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)379878379879379880379881379917379918379919379920379921
6.0 (6F)379883379884379885379886379922379923379924379925379926
7.0 (6F)379888379889379890379891379927379928379929379930379931
5.0 (6F)379898379899379900379901379937379938379939379940379941
6.0 (6F)379903379904379905379906379942379943379944379945379946
7.0 (6F)379908379909379910379911379947379948379949379950379951

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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.