DuraMatrix portfolio. Restore with confidence

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DuraMatrix portfolio Restore with confidence

History Since 2003, Stryker has partnered with Collagen Matrix, Inc. to provide our customers with quality products that are safe and effective in the restoration of the dura mater. Collagen Matrix, founded in 997 by Shu-Tung Li, Ph.D., who has over 40 years of exience in connective tissue research and collagen based implant development, delivers a full line of the highest quality collagen and mineral based medical devices that support the body s natural ability to regenerate. The Company currently produces finished medical devices in the areas of Dental, Neurosurgical, Spine, Orthopaedic and Nerve Repair Surgery. DuraMatrix line products are comprised of Type I collagen and intact dermis tissue derived from a bovine source and a strict closed herd system to ensure safety and quality.

DuraMatrix-Onlay PLUS Collagen dura regeneration matrix highly conformable and sutureless restoration DuraMatrix-Onlay PLUS is derived from purified, bovine Achilles tendon. It is intended for use as a dura substitute for the repair of dura mater. In addition to the thick, spongy texture, this fourth generation DuraMatrix product has a non-porous, collagen layer. This layer helps produce a lower liquid meability rate compared to that of DuraGen Plus as shown in a bench test., 3 DuraMatrix-Onlay PLUS offers a balanced resorbtion profile that occurs over approximately 8 weeks. 2, 3 Liquid meability (ml/min/cm 2 ),3 DuraMatrix-Onlay PLUS DuraGen Plus 0.0±0.007 0.558±0.09 For more information on DMOP or to view the leakage test video, scan here 50x, 2, 3 lower liquid meability rate than DuraGen Plus Non-porous, collagen layer (smooth side) Sponge layer Approx. 3.5 mm thick

DuraMatrix Suturable Collagen dura membrane reinforced and reliable DuraMatrix Suturable is a collagen dura membrane from purified intact bovine dermis tissue. It is intended for use as a dura substitute for the repair of dura mater. The natural crosslinks inherent in the native bovine collagen are further biochemically reinforced through a proprietary crosslinking process to provide you with the strength you need. Furthermore, this results in a resorption time of 38-40 weeks based on the results of a rabbit duraplasty model, 2, 3 while new dura mater is regenerated to replace the membrance. Suture pull out strength (N),3 DuraMatrix Suturable Durepair 20.40±.54 N.67±4.2 N DuraMatrix Suturable shows significantly higher suture pull out strength compared to Durepair., 3 This mits the graft to be firmly anchored to surrounding tissue with minimal risk of membrane tear or detachment. 74.8 % greater suture pullout strength than Durepair The total resorption time (defined as <5% implant remaining) is approximately 38-40 weeks for DuraMatrix Suturable and approximately 20-22 weeks for Durepair. 2,3

DuraMatrix-Onlay Collagen dura membrane, onlay conformable and versatile DuraMatrix Collagen dura substitute membrane strong and conformable DuraMatrix-Onlay is a purified, type I collagen membrane derived from bovine Achilles tendon. It is intended for use as a dura substitute for the repair of dura mater. DuraMatrix is a purified, type I collagen membrane derived from bovine Achilles tendon. It is intended for use as a dura substitute for the repair of dura mater. With a thickness of about 0.6mm, DuraMatrix-Onlay serves as a thinner onlay option than DuraMatrix-Onlay PLUS. The graft can also be applied with minimal tension sutures if desired. DuraMatrix-Onlay offers a balanced resorption that occurs over 6-9 months. 2, 3 DuraMatrix has a thickness of about 0.3 mm which can be considered similar to the thickness of native dura. The unique conformability proties of the membrane combined with its mechanical strength allow DuraMatrix to be applied as either an onlay membrane or sutured in place. DuraMatrix offers a balanced resorption that occurs over 6-9 months. 2, 3

4" (0cm) 7" (7.5cm) 3" (7.5cm) " (2.5cm) 3" (7.5cm) 5" (2.5cm) 5" (2.5cm) 2" (5cm) 3" (7.5cm) " (2.5cm) 2" (5cm) " (2.5cm) DuraMatrix- Onlay PLUS DuraMatrix Suturable DuraMatrix- Onlay DuraMatrix DMOP in x in DMS in x in CDSLM in x in CDSM in x in DMOP3 in x 3 in DMS3 in x 3 in CDSLM3 in x 3 in CDSM3 in x 3 in DMOP22 DMS22 CDSLM22 CDSM22 DMOP33 DMS33 CDSLM33 CDSM33 DMOP45 (0 cm x 2.5 cm) DMS45 (0 cm x 2.5 cm) CDSLM45 (0 cm x 2.5 cm) CDSM45 (0 cm x 2.5 cm) DMOP57 5 in x 7 in CDSLM57 5 in x 7 in Craniomaxillofacial 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 is intended to demonstrate the breadth of Stryker product offerings. A surgeon must always refer to the package insert, product label and/or instructions for use before using any Stryker product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area. Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: Stryker. All other trademarks are trademarks of their respective owners or holders. Durepair is a registered trademark of TEI Biosciences Inc. DuraGen is a registered trademark of Integra Lifesciences Corporation DuraMatrix-Onlay PLUS and DuraMatrix Suturable are trademarks of Collagen Matrix, Inc. DuraMatrix-Onlay and DuraMatrix are registered trademarks of Collagen Matrix, Inc. DuraMatrix-Onlay PLUS, DuraMatrix Suturable, DuraMatrix-Onlay and DuraMatrix are manufactured by Collagen Matrix, Inc., Oakland, New Jersey USA. Distributed by: Stryker Craniomaxillofacial Kalamazoo, MI 49002 USAt: 269 389 5346 toll free: 800 962 6558 f: 877 648 74 www.stryker.com CMF-BR-75_Rev. None_2764 UnDe/P.S. Copyright 206 Stryker Printed in USA References:. In vitro data on file at Collagen Matrix, Inc. 2. Rabbit duraplasty study. Data on file at Collagen Matrix inc. 3. The results of preclinical in vitro studies may not be indicative of human clinical outcomes In vivo evaluation of resorption in a rabbit duraplasty model. Data on file.