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NAVIGATE WITH PRECISION, CONFIDENCE and CONFORMABILITY

NAVIGATE WITH PRECISION, CONFIDENCE and CONFORMABILITYsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · 2. Enhanced closed cell design The closed cells were

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Page 1: NAVIGATE WITH PRECISION, CONFIDENCE and CONFORMABILITYsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · 2. Enhanced closed cell design The closed cells were

NAVIGATE WITH PRECISION, CONFIDENCE and CONFORMABILITY

Page 2: NAVIGATE WITH PRECISION, CONFIDENCE and CONFORMABILITYsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · 2. Enhanced closed cell design The closed cells were

1. Stent Positioning Marker A fluoroscopic guide helps provide precise deployment

at the aneurysm neck

2. Enhanced closed cell design The closed cells were redesigned allowing the stent

to better expand and contract in vessel tortuosity, optimizing wall apposition

3. Recapturable stent The closed cell design allows for deployment and

recapture, facilitating precise placement

4. .021” Microcatheter delivery Allowing easy, precise navigation 99.8% of the time1

5. Stent markers New solid platinum stent markers with increased

radiopacity provide clear visibility of the device during and after deployment

1

1

2

3

4

5

2

3

4

5

KEY FEATURES

2. Codman Neuro Enterprise® 2 Vascular Reconstruction Device

1King B, et al. J NeuroIntervent Surg 2014;0:1–5. doi:10.1136/neurintsurg-2014-011457(Data in this study is based on experience with the original CODMAN ENTERPRISE® Vascular Reconstruction Device).

Page 3: NAVIGATE WITH PRECISION, CONFIDENCE and CONFORMABILITYsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · 2. Enhanced closed cell design The closed cells were

ENHANCED CONFORMABILITY

3.Codman Neuro Enterprise® 2 Vascular Reconstruction Device

Allows the stent to elongate on the outside radius of the bend

Allows the stent to compress on the inside radius of the bend

Variable strut width allows easy navigation and conformability

Enhanced closed cell design

Based upon the principles of the original CODMAN ENTERPRISE® stent design, the CODMAN ENTERPRISE® 2 Vascular Reconstruction Device has been enhanced to improve conformability and wall apposition while maintaining the significant benefits of its closed cell design.

Images courtesy of Dr. Masahiro Yoshida, Osaki Citizen Hospital, Japan

Pre treatment: Unruptured Basilar Tip Aneurysm

Pre Treatment: Unruptured ICA Aneurysm

CODMAN ENTERPRISE® 2 deployed

CODMAN ENTERPRISE® 2 deployed

Page 4: NAVIGATE WITH PRECISION, CONFIDENCE and CONFORMABILITYsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · 2. Enhanced closed cell design The closed cells were

OUTSTANDING COIL MASS SUPPORT

The CODMAN ENTERPRISE® 2 Stent has the highest point load force measurements, demonstrating its ability to effectively support the coil mass.

Advanced closed cell stent designThe CODMAN ENTERPRISE® and CODMAN ENTERPRISE® 2 Vascular Reconstruction Devices were designed to better approximate the aneurysm neck and reduce the likelihood of coil compartmentalization and herniation into the lumen.

Point Load Force

1King B, et al. J NeuroIntervent Surg 2014;0:1–5. doi:10.1136/neurintsurg-2014-011457(Data in this study is based on experience with the original CODMAN ENTERPRISE® Vascular Reconstruction Device).2Codman Neuro internal testing report 103111155.

4. Codman Neuro Enterprise® 2 Vascular Reconstruction Device

Point Load Force2

Forc

e (g

)

25

20

15

10

5

0ENTERPRISE® ENTERPRISE® 2 Neuroform™ Solitaire™ Lvis® Jr

Studies support higher complete occlusion rates and lower recanalization rates compared to Neuroform.1

CODMAN ENTERPRISE® 2 (closed cell design) Neuroform™ (open cell design)

POIN

T LO

AD

Page 5: NAVIGATE WITH PRECISION, CONFIDENCE and CONFORMABILITYsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · 2. Enhanced closed cell design The closed cells were

PRECISE AND STABLE PLACEMENT

Minimal foreshortening The CODMAN ENTERPRISE® Stent deploys with minimal foreshortening4.

Stent Positioning Marker The CODMAN ENTERPRISE® Stent Positioning Marker helps position the stent precisely at the neck of the aneurysm.

Stable placement Chronic Outward Force (COF) may help the stent resist migration.

3 % foreshortening calculated from data in Lvis™/ Lvis™ Jnr Intraluminal Support Device Instructions for Use 2014-064 Codman Neuro internal testing report 103111155* Images above table from Codman Neuro internal testing report 103111155

5.Codman Neuro Enterprise® 2 Vascular Reconstruction Device

Chronic outward force4

Pres

sure

(m

mH

g)

30

25

20

15

10

5

0

ENTERPRISE® 2ENTERPRISE® Neuroform™ Solitaire™ 2/FR Lvis® Jr

CODMAN ENTERPRISE®

Stent positioning marker

NEUROFORM

No stent positioning

marker

Stent Positioning

Marker

23mm CODMAN ENTERPRISE® Device

23mm LVIS® Jr.

undeployed

undeployed

1.2mm

or

4.9%

6mm

or

19%3

Deployed

3mm dia.

Deployed

3mm dia.

Page 6: NAVIGATE WITH PRECISION, CONFIDENCE and CONFORMABILITYsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · 2. Enhanced closed cell design The closed cells were

PROVEN CLINICAL PERFORMANCE

A literature review representing the largest and most robust comparison of stent assisted coiling to

date, reports better performance of the CODMAN ENTERPRISE® Vascular Reconstruction Device. The CODMAN ENTERPRISE® VRD provides reliable performance that you can trust.

