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

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Covered single stent design1

deliverability icon

Exceptional deliverabilityc,1,4

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Clinically provenb,3

>1,500

Patients with PK Papyrus studied in clinical studies.5

13

Number of publications available.6

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,1,4

Consistently high stent delivery successf,4,7-10

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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SCAAR9

The only covered stent with > 90% procedural success rate

Observational srudy comparing stents with the overall stented population.

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PAST-PERF REGISTRY8

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. Overview of publications on PK Papyrus™ Covered Coronary Stent System and BeGraft™ Coronary Stent Graft System, Data on file as of 25 March 2026.
  4. 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;31:617–23.
  5. Overview of clinical trials based on an intensive literature research including sponsored and IITs for CAP patient number treated with PK Papyrus™ Covered Coronary Stent System, Data as of July 2022 - data on file.
  6. Overview of publications based on a systematic literature research including sponsored and IITs for CAP patient number treated with PK Papyrus™ Covered Coronary Stent System, Data on file as of March 2026.
  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. Birkemeyer R et al. Sealing of Coronary Perforations With a Second-Generation Covered Stent Graft - Results From the PAST-PERF Registry. Cardiovascular Revascularization Medicine 25 (2021) 20–26. doi: 10.1016/j.carrev.2020.10.012.
  9. Harnek J, James S and Lagerqvist B. Very long-term outcome of coronary covered stents: a report from the SCAAR registry. EuroIntervention 2019;14:1660-1667 published online. doi: 10.4244/EIJ-D-18-00855.
  10. 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.
  11. Data on file, IIB 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.