s.m.a.r.t. flex vascular stent system - emea. · pdf filethe data provided in this brochure...

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S.M.A.R.T.™ Flex Vascular Stent System

Feeling is believing.


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1. The data provided in this brochure are based on mechanical and in-vitro testings performed by Cordis Corporation (data on file, Cordis). Those data are intended to provide technical information based on in-vitro testings for which results cannot be transposed to clinical interpretation.

Want to feel the difference? Call your Cordis representative.

Experience the latest innovation in self-expanding stents. You’ll feel the difference.

Superior fracture resistance

High radial force

Greater longitudinal stability

Deployment confidence

Noticeably flexible

Complete portfolio of sizes

FEELING IS BELIEVING.

The S.M.A.R.T.™ Flex Vascular Stent System is more than a single product; it’s a

total portfolio commitment. In addition, it’s an example of Cordis providing leadership you can count on—through innovations that reflect outstanding engineering, performance, and an accelerated commitment to excellence.

EXPERIENCE THE LATEST INNOVATION IN SELF-EXPANDING STENTS.

The S.M.A.R.T.™ Flex Vascular Stent System

was inspired by the native vessel—and designed to overcome the

constant biomechanical challenges that stents face. It builds on the

strength of our proven S.M.A.R.T.™ Stent and is engineered with

outstanding flexibility, making it the only fully connected yet highly

flexible self-expanding stent. It’s a difference you can feel in the stent

and in your procedures.


Helical strut bandsprovide radial force

Greater longitudinal stability and fracture resistance

Exceptional stability can help to reduce stent stretching during deployment, thereby increasing placement accuracy and achieving the intended radial force and scaffolding

Small cell size and uniform coverage ensure optimal scaffolding to minimize lesion prolapse1

Complete portfolio of sizes Gives you the flexibility to treat both longer and small-diameter lesions in superficial femoral artery and proximal popliteal artery

Cordis S.M.A.R.T.™ Flex Stent

Cook Zilver® StentP<.0001

Covidien EverFlex+™ Stent

P<.0001

Bard LifeStent® Stent

P<.0001

AbbottAbsolute® Stent

P<.0001

LONGITUDINAL STABILITY Force Needed to Stretch 50% Lengthwise (N)1

116.40

1.34 1.19 .80 .68

S.M.A.R.T.™ FLEX STENT SIZES

5–8 mmdiameters

30–200 mm lengths

Higher value for higher longitudinal stability.

Flex bridgesprovide complete scaffolding

with flexibility

Built upon the PALMAZ™ heritage with a tissue-to-metal ratio of 80% to 90% and high radial strength

Excellent fracture resistance due to helical strut bands and diameter-specific design

Complete portfolio of sizes for treating both longer and small-diameter lesions

Placement accuracy is supported by low deployment forces and fully connected architecture

Outstanding flexibility as a result of multiple flex bridges

Superior longitudinal stability from fully connected design and scaffolding1


DELIVERS OUTSTANDING DURABILITY AND RADIAL FORCE.

Superior fracture resistance1

No fractures observed in 10-million-cycle in-vitro testing protocol (axial compression cycle 0 –14%)



Cook Zilver™ Stent*

Bard LifeStent™ Stent


Abbott Absolute™ Stent

FRACTURE RESISTANCE Mean Cycle Count (K) to First Fracture1

10,000

1,000 500 50 10

Higher cycle counts for higher fracture resistance.* Two of the first four stents fractured.

High radial force

Ability to resist compression and maximize luminal diameter, enabling increased blood flow1

Cordis S.M.A.R.T.™ Stent



P<.0001


P<.0001

AbbottAbsolute™ Stent

P<.0001

CookZilver™ Stent

P<.0001

RADIAL FORCE (N/cm)1

1.43 1.411.21

1.07.97

.65

INCREASED RADIAL FORCE MAXIMIZES LUMINAL GAIN

S.M.A.R.T.™ Flex Vascular Stent System is designed to

maintain luminal gain

r = 6 mm

1 mm gain in radius = 56% greater flow

2 mm gain in radius

= 125% greater flow

r = 5 mmr = 4 mm

Stent

Vessel

Greater radial force = Larger lumen = More flow

Flow = 36πVFlow = 25πVFlow = 16πV

Higher value for better radial force.

EASY TO PLACE. STRONG ON STABILITY.


Fully connected design is intended to minimize stretching at deployment, facilitating accurate placement

Lower chronic force at deployment contributes to easy, accurate stent placement1

Distal and proximal radiopaque markers help facilitate accurate placement

Simple delivery system for easy deployment Radiopaque markers



Cook Zilver® Stent

P<.0001


P<.0001


P<.0001


P<.0001

CHRONIC OUTWARD FORCE (N)1

.13

.24 .25

.33.40

UNIQUE DESIGN PROVIDES UNIFORM SCAFFOLDING AND SMALL CELL SIZE


36 Struts/4 Bridges

Cook Zilver™ Stent

24 Struts/4 Bridges

ev3 Protégé™ EverFlex™ Stent

32 Struts/4 Bridges


12 Struts/3 Bridges


32 Struts/16 Bridges*

* 32 struts/16 bridges for 7 mm and 8 mm diameter stents. 26 struts/13 bridges for 5 mm and 6 mm diameter stents.

