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PK Papyrus®

Designed to save lives when seconds count

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

Category

Vascular Intervention Coronary Covered Stent System

Product Highlights

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Covered single stent design

With a thin and highly elastic polyurethane membrane1

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Low crossing profile¹

5F guide catheter compatibilitya1

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Exceptional deliverabilityᵇ¹⁻²

 Delivers 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.

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 like a conventional stent.1

81% greater flexibility

PK Papyrus covered stent achieves 81% greater flexibility compared to the traditional sandwich design stent.b1

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

Product Overview

PK Papyrus

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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  
Guide wire 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

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References

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; 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. Kandzari D, Birkemeyer R. PK Papyrus covered stent: Device description and early experience for the treatment of coronary artery perforations Catheter Cardiovasc Interv. 2019;1–5. doi: 10.1002/ccd.28306; 5. Harnek J et al. Very long-term outcome of coronary covered stents: a report from the SCAAR registry, EuroIntervention 2019;14:1660-1667; 6. 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; 7. Harnek J et al. Very long-term outcome of coronary covered stents: a report from the SCAAR registry, EuroIntervention 2019;14:1660-1667. 

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.