Craniomaxillofacial
DuraMatrix
Collagen Dura Substitute
Membrane
• Onlay or Sutured Implantation
• Excellent Handling Characteristics
• Strong and Conformable
• Balanced Resorption
• Watertight Material
• Highly Purified Type I Collagen
DuraMatrix
DuraMatrix represents the next generation in dural
substitute technology.
Indication
DuraMatrix is indicated for use as a dural substitute for the repair of dura mater.
Product Overview
DuraMatrix is a conformable and resorbable membrane matrix engineered from
highly purified type I collagen. DuraMatrix is designed with a thickness similar
to that of native dura. DuraMatrix has excellent handling characteristics,
is flexible and conforms to the contour of the defect.
The unique conformability properties of the membrane combined with its
mechanical strength allow DuraMatrix to be applied as either an onlay membrane
or sutured in place. In a large scale animal study1 and clinical study2, DuraMatrix
was shown to facilitate healing with balanced in vivo resorption of the implant
and regeneration of host tissue.
Advantages
•
•
•
•
Histological evidence of DuraMatrix partially
resorbed and being replaced with new tissue
twelve weeks post-operative, Trichome, mag. x 40
Onlay or Sutured Implantation
Balanced Resorption
Highly Purified Type I Collagen
Excellent Handling Characteristics
Conformable
Strong
2
Watertight
Animal Model
Summary of Animal Duraplasty Model1 (Fig.1)
At 12 weeks, it was observed that there was negligible adhesion of the implants to
the underlying cortex of the brain, and that the dural defects were completely or
almost completely repaired. There was complete or nearly complete incorporation
of DuraMatrix with the native dura at the edges of the defects.
No white blood cells were found in the cerebral spinal fluid at 12 weeks
after implantation.
Under the microscope, at 12 weeks there was approximately 40% of the implant
remaining, which was balanced with the regeneration of new tissue. Evaluation of
gross and microscopic data for sutured and non-sutured DuraMatrix at 2, 7, and
12 weeks showed no significant difference. Under the microscope and in agreement
with gross observations, DuraMatrix exhibited negligible adhesion to the cortex,
but good anchorage to the native dura at the edges of the defects. By 12 weeks, host
fibroblasts had invaded the implants and produced new collagen as DuraMatrix
was resorbed. Neovascularization of the dura substitute was evident.
Inflammatory changes or foreign body responses were minimal.
Fig.1
1. Ulreich JB and Hamilton AJ. ID Number 02-6-1. In Vivo Evaluation of DuraMatrix Dura Substitute. The University
of Arizona Health Sciences Center.
2. Grotenhuis JA. Clinical Investigation. Verification of Safety and Performance of DuraMatrix Collagen Dura
Substitute Membrane. Radboud University Medical Center.
Ordering Information
DuraMatrix images are not shown in their actual size (scale 1:1)
REF
CDSM11
2.5 cm x 2.5 cm
CDSM13
2.5 cm x 7.5 cm
CDSM22
5.0 cm x 5.0 cm
CDSM33
7.5 cm x 7.5 cm
CDSM45
10.0 cm x 12.5 cm
CDSM13
CDSM22
CDSM33
CDSM11
CDSM13
CDSM11
CDSM45
3
Description
Trauma, Extremities & Deformities
Biologics
Surgical Products
Neuro & ENT
Distributed by
Stryker Leibinger GmbH & Co. KG
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D-79111 Freiburg
Germany
Phone: +49 (0) 7 61 45 12-0
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This document is for internal use only. It is not intended for general distribution or dissemination outside Stryker
premises. A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a
particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that
surgeons be trained in the use of any particular product before using it in surgery. The information presented in this
brochure is intended to demonstrate a Stryker product. Always refer to the package insert, product label and/or user
instructions including the instructions for Cleaning and Sterilization (if applicable) before using any Stryker products.
Products may not be available in all markets. Product availability is subject to the regulatory or medical practices that
govern individual markets. Please contact your Stryker representative if you have questions about the availability of
Stryker products in your area. This document is not for the distribution in the USA.
www.stryker.com
Manufactured by
Collagen Matrix, Inc.
15 Thornton Road
Oakland, NJ 07436 USA
www.collagenmatrix.com
Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following
tradmarks or service marks: Stryker, Leibinger.
Collagen Matrix, Inc. owns the following trademarks:
DuraMatrix™.
All other trademarks are trademarks of their respective owners or holders.
The products listed above are CE marked.
Literature Number 90-01605
LOT C2811
Copyright © 2011 Stryker
Printed in the USA
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