Lower value for lower COF.





High radial force



Noticeably flexible



The S.M.A.R.T.™ Flex Vascular Stent System is more than a single product; it’s a

total portfolio commitment. In addition, it’s an example of Cordis providing leadership you can count on—through innovations that reflect outstanding engineering, performance, and an accelerated commitment to excellence.
















Cook Zilver® StentP<.0001


P<.0001

Bard LifeStent® Stent

P<.0001

AbbottAbsolute® Stent

P<.0001


116.40

1.34 1.19 .80 .68


5–8 mmdiameters

30–200 mm lengths






High radial force



Noticeably flexible



The S.M.A.R.T.™ Flex Vascular Stent System is more than a single product; it’s a total portfolio commitment. In addition, it’s an example of Cordis providing leadership you can count on—through innovations that reflect outstanding engineering, performance, and an accelerated commitment to excellence.















Cordis S.M.A.R.T.

™

Flex Stent

Cook Zilver

® Stent

P<.0001

Covidien EverFlex+

™ Stent

P<.0001

Bard LifeStent

® Stent

P<.0001

AbbottAbsolute

® Stent

P<.0001


116.40

1.341.19.80.68


5–8 mmdiameters

30–200 mm lengths



Our inspiration cameright from the source.

Experience the latest innovation in self-expanding stents.


Feeling is believing.

Ordering Information

SF05030SV SF05030MV 5 30 3.5-4.5 6 .035"

SF05040SV SF05040MV 5 40 3.5-4.5 6 .035"

SF05060SV SF05060MV 5 60 3.5-4.5 6 .035"

SF05080SV SF05080MV 5 80 3.5-4.5 6 .035"

SF05100SV SF05100MV 5 100 3.5-4.5 6 .035"

SF05120SV SF05120MV 5 120 3.5-4.5 6 .035"

SF05150SV SF05150MV 5 150 3.5-4.5 6 .035"

SF05200SV SF05200MV 5 200 3.5-4.5 6 .035"

SF06030SV SF06030MV 6 30 4.5-5.5 6 .035"

SF06040SV SF06040MV 6 40 4.5-5.5 6 .035"

SF06060SV SF06060MV 6 60 4.5-5.5 6 .035"

SF06080SV SF06080MV 6 80 4.5-5.5 6 .035"

SF06100SV SF06100MV 6 100 4.5-5.5 6 .035"

SF06120SV SF06120MV 6 120 4.5-5.5 6 .035"

SF06150SV SF06150MV 6 150 4.5-5.5 6 .035"

SF06200SV SF06200MV 6 200 4.5-5.5 6 .035"

SF07030SV SF07030MV 7 30 5.5-6.5 6 .035"

SF07040SV SF07040MV 7 40 5.5-6.5 6 .035"

SF07060SV SF07060MV 7 60 5.5-6.5 6 .035"

SF07080SV SF07080MV 7 80 5.5-6.5 6 .035"

SF07100SV SF07100MV 7 100 5.5-6.5 6 .035"

SF07120SV SF07120MV 7 120 5.5-6.5 6 .035"

SF07150SV SF07150MV 7 150 5.5-6.5 6 .035"

SF07200SV SF07200MV 7 200 5.5-6.5 6 .035"

SF08030SV SF08030MV 8 30 6.5-7.5 6 .035"

SF08040SV SF08040MV 8 40 6.5-7.5 6 .035"

SF08060SV SF08060MV 8 60 6.5-7.5 6 .035"

SF08080SV SF08080MV 8 80 6.5-7.5 6 .035"

SF08100SV SF08100MV 8 100 6.5-7.5 6 .035"

SF08120SV SF08120MV 8 120 6.5-7.5 6 .035"

SF08150SV SF08150MV 8 150 6.5-7.5 6 .035"

Product Code Stent Delivery System

80 cm Usable 120 cm Usable Stent Stent Recommended Recommended Sheath Guidewire Length Length Diameter (mm) Length (mm) Lumen Size (mm) Introducer Size Acceptance

Important Information: Prior to use, refer to the “Instructions for Use” supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings, and precautions. As part of the Cordis policy of continuous product development, we reserve the right to change product specifications without prior notification. For healthcare professionals only.© 2017 Cardinal Health. All Rights Reserved. CORDIS, the Cordis LOGO, PALMAZ and S.M.A.R.T. FLEX are trademarks of Cardinal Health and may be registered in the US and/or in other countries. All other marks are the property of their respective owners. EU244-1 06/17

S.M.A.R.T.™ Flex Vascular Stent System Product Description

Stent Diameters: 5-8 mm (Stent diameter should be 0.5-1.5 mm greater than vessel diameter)Stent Delivery System Working Lengths: 80 cm (S suffix) and 120 cm (M suffix)

Type: Fully connected yet flexible stent designMaterial: Nitinol, with tantalum markers on stent endsMaximum Guidewire: 0.035"Stent Lengths: 30-200 mmSheath Compatibility: 6F

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