when outcomes matter, design matters - cordis · design matters for superficial femoral artery...

Cordis S.M.A.R.T.™ Self-Expanding Nitinol StentLower Extremity Solutions

When Outcomes Matter, Design Matters

For superficial femoral artery (SFA) and iliac lesions.Achieve optimal patient outcomes through design.

1-year STROLL study results inside

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Effective SFA revascularization through 1 year with the S.M.A.R.T.™ Self-Expanding Nitinol Stent1

OUTCOMES MATTER

Clinical outcomes at 1 year Patient outcomes at 1 year

81.7% primary patency‡

87.6% freedom from TLR

2.0% stent fracture rate (all Type I)

76.6% of patients had minimal

or no PAD symptoms§

81.0% of patients had

normal ABI (>0.8)

*The S.M.A.R.T.™ Self-Expanding Nitinol Stent in the Treatment of Obstructive Superficial Femoral Artery Disease (STROLL) study. Cordis data on file, 2012. †A principal investigator of the STROLL study. ‡Defined per Kaplan-Meier estimate, according to secondary analysis as no significant reduction in flow detectable by duplex ultrasound and no further clinically driven target lesion revascularization. §Defined as Rutherford-Becker classification 0 or 1.

Compelling outcomes in the STROLL* study

Reference: 1. Data on file 2012, Cordis Corporation.

Patients in this nonrandomized, single-arm

study to be

followedfor up to

3 years

STROLL study design1

250 patients enrolled at

39 sites in the United States

“ The STROLL outcomes both meet and exceed our expectations for patients with symptomatic disease of the superficial femoral artery.”

— Dr William A. Gray,† Director of Endovascular Services Cardiovascular Research Foundation, New York

Scaffolding

Smaller cell size and uniform coverage can help prevent vessel prolapse.

Longitudinal stability

Greater stability minimizes stretching at deployment, thereby increasing placement accuracy.

Radial force

The stent’s ability to resist compression maintains luminal gain.

S.M.A.R.T.™ Self-Expanding Nitinol Stent—design is key

Designed for optimal performance

Unique 36 strut /6 bridge construction

6 Alternating BridgesEach ring is connected by 6 bridges for greater longitudinal stability.36 Struts

Each circumferential ring contains 36 struts, providing radial force and scaffolding.

Segmented Micromesh Geometry The unique micromesh design allows for consistent radial force, uniform scaffolding, and small cell size.

Offset Peak-to-Valley Design The offset design provides smooth lumen and stent contourability without strut overlapping or fish-scaling.

DESIGN MATTERS

Overview

1

Pate

ncy

(%)

Time after initial procedure (months)

00 1 2 3 4 5 6 7 8 9 10 11 12

20

40

60

80

100

81.7%*primary patency

at 1 year

Free

do

m F

rom

Clin

ical

ly D

rive

n T

LR (%

)

Time after initial procedure (months)

00 1 2 3 4 5 6 7 8 9 10 11 12

20

40

60

80

100

87.6%freedom from TLR

at 1 year

Reference: 1.The S.M.A.R.T.™ Self-Expanding Nitinol Stent in the Treatment of Obstructive Superficial Femoral Artery Disease (STROLL) study. Cordis data on file, 2012.

* Defined per Kaplan-Meier estimate, according to secondary analysis as no significant reduction in flow detectable by duplex ultrasound and no further clinically driven target lesion revascularization

High primary patency rate maintained at 1 year in the STROLL study with the S.M.A.R.T.™ Self-Expanding Nitinol Stent1

Strong rate of freedom from clinically driven TLR maintained at 1 year in the STROLL study1

Achieve desired clinical outcomes

OUTCOMES MATTER

Primary patency

Freedom from TLR

2

58.4

76.6%

18.215.0 7.5

1.0Dis

trib

uti

on

of

Pati

ents

(%) a

t 1

Year

Classification

00

(no symptoms)1

(mild claudication)2

(moderate claudication)3

(severe claudication)4-6

(ischemic rest pain or tissue loss)

20

40

60

80

100

Reference: 1. The S.M.A.R.T.™ Self-Expanding Nitinol Stent in the Treatment of Obstructive Superficial Femoral Artery Disease (STROLL) Study. Cordis Data on file, 2012, Cordis Corporation

Provide critical patient outcomes

*Defined as Rutherford-Becker classification 0 or 1.

Minimal or no signs of PAD* in 3 of 4 patients at 1 year in the STROLL study as measured using Rutherford-Becker classification1

Normal ABI in 4 of 5 patients at 1 year in the STROLL study1

• 81% of patients had ABI >0.8 one year after deployment of S.M.A.R.T.™ Self-Expanding Nitinol Stent

Outcom

es

Rutherford-Becker classification

3

2.0

none

Frac

ture

Rat

e (%

) at

1 Ye

ar

0AnyType I Type II-V

1

2

3

4

5

=

2.0Only Type Ifractures

were observed in the STROLL study

References: 1. The S.M.A.R.T.™ Self-Expanding Nitinol Stent in the Treatment of Obstructive Superficial Femoral Artery Disease (STROLL) Study. Cordis data on file, 2012, cordis corporation 2.Rocha-Singh KJ et al; on behalf of VIVA Physicians, Inc. Catheter Cardiovasc Interv. 2007;69:910-919.

