PK Papyrus®

    Designed to save lives when seconds count

    PK Papyrus covered coronary stent is indicated for acute coronary artery perforations.a Delivers more like a conventional stent, allowing to seal coronary artery perforations with confidence.1,

    Category

    Vascular Intervention Coronary Covered Stent System

    Product Highlights

    Covered single stent design

    With a thin and highly elastic polyurethane membrane1

    Low crossing profile¹

    5F guide catheter compatibilitya1

    Exceptional deliverabilityᵇ¹⁻²

     Delivers more like a conventional stent1

    Covered single stent design

    Enables a smaller crossing profile compared to the traditional sandwich design stent.b1

    High bending flexibility¹

    With its covered single stent design, PK Papyrus covered stent achieves greater bending flexibility and a smaller crossing profile compared to the traditional sandwich design stentb, allowing you to seal perforations with confidence.1 

    Innovative polyurethane membrane

    Unique manufacturing method allows for an ultrathin membrane capable of sealing vessel perforations. Electrostatic forces spin polyurethane fibers onto the stent surface, creating a thin and highly elastic membrane.1 

    Low crossing profile¹

    23% reduction in crossing profile compared to the traditional sandwich design stent.b1

    5F Compatibility for main sizes

    The low crossing profile also means there is no need for a guide catheter upgrade on main sizes (Ø 2.5 – 4.0 mm). 

    Exceptional deliverabilityᵇ¹⁻²

    Expect a high performing platform with an ultra thin membrane to deliver more like a conventional stent.1

    Shorter median time to deliver

    Single center, retrospective investigation of 61 patients treated with covered coronary stents, show that PK Papyrus covered stent uses up to 47% less time to deliver compared to Jostent Graftmaster coronary stent graft system (PTFE-CS).c2

    Clinical Highlights

    Product Overview

    PK Papyrus

    Technical Data

    Stent  
    Stent cover material Non-woven, electrospun polyurethane
    Stent strut thickness ø 2.5 - 3.0 mm: 60 μm (0.0024”);
    ø 3.5 - 4.0 mm: 80 μm (0.0031”);
    ø 4.5 - 5.0 mm: 120 μm (0.0047”)
    Stent material Cobalt chromium (L-605) with proBIO®
    (Amorphous Silicon Carbide) coating
    Maximum stent expansion
    diameter    		 ø 2.5 - 3.0 mm: 3.50 mm;
    ø 3.5 - 4.0 mm: 4.65 mm;
    ø 4.5 - 5.0 mm: 5.63 mm
    Delivery system  
    Guidewire diameter 0.014”
    Usable catheter length 140 cm
    Recommended guide catheter ø 2.5 - 4.0 mm: 5F (min. I.D.* 0.056”);
    ø 4.5 - 5.0 mm: 6F (min. I.D.* 0.070”)
    Nominal pressure (NP) ø 2.5 - 3.5 mm: 8 atm; ø 4.0 - 5.0 mm: 7 atm
    Rated burst pressure (RBP) ø 2.5 - 4.0 mm: 16 atm; ø 4.5 - 5.0 mm: 14 atm
    *I.D. = Inner Diameter  

     

    Ordering Information

      Stent
    ø (mm)    		 Catheter length 140 cm
    Stent length (mm)
        15 20 26
    5F 2.5 369380 369386 -
    3 369381 369387 381789
    3.5 369382 369388 381790
    4 369383 369389 381791
    6F 4.5 369384 369390 369392
    5 369385 369391 369393

    Downloads and Related Links

    Downloads

    Download Brochure Download Vascular Intervention Product Catalog BIOTRONIK

    Related Links

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    References

    Humanitarian Device. Authorized by Federal law for use in the treatment of acute perforations of native coronary arteries and coronary bypass grafts in vessels 2.5 to 5.0 mm in diameter. The effectiveness of this device for this use has not been demonstrated.

    a. Indication as per IFU; b. Compared to Jostent Graftmaster 2.8/16; c. Population is representative of real world interventional practice and was not a randomized prospective clinical trial.

    1. BIOTRONIK data on file: compared to Graftmaster 2.8 /16 and compared to Jostent Graftmaster 3.0/16; 2. Hernandez-Enriquez M, Lairez O, Campelo-Parada F, et al. Outcomes after use of covered stents to treat coronary artery perforations. Comparison of old and new-generation covered stents. J Interv Cardiol. 2018;1–7. doi: 10.1111/joic.12525; 3. Birkemeyer R , Olivecrona G.K, Hellig F et al., Sealing of coronary perforations with a second-generation covered stent graft - Results from the PAST-PERF registry. Cardiovascular Revascularization Medicine. 2020; doi:10.1016/j.carrev.2020.10.012; 4. Harnek J et al. Very long-term outcome of coronary covered stents: a report from the SCAAR registry, EuroIntervention 2019;14:1660-1667. Procedural success rates were calculated based on implanted covered stents and excluded totally unsuccessful implant attempt, which may have increased the reported success rates.; 5. Kandzari D.E. , Sarao R.C. and Waksman R. Clinical experience of the PK Papyrus covered stent in patients with coronary artery perforations: Results from a multi-center humanitarian device exemption survey, Cardiovascular Revascularization Medicine. 2022. doi: 10.1016/j.carrev.2022.04.009.

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