Pulsar-35

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

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6 + 7 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.

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.