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


Navigate with
precision & Confidence
The CODMAN ENTERPRISE™ Vascular Reconstruction Device and Delivery System

Ease of Use
The stent is pre-loaded onto a delivery system
composed of an introducer and a delivery
wire for a simple system configuration. After
®
microcatheter is in place, access, advance,
position and deploy stent. Wire access is
maintained post-deployment.

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

Excellent Wall Apposition


Highly flexible closed cell design provides
conformability and true vessel reconstruction
at neck of the aneurysm. Flared ends
contribute to conformability and facilitate
re-access through the stent.

Outstanding Coil
Mass Support
Closed cell stent design provides advanced
scaffold for outstanding coil mass support.
Key Features

1 Stent Markers
4 radiopaque markers on proximal & distal ends
of the stent for increased visibility.

2 Stent Positioning Marker


Radiopaque delivery wire marker runs the length
of the stent for precise placement.

3 Flared Ends
Designed for excellent wall apposition and
1
4
conformability. Facilitates re-access through stent.

3
4 Delivery Wire
A core wire with varying zones of flexibility to
facilitate navigation through neurovasculature.
Wire access is maintained post-deployment.

2
5
5 Closed Cell Design
Highly flexible 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.

6 Lubricious Coating
7 Our proprietary stent coating may facilitate
stent tracking through the microcatheter.

7 Recapturable Stent
System design allows stent to be recaptured
and redeployed once to facilitate
precise placement.
Easy-to-use Configuration

Four quick & easy steps to deploy the


CODMAN ENTERPRISE ™ VASCULAR RECONSTRUCTION DEVICE

Stent is pre-loaded onto a delivery system composed


of an introducer and a delivery wire.

Step 1: Access Aneurysm Site Step 2: Advance Stent


with Microcatheter Delivery System
Gain vascular access according to standard Flush device. Seat the introducer in the
practice and access aneurysm site with catheter hub. Advance stent system
a microcatheter. through microcatheter.

Step 3: Position & Deploy Step 4: Coil Aneurysm


(Recapture & Reposition) Proceed with coiling procedure through
Position the stent by aligning the stent positioning stent cells according to the coil
marker of delivery wire with the target site. “Instructions for Use”
.
Unsheath to deploy. Recapture and reposition,
once if necessary, before deployment. NOTE: Please refer to “Instructions for Use”
prior to use of the product.
Essential Attributes

Precise Placement
Stent positioning marker clearly
identifies stent location.

Outstanding Coil
Mass Support
Closed cell stent design provides advanced
scaffold for outstanding coil mass support.

Animal explants and feasibility clinical


trial experience show that the CODMAN
Closed Cell
ENTERPRISE™ Vascular Reconstruction

Excellent Wall Apposition Device satisfactorily maintains the coil


mass deposited within the aneurysm.1, 2
Closed cell design for conformability and true vessel
reconstruction at the neck of the aneurysm.
The flared 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.

Open Cell
Stent Struts

Endothelial Coverage
Can be deployed and
recaptured once, if necessary.

Image from chronic animal study

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 1
As assessed angiographically by independent core lab (US Clinical Trial Report, n=28).
within 30 days.2 2
Enterprise Chronic Animal Study Final Report, (n=7).
Clinical Experience

ICES (Interstate Collaboration of


ENTERPRISE ™ 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

Selected Clinical Cases


Case 1 Case 2

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

Angiographic images from U.S. clinical trial.


Product Information

Product Specifications
CODMAN ENTERPRISE ™ Vascular Reconstruction Device
Catalog Diameter Length Recommended
Codes (mm) (mm) Parent Vessel Diameter (mm)

ENF451412 4.5 14 2.5 - 4

ENF452212 4.5 22 2.5 - 4

ENF452812 4.5 28 2.5 - 4


ENF453712 4.5 37 2.5 - 4

Microcatheter Compatibility
PROWLER ® SELECT ® Plus Microcatheters
Catalog Shape OD (prox./distal) ID (inches) Usable Length Distal Length Tip Markers
Codes (cm) (cm)

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

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

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


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

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.
325 Paramount Dr.
Raynham, MA 02767
For Customer Service in the U.S.A. Call: 1-800-255-2500
www.codman.com

Ease of Use
Precise Placement
Excellent Wall Apposition
Outstanding Coil Mass Support

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.

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.

© 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