eucaLimus - EUCATECH · eucaLimus. Sirolimus Eluting Coronary Stent System. Ultrathin 65 µm...

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Quality. Made in Germany eucaLimus Sirolimus Eluting Coronary Stent System Ultrathin 65 µm Design Excellent Deliverability Degradable Polymermatrix Synchronized Polymerdegradation and Drug Release Wide Range of Diameters up to 5.0 mm Stent Lengths up to 48 mm 36 Months Shelf Life CORONARY INTERVENTION www.eucatech.de

Transcript of eucaLimus - EUCATECH · eucaLimus. Sirolimus Eluting Coronary Stent System. Ultrathin 65 µm...

Page 1: eucaLimus - EUCATECH · eucaLimus. Sirolimus Eluting Coronary Stent System. Ultrathin 65 µm Design. Excellent Deliverability. Degradable Polymermatrix. Synchronized Polymerdegradation

Quality. Made in Germany

eucaLimusSirolimus Eluting Coronary Stent System

■ Ultrathin 65 µm Design ■ Excellent Deliverability ■ Degradable Polymermatrix ■ Synchronized Polymerdegradation and Drug Release ■ Wide Range of Diameters up to 5.0 mm ■ Stent Lengths up to 48 mm ■ 36 Months Shelf Life

CORONARY INTERVENTION

www.eucatech.de

Page 2: eucaLimus - EUCATECH · eucaLimus. Sirolimus Eluting Coronary Stent System. Ultrathin 65 µm Design. Excellent Deliverability. Degradable Polymermatrix. Synchronized Polymerdegradation

eucaLimusSirolimus Eluting Coronary Stent System

Ultra Thin 65 µm Strutdesign

Stent Delivery System ■ Enhanced Balloon Material Improves Flexibility and Trackability ■ High Performance Hydrophilic Coating for minimal Friction ■ Laser Cutted 1:1 Transmission Zone from Hypotube to Distal Part ■ Dual Tapered Atraumatic Tip

Crossing Profile ■ Low profile (0.97 mm for expansion-Ø 3.0 mm) ■ Capability to pass even long and tortous lesions

65 µm Struts ■ Lower Crossing Profile ■ Easier Crossability ■ Less Vessel Injury

9 Crown Structure ■ Excellent Vessel Coverage ■ Reduced Local Force ■ Homogeneous Drug Distribution

Interlinks ■ Middle to Middle Design ■ Slimmer, More Flexible Links ■ Increased Deliverability ■ Increased Vessel Adaption

0.017" (0.43 mm) Tip Profile

Platinum Iridium Marker BandHydrophilic Coating

Laser Cut Hypotube

PTFE Coated Hypotube

Side Branch AccessLarge cell opening gives comfort to access side branches and cross with multiple devices

Page 3: eucaLimus - EUCATECH · eucaLimus. Sirolimus Eluting Coronary Stent System. Ultrathin 65 µm Design. Excellent Deliverability. Degradable Polymermatrix. Synchronized Polymerdegradation

Coating (Drug Polymer) Coating Technology

e-beam Sterilization ■ Dry sterilization ■ No start of polymer degradation ■ 100 % repeatability of drug release ■ Shelf Life of 3 years

Sirolimus (Rapamycin)Target the cell cycle, inhibiting the effects of injury mediated growth factors and cytokines that produce vascular smooth muscle proliferation and intimal hyperplasia.

Asymmetrical CoatingIncrease of drug delivery efficiency due to the asymmetrical coating

PLGA 85/15 polylactide-co-glycolideLactic Acid and Glycolic Acid are metabolits of the natural cellular metabolism. Both substances are decomposed to CO2 and H2O during a 10 – 13 weeks period.

Coating IntegrityCoating remains intact at maximum post dilatation expansion of 4.5 mm

Adjusted Polymer Resorption / Drug Release

Page 4: eucaLimus - EUCATECH · eucaLimus. Sirolimus Eluting Coronary Stent System. Ultrathin 65 µm Design. Excellent Deliverability. Degradable Polymermatrix. Synchronized Polymerdegradation

Quality. Made in Germany

eucaLimusSirolimus Eluting Coronary Stent System

eucatech AGRebgartenweg 27D-79576 Weil am RheinPhone: + 49 7621 4220 - 0Fax: + 49 7621 4220 - 100E-Mail: [email protected]: www.eucatech.com

© eucatech AG - All rights reserved.Specifications are subject to modification, revision and improvement.

