PK Papyrus

PK Papyrus® — покрытый коронарный стент, предназначенный для лечения острых перфораций коронарных артерий. Уникальная конструкция с одинарным стентом и ультратонкой полиуретановой мембраной обеспечивает исключительную доставляемость, сравнимую с обычными стентами. Совместим с 5F направляющими катетерами для основных размеров, что позволяет быстро и эффективно герметизировать перфорации в критических ситуациях.

Описание

PK Papyrus®

Covered single stent design

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

Covered single stent design

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

High bending flexibility

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

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 profile

Low crossing profile¹

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

5F Compatibility

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 deliverability

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

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

HDE Post-Market Surveillance Survey⁵

94.2% Successful sealing following delivery
Clinical experience of the PK Papyrus covered stent in patients with coronary artery perforations

SCAAR⁴

The only covered stent with > 90% procedural success rate
Observational study comparing covered stents with the overall stented population.

Past-Perf Registry³

Low TLR (7.7%) and low definite ST (3.3%) at 12 months
International, investigator-initiated, retrospective multicenter registry to collect data on PK Papyrus covered stent

PK Papyrus Product Overview

Product Overview

Technical Data

  • Stent cover material: Non-woven, electrospun polyurethane
  • Stent strut thickness: ø 2.5 — 3.0 mm: 60 μm; ø 3.5 — 4.0 mm: 80 μm; ø 4.5 — 5.0 mm: 120 μm
  • Stent material: Cobalt chromium (L-605) with proBIO® coating
  • Guidewire diameter: 0.014″
  • Usable catheter length: 140 cm
  • Recommended guide catheter: ø 2.5 — 4.0 mm: 5F; ø 4.5 — 5.0 mm: 6F
Дополнительные материалы

Дополнительные материалы

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
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
Stent ø (mm) 15 mm 20 mm 26 mm
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
Описание

PK Papyrus®

Covered single stent design

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

Covered single stent design

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

High bending flexibility

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

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 profile

Low crossing profile¹

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

5F Compatibility

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 deliverability

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

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

HDE Post-Market Surveillance Survey⁵

94.2% Successful sealing following delivery
Clinical experience of the PK Papyrus covered stent in patients with coronary artery perforations

SCAAR⁴

The only covered stent with > 90% procedural success rate
Observational study comparing covered stents with the overall stented population.

Past-Perf Registry³

Low TLR (7.7%) and low definite ST (3.3%) at 12 months
International, investigator-initiated, retrospective multicenter registry to collect data on PK Papyrus covered stent

PK Papyrus Product Overview

Product Overview

Technical Data

  • Stent cover material: Non-woven, electrospun polyurethane
  • Stent strut thickness: ø 2.5 — 3.0 mm: 60 μm; ø 3.5 — 4.0 mm: 80 μm; ø 4.5 — 5.0 mm: 120 μm
  • Stent material: Cobalt chromium (L-605) with proBIO® coating
  • Guidewire diameter: 0.014″
  • Usable catheter length: 140 cm
  • Recommended guide catheter: ø 2.5 — 4.0 mm: 5F; ø 4.5 — 5.0 mm: 6F
Дополнительные материалы

Дополнительные материалы

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
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
Stent ø (mm) 15 mm 20 mm 26 mm
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

ООО «Медикор» 
ИНН 7326046490
ОГРН 1147326001239

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