| Proximal shaft | 6 F, hydrophobic coating |
| Usable length | 90 and 135 cm |
Ordering Information
| 5.0 (6F) | 379878 | 379879 | 379880 | 379881 | 379917 | 379918 | 379919 | 379920 | 379921 | |||||
| 6.0 (6F) | 379883 | 379884 | 379885 | 379886 | 379922 | 379923 | 379924 | 379925 | 379926 | |||||
| 7.0 (6F) | 379888 | 379889 | 379890 | 379891 | 379927 | 379928 | 379929 | 379930 | 379931 | |||||
| 5.0 (6F) | 379898 | 379899 | 379900 | 379901 | 379937 | 379938 | 379939 | 379940 | 379941 | |||||
| 6.0 (6F) | 379903 | 379904 | 379905 | 379906 | 379942 | 379943 | 379944 | 379945 | 379946 | |||||
| 7.0 (6F) | 379908 | 379909 | 379910 | 379911 | 379947 | 379948 | 379949 | 379950 | 379951 | |||||
Contact
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;
4 Ibid.
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.