Pulsar-18

 
 
 

Vascular Intervention // Peripheral
Self-Expanding Stent System/0.018''/OTW

Pulsar ®-18


   140 μm thin struts

   4F low profile

   Clinically proven

 

 

 

 



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)
** 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





Exceptional clinical outcomes (12 month data)






Results from different trials are not directly comparable. Differences in outcomes may be the result of differences in protocol design, patient populations or other factors.

*Bail out group


Stent designed for SFA*

Multi-directional flexibility to conform to the natural vessel movement.

*Superficial Femoral Artery


Elongation


Low axial stiffness for high flexibility16




Bending


Peak-to-valley design and S-articulating connecting bars provide multi-directional flexibility and avoid fish scaling inmobile vessel architecture.17







4F Low Profile - Improved acute outcomes vs. 6F7


Potential for safer, faster and simpler procedures than 6F

 

  • Clinically proven lower access site complication rates7
  • Shorter compression time7
  • 45% smaller puncture site area than 6F18
  • No need for a closure device

 

 


Stent deployment


One-handed stent release handle, ergonomically designed for a comfortable and stable handling.

 

 

 

 

 


 

 

 

 

 

Pulsar-18

 


Indicated for use in patients with atherosclerotic disease of the femoral and infrapopliteal arteries and for the treatment of insufficient results after percutaneous transluminal angioplasty.*

 

 

 

 

 

 

 

 

 

 
 
 
 
 
 

Technical Data

 
Pulsar-18 Stent
Catheter type OTW
Recommended guide wire 0.018"
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 4.0 - 7.0 mm; L: 204 - 200 mm
Proximal shaft 3.6 F, hydrophobic coating
Usable length 90 and 135 cm
 

Ordering Information

 
       
4.0 (4F)   377456 377457 377458 377459 377460 366808 366809 366810 366811 366812
5.0 (4F)   377461 377462 377463 377464 377465 366813 366814 366815 366816 366817
6.0 (4F)   377466 377467 377468 377469 377470 366818 366819 366820 366821 366822
7.0 (4F)   377471 377472 377473 377474 377475 366823 366824 366825 366826 366827
 
       
4.0 (4F)   377476 377477 377478 377479 377480 366828 366829 366830 366831 366832
5.0 (4F)   377481 377482 377483 377484 377485 366833 366834 366835 366836 366837
6.0 (4F)   377486 377487 377488 377489 377490 366838 366839 366840 366841 366842
7.0 (4F)   377491 377492 377493 377494 377495 366843 366844 366845 366846 366847
 
 
 
 

Contact

contact
Country/Region

1 6.0 mm 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 Late stent expansion and neointimal proliferation of oversized nitinol stents in peripheral arteries. Cardiovasc. Interv. Radiol. 2009 Jul; 32(4); 720-6;

4 As demonstrated in pre-clinical studies: Zhao HQ Late stent expansion and neointimal proliferation of oversized nitinol stents in peripheral arteries. Cardiovasc. Interv. 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; Soucy N. Strut tissue coverage and endothelial cell coverage: a comparison between bare metal stent platforms and platinum chromium stents with and without everolimus-eluting coating. EuroIntervention 2010;6:630-637;

6 Funovic M. Presented at LINC 2017; Astron Pulsar results can be used to illustrate the impact of over sizing 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;

10 Nolte-Ernsting C. BIOFLEX Peace 12-month results. Presented at CIRSE 2017;

11 Laird JR. Nitinol stent implantation versus balloon angioplasty for lesions in the Superficial Femoral Artery and Proximal Popliteal Artery. 12-month Results From the RESILIENT randomized trial (stent group). Circ Cardiovasc Interv. 2010; 3(3):267-76;

12 Supera SSED. US Food and Drug Administration, Center for Devices and Radiological Health. Supera® Peripheral Stent System P120020;

13 SuperNOVA. US Food and Drug Administration, Center for Devices and Radiological Health, Innova™ Vascular Self-Expanding Stent System P140028;

14 Dake M. Paclitaxel-Eluting Stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease. 12-month Zilver PTX randomized study results. Circ Cardiovasc Interv. 2011; 4:495-504;

15 Bosiers M. Nitinol stent implantation in long Superficial Femoral Artery Lesions: 12-month results of the DURABILITY I Study. J ENDOVASC THER 2009; 16:261–269;

16 BIOTRONIK data on file;

17 BIOTRONIK data on file;

18 BIOTRONIK data on file.
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.