Adapted from Rocha-Singh et al.2

Low fracture rate through 1 year in the STROLL study with the S.M.A.R.T.™ Self-Expanding Nitinol Stent1

Assessing stent fractures, which may lead to adverse outcomes2

Experience sustained stent integrity

DURABILITY MATTERS

Stent fracture rate

Stent fracture grading scale

Type I One strut fracture

Type II Multiple strut

fractures

Type III Complete

transverse linear fracture

Type IV Complete transverse linear fracture with

displacement

Type V Complete

transaxial fracture

4

8.1

=1.6

2.4

4.1

Frac

ture

Rat

e (%

) at

1 Ye

ar

0AnyMild SevereModerate

2

4

6

8

10

90% of all stent fractures

occurred in stents that were elongated at deployment1

100% of Type IV fractures

occurred in stents that were elongated at deployment2

1.41.7

Frac

ture

Rat

e (%

) at

1 Ye

ar

0AnyType I Type IV

1

2

3

4

5

3.1

=

References: 1. Bosiers M et al. J Endovasc Ther. 2009;16:261-269. 2. Laird JR et al; for the RESILIENT Investigators. Circ Cardiovasc Interv. 2010;3:267-276.

3. Bard® LifeStent® Stent and Delivery System Vascular Application. Instructions for Use. Version 6. C.R. Bard Inc. December 2010.

Severe fractures observed at 1 year with EV3 Protégé EverFlex® Stent and Bard LifeStent® Stent

Fracture rates with other stents

EverFlex® (DURABILITY I trial)1

LifeStent® (RESILIENT trial—all phases and arms)2,3

Fracture resistance

5

Lower value =more stretchable

Statistically signi�cant difference if P<0.05

1.761.85

0.32

1.461.34 1.25 1.19

0.800.68

CordisS.M.A.R.T.™ CONTROL™

Stent

BardLifeStent®

StentP<0001

BiotronikAstron®

Stent (6F)P<0001

Boston Scienti�cInnova™

P<0001

Covidien EverFlex™ Plus StentP<0001

Covidien Protégé

EverFlex® StentP<0001

CookZilver Flex™

StentP<0001

Cook Zilver® StentP<0001

Abbott Absolute™

Stent

P<0001

TerumoMisago®

StentP<0001

2.99

Up to 834% greater stability for accurate placement with the S.M.A.R.T.™ Self-Expanding Nitinol Stent1

Unique design provides uniform scaffolding and small cell size

Statistically superior stability

DESIGN MATTERS

Reference: 1. Cordis data on file. Bench top tests performed in 2006; 2010, 2011 and 2012. 8 mm x 60 mm stents tested.

Bard LifeStent® Stent

36 Struts/4 Bridges

Cook Zilver® Stent

24 Struts/4 Bridges

ev3 Protégé® EverFlex® Stent

32 Struts/4 Bridges

Abbott Absolute® Stent

12 Struts/3 Bridges

Cordis S.M.A.R.T.™

Self-Expanding Nitinol Stent

The 6-bridge design of the S.M.A.R.T.™ Self-Expanding Nitinol Stent provides superior longitudinal stability for predictable deployment.

6

Longitudinal stability1

36 Struts/6 Bridges

S.M.A.R.T.™ Self-Expanding Nitinol Stent are designed to

maintain luminal gain

1.201.21

0.65

1.09 1.07 1.04 1.00 0.97 0.97

CordisS.M.A.R.T.™ CONTROL™

IStent

BardLifeStent®

StentP<0001

BiotronikAstron®

Stent (6F)P<0001

Boston Scienti�cInnova™

P<0001

Covidien EverFlex™

StentP<0001

Covidien Protégé

EverFlex® StentP<0001

CookZilver Flex™

StentP<0001

Cook Zilver® StentP<0001

Abbott Absolute™

Stent

P<0001

TerumoMisago®

StentP<0001

Higher value = greater radial strength

Statistically signi�cant difference if P<0.05

1.42

Reference: 1. Cordis data on file. Bench top tests performed in 2006; 2010, 2011 and 2012. 8 mm x 60 mm stents tested.

