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Europe, Middle East, Africa / Product Areas / Interventional Cardiology/Radiology / Coronary Interventions / PK Papyrus

PK Papyrus™ Covered Coronary Stent System

Designed to save lives when seconds count1,2

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

Pantera Lux product image

Product Highlights

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Clinically provenb,3-15

Covered icon

Covered single stent design1

deliverability icon

Exceptional deliverabilityc,1,3

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Clinically provenb,3-15

>1,500

Patients with PK Papyrus™ studied in clinical studies.16

10

Number of publications available.3-12

93.7%

Patients were not referred to emergency cardiac surgery.d,7

PK Papyrus™ is safe and effective as confirmed by one of the largest patient datasets for covered stents.e,7

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Covered single stent design

Innovative polyurethane membrane1

Unique manufacturing method allows for an ultra thin membrane capable of sealing vessel perforations1 and achieve a true covered single stent design1. Expect a high performing platform with an ultra thin membrane to deliver like a conventional stent.1

PK Papyrus Illustration
deliverability icon

Exceptional deliverabilityc,1,3

Consistently high stent delivery successf,3-7

PK Papyrus™ is associated with reliable delivery (97.7% stent delivery success) and successful sealing (92.1%), favored by its unique design.7

PK Papyrus Delivery system charts

Clinical Highlights

HDE POST-MARKET SURVEILLANCE SURVEY7

94.2% Successful following delivery

Clinical experience of the PK Papyrus covered stent in patients with coronary artery perfortations: Results from a multi-center Humanitarian Device Exemption (HDE) survey

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SCAAR4

The only covered stent with > 90% procedural success rate

Observational srudy comparing stents with the overall stented population.

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PAST-PERF REGISTRY5

Low TLR (7.7%) and low define ST (3.3%) at 12 months

International, investigator-initiated, retrospective multicenter registry to collect data on PK Papyrus covered stent

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Product Overview


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

Stent Catheter length 140 cm
ø (mm) (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

IFU Link

Refer to this IFU link for a copy of the Instructions for Use and for a complete listing of the indications, contraindications, warnings and precautions.

References:

  1. Indication as per IFU
  2. More clinical studies including larger number of patients reporting clinical outcomes with longer follow-up time than BeGraft Coronary Stent Graft System
  3. Compared to Jostent Graftmaster
  4. In 93.7% of coronary artery perforation cases
  5. Based on the clinical experience of the PK Papyrus covered stent in patients with coronary artery perforations: results from the multi-center humanitarian device exemption survey. Cardiovascular Revascularization Medicine. 2021
  6. Based on over a 1,000 patients treated with PK Papyrus covered coronary stent system, Clinical program as of July 2022 - data on file
  7. In crimped state

  1. Data on file
  2. Al-Lamee R, et al. Incidence, Predictors, Management, Immediate and Long-Term Outcomes Following Grade III Coronary Perforation. JACC: Cardiovasc Interv. 2011 Jan; 4(1):87-95
  3. Hernandez-Enriquez M, 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
  4. Harnek J, James SK, Lagerqvist BO. et al. Very long-term outcome of coronary covered stents: a report from the SCAAR registry. EuroIntervention. 2019; 14: 1660-1667. doi: 10.4244/ EIJ-D-18-00855
  5. 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
  6. Kandzari DE, 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.org/10.1002/ccd.28306
  7. 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
  8. Nagaraja V , Schwarz K et al. Outcomes of patients who undergo percutaneous coronary intervention with covered stents for coronary perforation: A systematic review and pooled analysis of data. Catheter Cardiovasc Interv. 2019; 1-7. DOI: 10.1002/ccd.28646
  9. Hernandez-Enriquez et al. Use and outcomes of the PK Papyrus covered stent in France: SOS PK Papyrus registry. Catheter Cardiovasc Interv. 2020; doi: 10.1002/ccd.29328
  10. Wańha W, Januszek R, Kołodziejczak M, Kuźma Ł, Tajstra M, Figatowski T et al. Procedural and 1-year outcomes following large vessel coronary artery perforation treated by covered stents implantation: Multicentre CRACK registry. PLoS ONE. 2021; 16(5): e0249698. doi: 10.1371/journal.pone.0249698
  11. Bossard, M., Maria Cioffi G., et al. “Burying” covered coronary stents under drug-eluting stents: A novel approach to ensure long-term stent patency. Cardiology Journal, 2023, 30(2), 196-198. https://doi.org/10.5603/CJ.a2022.0116
  12. Jurado-Roman A et al. Clinical outcomes after implantation of polyurethane-covered cobalt-chromium stents. Insights from the Pa-pyrus-Spain registry. Cardiovascular Revascularization Medicine 2020 Aug; S1553-8389(20)30486-3. doi: 10.1016/j.carrev.2020.08.017. Online ahead of print
  13. Kufner S et al. Outcome after new generation single-layer polytetrafluoroethylenecovered stent implantation for the treatment of coronary artery perforation. Catheter Cardiovasc Interv. 2018; 1-9. DOI: 10.1002/ccd.27979
  14. Voll F, Koch T, Tölg R, Lenz T, Schroeter M, Lenders G, Hokken R, Cassese S, Xhepa E, Schunkert H, Kastrati A, Kufner S. Clinical safety and efficacy of new generation single-layer polytetrafluorethylene covered coronary stents. Cardiovasc Revasc Med.2023:1-7
  15. Azzalini, L., Poletti, E., Ayoub, M., Ojeda, S., Zivelonghi, C., La Manna, A., Bellini, B., Lostalo, A., Luque, A., Venuti, G., Montorfano, M., Agostoni, P., Pan, M., Carlino, M., & Mashayekhi, K. Coronary artery perforation during chronic total occlusion percutaneous coronary intervention: Epidemiology, mechanisms, management, and outcomes. EuroIntervention. 2019. https:// doi.org/10.4244/ EIJ-D-19-00282
  16. Overview of clinical trials based on an intensive literature research for CAP patient number treated with PK Papyrus covered coronary stent system, Data as of July 2022 - data on file
  17. Data on file, data 2020, PK Papyrus Ø 3.0, 15 mm vs. BeGraft Coronary Stent Graft System Ø 3.0, 16 mm

Teleflex, the Teleflex logo, PK Papyrus and proBIO are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. Information in this material is not a substitute for the product Instructions for Use. Not all products may be available in all countries. Please contact your local representative. All other names are the trademarks or registered trademarks of their respective owners. Refer to this IFU link for a copy of the Instructions for Use and for a complete listing of the indications, contraindications, warnings and precautions. Information in this material is not a substitute for the product Instructions for Use.

© 2025 Teleflex Incorporated. All rights reserved. Revised 09/2025.