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 Boetzinger Strasse 41 D-79111 Freiburg Germany Phone: +49 (0) 7 61 45 12-0 Fax: +49 (0) 7 61 45 12-120 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 0086
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