Source: King B, et al. Journal of Neuro-Interventional Surgery 2014; 0:1–5. doi:10.1136/neurintsurg-2014-011457(Data in this study is based on experience with the original ENTERPRISE® stent)

6. Codman Neuro Enterprise® 2 Vascular Reconstruction Device

80,0%

75,0%

70,0%

65,0%

60,0%

55,0%

50,0%

74,7%

61,1%

ENTERPRISE® NEUROFORM™

Complete Occlusion of the aneurysm at last follow-up (p < 0,001)

4,0%

3,0%

2,0%

1,0%

0,0%

1,6%

3,4%

ENTERPRISE® NEUROFORM™

Lower rates of ICH (P=0.001)

16,0%

12,0%

8,0%

4,0%

0,0%

10,6%

13,9%

ENTERPRISE® NEUROFORM™

Lower rates of recanalization (P = 0.02)

Higher rates of complete occlusion (P<0.001)

Page 7: NAVIGATE WITH PRECISION, CONFIDENCE and CONFORMABILITYsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · 2. Enhanced closed cell design The closed cells were

PROVEN CLINICAL PERFORMANCE

* TE events defined as TIA stroke, or development of asymptomatic thrombus during procedure.(Data in this study is based on experience with the original ENTERPRISE® stent)

7.Codman Neuro Enterprise® 2 Vascular Reconstruction Device

100,0%

80,0%

60,0%

40,0%

20,0%

0,0%

99,8% 97,7%

ENTERPRISE® NEUROFORM™

7%

6%

5%

4%

3%

2%

1%

0%

5,9% 6,7%

ENTERPRISE® NEUROFORM™

1,2%

1,0%

0,8%

0,6%

0,4%

0,2%

0,0%

1,0% 1,2%

ENTERPRISE® NEUROFORM™

Higher rates of deployment success (P<0.001)

Lower rates of thromboembolic events* (P=0.37)

Lower rates of in-stent stenosis (P=0.75)

47 peer-reviewed studies

4,238 aneurysms

4,039 patients

14.1 months mean follow-up

Studies from 2004 through March, 2014

Page 8: NAVIGATE WITH PRECISION, CONFIDENCE and CONFORMABILITYsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · 2. Enhanced closed cell design The closed cells were

IMPROVED EASE OF USE

Recapturability The closed cell design of the CODMAN ENTERPRISE® stent / ENTERPRISE® 2 stent allows you to deploy and recapture with confidence for when you need that second chance.

CODMAN ENTERPRISE®

Stent

NEUROFORM

Stent

CODMAN ENTERPRISE® Stent CODMAN ENTERPRISE® 2 Stent

Improved Stent markersNew solid platinum markers provide increased radiopacity during and after deployment.

Fully insert the introducer and flush simultaneously

Heparinized saline enters through these holes

Saline exits here

• Self-flushing introducer facilitates ease of use • Tapered distal end to match PROWLER SELECT® Plus Microcatheter

New Self Flushing Introducer

8. Codman Neuro Enterprise® 2 Vascular Reconstruction Device

Page 9: NAVIGATE WITH PRECISION, CONFIDENCE and CONFORMABILITYsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · 2. Enhanced closed cell design The closed cells were

© C

od

man

Neu

ro,

a d

ivis

ion

of

Joh

nso

n &

Jo

hn

son

Med

ical

Lim

ited

201

5.

All

rig

hts

res

erve

d.

DSE

M/C

OD

/021

6/0

174

Codman Neuro is a trading division of Johnson & Johnson Medical Ltd.Registered Office: PO Box 1988, Simpson Parkway, Livingston, West Lothian, EH54 0AB, Registered in Scotland, No.SC 132162 This publication is not intended for distribution in the USA.

Johnson & Johnson Medical Ltd. Pinewood Campus, Nine Mile Ride Wokingham, RG40 3EW United Kingdom

Medos International SARLChemin-Blanc 38 CH-2400 LeLocle Switzerland

Codman NeuroScience SARLRue Girardet 29 CH-2400 LeLocle Switzerland

Products may be manufactured at one of the following: Codman & Shurtleff, Inc.325 Paramount DriveRaynham, MA 02767-0350USA

www.depuysynthes.com

Over 110,000 CODMAN ENTERPRISE® Stent units have been distributed globally since 2006*.

PROWLER SELECT Plus Microcatheter is the only microcatheter tested for compatibility with the CODMAN ENTERPRISE® 2 Stent. The CODMAN ENTERPRISE® 2 Stent requires a 0.021” microcatheter inner diameter.*Codman shipment data as per 30/10/2015

MICROCATHETER COMPATIBILITY

PRODUCT SPECIFICATIONS

PROWLER SELECT® Plus Microcatheters

Catalog Codes Shape OD (prox./distal)

ID (inches)

Usable Length (cm)

Distal Length (cm)

Tip Markers

606S255X Straight 2.8F/2.3F 0.021 150 5 2

606S255FX 45 2.8F/2.3F 0.021 150 5 2

606S255MX 90 2.8F/2.3F 0.021 150 5 2

606S255JX J 2.8F/2.3F 0.021 150 5 2

CODMAN ENTERPRISE® 2 Vascular Reconstruction Device

Distal TipCatalog Code

No Distal TipCatalog Code

Min. Indicated Parent Vessel Diameter (mm)

Max. Indicated Parent Vessel Diameter (mm)

Length at Max Indicated Parent Vessel Diameter

ENC401612 ENC401600 2.0 4.0 16

ENC402312 ENC402300 2.0 4.0 23

ENC403012 ENC403000 2.0 4.0 30

ENC403912 ENC403900 2.0 4.0 39