2. Volumetric flow rate = velocity x Pi x radius2

Unmatched radial force

Design

Up to 118% greater radial force than other nitinol stents with the S.M.A.R.T.™ Self-Expanding Nitinol Stent1

Increased radial force maximizes luminal gain2

r = 6mm

1mm gain in radius = 56% greater flow

2mm gain in radius

= 125% greater flow

r = 5mm

Flow = 25πV Flow = 36πV

r = 4mm

StentFlow = 16πV

Vessel

Greater radial force = Larger lumen = More flow

7

Radial force1

Cordis S.M.A.R.T.™ CONTROL™ Self-Expanding Nitinol StentOrdering Information

S.M.A.R.T.™ CONTROL™ Self-Expanding Nitinol StentProduct Description

Type MicroMesh Geometry, Segmented Design, with Delivery Handle

Material Nitinol, with MicroMarker™ Technology

Stent Diameters 6-10 mm, 12 mm, 14 mm

Stent Lenght 20 - 100 mm, 120 & 150 mm

Stent Delivery System Working Lengths 80 cm (S suffix) & 120 cm (M suffix)

Maximum Guidewire .035"

Sheath Compatibility 6F (6-10 mm), 7F (12-14 mm)

Guide Catheter Compatibility 8F (6-10 mm), 9F (12-14 mm)

Cordis S.M.A.R.T.™ Stents: Long 120 mm and 150 mm Stents

80 cm Delivery Expanded Stent Expanded Stent Profile: Sheath/ System Diameter (mm) Length Guide Fit (F)

C06120SV 6 120 6/8

C06150SV 6 150 6/8

C07120SV 7 120 6/8

C07150SV 7 150 6/8

C08120SV 8 120 6/8

C08150SV 8 150 6/8

Cordis S.M.A.R.T.™ Stents: Long 120 mm and 150 mm Stents


C06120MV 6 120 6/8

C06150MV 6 150 6/8

C07120MV 7 120 6/8

C07150MV 7 150 6/8

C08120MV 8 120 6/8

C08150MV 8 150 6/8

Cordis S.M.A.R.T.™ CONTROL™ Stents: Large, 12 X 14 mm diameter


C12030SV 12 30 7/9

C12040SV 12 40 7/9

C12060SV 12 60 7/9

C12080SV 12 80 7/9

C14030SV 14 30 7/9

C14040SV 14 40 7/9

C14060SV 14 60 7/9

C14080SV 14 80 7/9

Cordis S.M.A.R.T.®™ CONTROL™ Stents: Large, 12 X 14 mm diameter


C12040MV 12 40 7/9

C12060MV 12 60 7/9

C12080MV 12 80 7/9

C14040MV 14 40 7/9

C14060MV 14 60 7/9

C14080MV 14 80 7/9

Cordis S.M.A.R.T.™ CONTROL™ Stents


C06020SV 6 20 6/8

C06030SV 6 30 6/8

C06040SV 6 40 6/8

C06060SV 6 60 6/8

C06080SV 6 80 6/8

C06100SV 6 100 6/8

C07020SV 7 20 6/8

C07030SV 7 30 6/8

C07040SV 7 40 6/8

C07060SV 7 60 6/8

C07080SV 7 80 6/8

C07100SV 7 100 6/8

C08020SV 8 20 6/8

C08030SV 8 30 6/8

C08040SV 8 40 6/8

C08060SV 8 60 6/8

C08080SV 8 80 6/8

C08100SV 8 100 6/8

C09020SV 9 20 6/8

C09030SV 9 30 6/8

C09040SV 9 40 6/8

C09060SV 9 60 6/8

C09080SV 9 80 6/8

C10020SV 10 20 6/8

C10030SV 10 30 6/8

C10040SV 10 40 6/8

C10060SV 10 60 6/8

C10080SV 10 80 6/8

Cordis S.M.A.R.T.™ CONTROL™ Stents


C06030MV 6 30 6/8

C06040MV 6 40 6/8

C06060MV 6 60 6/8

C06080MV 6 80 6/8

C06100MV 6 100 6/8

C07030MV 7 30 6/8

C07040MV 7 40 6/8

C07060MV 7 60 6/8

C07080MV 7 80 6/8

C07100MV 7 100 6/8

C08030MV 8 30 6/8

C08040MV 8 40 6/8

C08060MV 8 60 6/8

C08080MV 8 80 6/8

C08100MV 8 100 6/8

C09030MV 9 30 6/8

C09040MV 9 40 6/8

C09060MV 9 60 6/8

C09080MV 9 80 6/8

C10030MV 10 30 6/8

C10040MV 10 40 6/8

C10060MV 10 60 6/8

C10080MV 10 80 6/8

Important InformationPrior 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 re-serve the right to change product specifications without prior notification. For healthcare professionals only.

© 2017 Cardinal Health. All Rights Reserved. CORDIS, Cordis LOGO and S.M.A.R.T CONTROL are trademarks of Cardinal Health and may be registered in the US and/or in other countries. EU2370 06/17.

when outcomes matter, design matters - cordis · design matters for superficial femoral artery...

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