36 MONTHS SHELF LIFE

14341

ELM

_EN

_1_0

4-20

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STENT SPECIFICATIONSType of design Open-cell, 3 interlinksDesign details 9 crownsMaterial Cobalt Chromium L605Expansion range 2.25 mm – 5.00 mmStrut thickness Ø 2.25 – 4.0 0.0026" (65 μm)

Ø 4.50 – 5.0 0.0042" (107 μm)Strut width (main segment)

Ø 2.25 – 4.0 0.0028" (72 μm)Ø 4.50 – 5.0 0.0043" (110 μm)

Strut width (interlink)

Ø 2.25 – 4.0 0.0023" (58 μm)Ø 4.50 – 5.0 0.0029" (73 μm)

Foreshortening < 2.5%Mechanical recoil < 6%Metal coverage < 13.6%Matrix thickness 3 – 5 µmDrug / Polymer Sirolimus / PLGADrug load 1.4 µg / mm2

DELIVERY SYSTEM SPECIFICATIONSUsable length 138 cmLength guidewire lumen 27 cmRecommended guide catheter 5F (min. I.D. 0.056")Material Balloon Proprietary polyamide

compoundDistal shaft Polyamide, multilayer tube

Hydrophilic coatingProximal shaft Stainless steel, PTFE coated

Shaft size Proximal 1.9 FDistal 2.8 – 3.0 F, depending on

balloon-ØFolding 2.25 – 4.00 mm 3-fold balloon

4.50 – 5.00 mm 5-fold balloonMarker bands Embedded Platinum / IridiumTip entry profile 0.017" (0.43 mm)Max. guidewire 0.017" (0.43 mm)Sterilization method e-beam

COMPLIANCE CHART

Pressure [MPa / bar]Stent I.D. [mm]

2.25 2.50 2.75 3.00 3.25 3.50 4.00 4.50 5.000.8 / 8 2.25 2.50 2.75 3.00 3.25 3.50 4.00 4.50 5.000.9 / 9 2.27 2.53 2.78 3.03 3.28 3.54 4.04 4.54 5.041.0 / 10 2.29 2.56 2.81 3.06 3.31 3.58 4.08 4.59 5.081.1 / 11 2.32 2.60 2.83 3.08 3.34 3.61 4.12 4.63 5.121.2 / 12 2.34 2.63 2.86 3.11 3.37 3.65 4.16 4.68 5.151.3 / 13 2.36 2.66 2.89 3.14 3.41 3.69 4.19 4.72 5.191.4 / 14 2.38 2.69 2.92 3.17 3.44 3.73 4.23 4.77 5.231.5 / 15 2.40 2.72 2.95 3.19 3.47 3.76 4.27 4.81 5.271.6 / 16 2.42 2.76 2.97 3.22 3.50 3.80 4.31 – –1.7 / 17 2.45 2.79 3.00 3.25 3.53 – – – –1.8 / 18 2.47 2.82 3.03 – – – – – –1.9 / 19 2.49 – – – – – – – –Nominal pressure 0.8 MPa / 8 bar Rated burst pressure Do not exceed

ORDER INFORMATION

Stent I.D.Stent length

8 mm 10 mm 13 mm 16 mm 18 mm 23 mm 28 mm 33 mm 38 mm 43 mm 48 mm2.25 mm ELM22508 ELM22510 ELM22513 ELM22516 ELM22518 ELM22523 ELM22528 ELM22533 ELM22538 – –

2.50 mm ELM25008 ELM25010 ELM25013 ELM25016 ELM25018 ELM25023 ELM25028 ELM25033 ELM25038 ELM25043 –

2.75 mm ELM27508 ELM27510 ELM27513 ELM27516 ELM27518 ELM27523 ELM27528 ELM27533 ELM27538 ELM27543 ELM27548

3.00 mm ELM30008 ELM30010 ELM30013 ELM30016 ELM30018 ELM30023 ELM30028 ELM30033 ELM30038 ELM30043 ELM30048

3.25 mm ELM32508 ELM32510 ELM32513 ELM32516 ELM32518 ELM32523 ELM32528 ELM32533 ELM32538 ELM32543 ELM32548

3.50 mm ELM35008 ELM35010 ELM35013 ELM35016 ELM35018 ELM35023 ELM35028 ELM35033 ELM35038 ELM35043 ELM35048

4.00 mm ELM40008 ELM40010 ELM40013 ELM40016 ELM40018 ELM40023 ELM40028 ELM40033 ELM40038 ELM40043 ELM40048

4.50 mm – – ELM45013 ELM45016 ELM45018 ELM45023 ELM45028 ELM45033 ELM45038 – –

5.00 mm – – ELM50013 ELM50016 ELM50018 ELM50023 ELM50028 ELM50033 ELM50038 – –