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N A V I G A T E T O U G H A N A T O M Y

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The CODMAN ENTERPRISE™ Vascular Reconstruction Device and Delivery System

Navigate with precision & Confidence

®

Ease of UseThe stent is pre-loaded onto a delivery systemcomposed of an introducer and a delivery wire for a simple system confi guration. After microcatheter is in place, access, advance, position and deploy stent. Wire access is maintained post-deployment.

Precise PlacementCODMAN ENTERPRISE™ Vascular Reconstruction Device can be partially deployed within the parent artery, then recaptured once and redeployed if needed.

Excellent Wall AppositionHighly fl exible closed cell design provides conformability and true vessel reconstructionat neck of the aneurysm. Flared ends contribute to conformability and facilitate re-access through the stent.

Outstanding CoilMass SupportClosed cell stent design provides advanced scaffold for outstanding coil mass support.

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Key Features

Stent Markers4 radiopaque markers on proximal & distal ends of the stent for increased visibility.

Stent Positioning MarkerRadiopaque delivery wire marker runs the length of the stent for precise placement.

Flared EndsDesigned for excellent wall apposition and

conformability. Facilitates re-access through stent.

Delivery WireA core wire with varying zones of fl exibility to facilitate navigation through neurovasculature. Wire access is maintained post-deployment.

Closed Cell DesignHighly fl exible closed cell stent design for conformability, recapturability, and true vessel reconstruction at the neck of the aneurysm. Designed to provide advanced scaffold

for coil mass support.

Lubricious CoatingOur proprietary stent coating may facilitate stent tracking through the microcatheter.

Recapturable StentSystem design allows stent to be recaptured and redeployed once to facilitate precise placement.

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Easy-to-use Confi guration

Step 1: Access Aneurysm Site with MicrocatheterGain vascular access according to standard

practice and access aneurysm site with

a microcatheter.

Step 2: Advance Stent Delivery SystemFlush device. Seat the introducer in the

catheter hub. Advance stent system

through microcatheter.

Step 3: Position & Deploy (Recapture & Reposition)Position the stent by aligning the stent positioning

marker of delivery wire with the target site.

Unsheath to deploy. Recapture and reposition,

once if necessary, before deployment.

Stent is pre-loaded onto a delivery system composedof an introducer and a delivery wire.

NOTE: Please refer to “Instructions for Use” prior to use of the product.

Step 4: Coil AneurysmProceed with coiling procedure through

stent cells according to the coil

“Instructions for Use”.

Four quick & easy steps to deploy the CODMAN ENTERPRISE™ VASCULAR RECONSTRUCTION DEVICE

Essential Attributes

Closed Cell

Open Cell

Precise PlacementStent positioning marker clearly

identifi es stent location.

Excellent Wall AppositionClosed cell design for conformability and true vessel reconstruction at the neck of the aneurysm.

The fl ared ends of the stent are designed to enhance

apposition of the implanted stent to the wall of the

vessel and to facilitate re-access through the stent.

Results of in-vivo chronic animal evaluation study

demonstrates CODMAN ENTERPRISE™ Vascular

Reconstruction Device can be accurately positioned across

the neck of an aneurysm and completely endothelialized

within 30 days.2

1 As assessed angiographically by independent core lab (US Clinical Trial Report, n=28).

2 Enterprise Chronic Animal Study Final Report, (n=7).

Image from chronic animal study

Outstanding Coil Mass SupportClosed cell stent design provides advanced

scaffold for outstanding coil mass support.

Animal explants and feasibility clinical

trial experience show that the CODMAN

ENTERPRISE™ Vascular Reconstruction

Device satisfactorily maintains the coil

mass deposited within the aneurysm.1, 2

Can be deployed and recaptured once, if necessary.

Endothelial Coverage

Stent Struts

ICES (Interstate Collaboration ofENTERPRISE™ Stent/coiling) Registry initial results 1

• Collaborative (physician-initiated) registry

• 10 institutions presented their initial consecutive experience with the CODMAN ENTERPRISE™ VRD

• 141 patients, 142 treated aneurysms, 143 attempted stent deployments

• RESULTS:

- High aneurysm obliteration

• Greater than or equal to 90% obliteration was reported in 76% of aneurysms that were coiled

- High rate of successful vessel navigation and accuracy of deployment

• Stent was successfully deployed in 97% of cases

- Low morbidity, low mortality

• 2.8% permanent morbidity, 2% mortality

Angiographic images from U.S. clinical trial.

Case 2Case 1

Selected Clinical Cases

Pre-Embolization Post-Embolization Pre-Embolization Post-Embolization

Clinical Experience

PROWLER® SELECT® Plus Microcatheter is the only microcatheter tested for compatibility with the CODMAN ENTERPRISE™ Vascular Reconstruction Device. The CODMAN ENTERPRISE™ Vascular Reconstruction Device requires a 0.021” microcatheter inner diameter.

Diameter (mm)

Length (mm)

Recommended Parent Vessel Diameter (mm)

4.5

4.5

4.5

4.5

14

22

28

37

2.5 - 4

2.5 - 4

2.5 - 4

2.5 - 4

Catalog Codes

ENF451412

ENF452212

ENF452812

ENF453712

CODMAN ENTERPRISE™ Vascular Reconstruction Device

606-S255X

606-S255FX

606-S255MX

606-S255JX

Straight

45

90

J

2.8F/2.3F

2.8F/2.3F

2.8F/2.3F

2.8F/2.3F

0.021

0.021

0.021

0.021

150

150

150

150

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5

5

5

2

2

2

2

Product Specifi cations

Microcatheter Compatibility

Product Information

PROWLER® SELECT® Plus Microcatheters

Catalog Codes

Shape Tip MarkersOD (prox./distal) ID (inches) Usable Length (cm)

Distal Length

(cm)

Ease of Use

Precise Placement

Excellent Wall Apposition

Outstanding Coil Mass Support

325 Paramount Dr.

Raynham, MA 02767

For Customer Service in the U.S.A. Call: 1-800-255-2500

www.codman.com

Important Information: Prior to use, refer to “Instructions for Use” supplied with these devices for indications, contraindications, side effects, suggested procedures, warnings, and precautions.

Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician. See package insert for full product information.

HUMANITARIAN DEVICE (USA ONLY): The CODMAN ENTERPRISE™ Vascular Reconstruction Device and Delivery System is authorized by Federal Law for use with embolic coils for the treatment of wide-neck, intracranial, saccular or fusiform aneurysms arising from a parent vessel with a diameter of > 2.5 mm and < 4 mm. Wide-neck is defined as having a neck width > 4 mm or a dome-to-neck ratio < 2. The effectiveness of this device for this use has not been demonstrated.

© 2009 Codman & Shurtleff, Inc. CODMAN ENTERPRISE™ and PROWLER® SELECT® are trademarks of Codman & Shurtleff, Inc. Codman Neurovascular is a business unit of Codman & Shurtleff, Inc.

ENT-07-001

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