Pulsar®-18

    Clinically proven thin struts stent on a 4F profile

    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(PTA).*

    Categoria

    Vascular Intervention Peripheral Stent Systems

    Product Highlights

    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 inflammation3

    • Faster endothelialization4, 5

    Stent designed for SFA*: multi-directional flexibility to conform to the natural vessel movement

    *Superficial Femoral Artery

    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 6F8

    • No need for a closure device7

    • Potential for ambulatory treatment

    One-handed stent release handle with easy release system, ergonomically designed for a comfortable and stable handling

    Easy release

    Relieves friction of introducer valve on the retractable shaft during stent deployment, providing a smoother action. 

    Clinically proven

    Long term safety and efficacy (24-month data), even in calcified lesions

    Safe and effective at 12 months

    Sufficient radial force for a long term vessel support, even in calcified lesions

    24-month outcomes of Pulsar, highlighting the long term safety and efficacy

    Technical Data

    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:20 - 200 mm
    Proximal shaft 3.6F, hydrophobic coating
    Usable length 90 cm and 135 cm

    Ordering Information

      Stent

    ø(mm)    		 Catheter length 90 cm

    (Stent length mm)
        20** 30 40 60 80 100 120 150 170 200
    4F 4.0 377456 377457 377458 377459 377460 366808 366809 366810 366811 366812
    5.0 377461 377462 377463 377464 377465 366813 366814 366815 366816 366817
    6.0 377466 377467 377468 377469 377470 366818 366819 366820 366821 366822
    7.0 377471 377472 377473 377474 377475 366823 366824 366825 366826 366827
    **8 weeks pre-order only
      Stent

    ø(mm)    		 Catheter length 135 cm

    (Stent length mm)
    4F   20** 30 40 60 80 100 120 150 170 200
    4.0 377476 377477 377478 377479 377480 366828 366829 366830 366831 366832
    5.0 377481 377482 377483 377484 377485 366833 366834 366835 366836 366837
    6.0 377486 377487 377488 377489 377490 366838 366839 366840 366841 366842
    7.0 377491 377492 377493 377494 377495 366843 366844 366845 366846 366847
    **8 weeks pre-order only

    Downloads and Related Links

    Downloads

    Download Brochure

    Related Links

    Newsroom Pulsar-18 T3 - Self-Expanding Stent System More information about Pulsar-18 T3 Passeo-18 Lux Drug-Coated Balloon

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    References

    *Indication as per IFU.

    1. BIOTRONIK data on file. 6.0 mm diameters; 2. BIOTRONIK data on file. 6.0 mm diameters. Supera stent not possible to test due to its design and applied test method; 3. Zhao HQ Late stent expansion and neointimal proliferation of oversized nitinol stents in peripheral arteries. Cardiovasc. Interv. Radiol. 2009; 32(4); 720-6; 4. Koskinas C. Role of endothelial shear stress in stent restenosis and thrombosis: pathophysiologic mechanisms and implications for clinical translation. JACC 2012 10;59(15):1337-49; 5. Koppara T. Thrombogenicity and early vascular healing response in metallic biodegradable polymer-based and fully bioabsorbable drug-eluting stents. Circ Cardiovasc Interv. 2015 8(6):e002427; 6. Funovics M. Correlation between chronic outward force (COF) and neointimal hyperplasia in self-expanding nitinol stents in swine in clinically relevant oversizing ranges. Presented at: LINC, Jan 26, 2017; Leipzig, Germany; 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. BIOTRONIK data on file; 9. 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 ; 54(4):433-9; 10. Lichtenberg et al. Effectiveness of the Pulsar-18 self-expanding stent with optional drug-coated balloon angioplasty in the treatment of femoropopliteal lesions - the BIOFLEX PEACE All-Comers Registry.Vasa (2019), 1-9. doi_10.10240301-1526a000785; 11. Supera IFU, EL2100430 (2016-03-23); 12. Bosiers M. 4EVER 24 month results: long-term results of 4F Pulsar stent in femoropopliteal lesions. Presented at: CIRSE 2013; Barcelona, Spain; 13. Rocha-Singh et al. DURABILITY II Three-Year Follow-up. Catheterization and Cardiovascular Interventions 2015; 86:164-170.

    Leading competitors have been selected based on the PV Stent Revenue Market Shares EU, 2017 and PV Revenue Market Shares APAC 2015; (Source: Millennium Research Group Inc.).

    Pulsar and proBIO are trademarks or registered trademarks of the BIOTRONIK Group of Companies. All other trademarks are the property of their respective owners.