When Outcomes Matter, Design Matters - Cordis · Design Matters For superficial femoral artery...
Transcript of 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
to receive our latest news and key acti
vitie
s.
Follo
w us on CORDIS EMEA
LinkedIn page
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
120 cm Delivery Expanded Stent Expanded Stent Profile: Sheath/ System Diameter (mm) Length Guide Fit (F)
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
80 cm Delivery Expanded Stent Expanded Stent Profile: Sheath/ System Diameter (mm) Length Guide Fit (F)
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
120 cm Delivery Expanded Stent Expanded Stent Profile: Sheath/ System Diameter (mm) Length Guide Fit (F)
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
80 cm Delivery Expanded Stent Expanded Stent Profile: Sheath/ System Diameter (mm) Length Guide Fit (F)
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
120 cm Delivery Expanded Stent Expanded Stent Profile: Sheath/ System Diameter (mm) Length Guide Fit (F)
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.