Pulsar®-35

    Clinically proven thin struts stent with tri-axial delivery system

    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), e.g. residual stenosis and dissection.*

    Catégorie

    Vascular Intervention Peripheral Stent Systems

    Product Highlights

    140 μm thin struts

    Clinically proven

    Tri-axial delivery system

    140 μm thin struts

    Pulsar-35 struts are thinner than the leading brands.1

    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

    Clinically proven

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

    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

    Accurate stent deployment

    Tri-axial delivery system with ergonomic release handle

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

    Tri-axial delivery system: the outer shaft isolates the retractable shaft from friction caused by the introducer valve to ensure accurate stent deployment.

    Clinical Highlights

    Technical Data

    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 6F, hydrophobic coating
    Usable length 90 and 135 cm

    Ordering Information

      Stent

    ø (mm)    		 Catheter length 90 cm

    (Stent length mm)
        30 40 60 80 100 120 150 170 200
    6F 5 379878 379879 379880 379881 379917 379918 379919 379920 379921
    6 379883 379884 379885 379886 379922 379923 379924 379925 379926
    7 379888 379889 379890 379891 379927 379928 379929 379930 379931
      Stent

    ø (mm)    		 Catheter length 135 cm

    (Stent length mm)
        30 40 60 80 100 120 150 170 200
    6F 5 379898 379899 379900 379901 379937 379938 379939 379940 379941
    6 379903 379904 379905 379906 379942 379943 379944 379945 379946
    7 379908 379909 379910 379911 379947 379948  379949 379950 379951

     

     

    Downloads and Related Links

    Downloads

    Download Brochure Download IFU

    Related Links

    Pulsar-18 T3 - Self-Expanding Stent System

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    References

    TLR = Target Lesion Revascularization; A.L.L = Average Lesion Length

    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. 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; 8.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; 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. 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: Millennium Research Group Inc.).

    *Indication as per IFU. Pulsar and proBIO are trademarks or registered trademarks of the BIOTRONIK Group of Companies. All other trademarks are the property of their respective owners.