strength of science Now with sizes up to 25 cm x 45 cm XCM BIOLOGIC Tissue Matrix
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1 strength of science XCM BIOLOGIC Tissue Matrix Now with sizes up to 25 cm x 45 cm Your trusted partner providing a complete portfolio of biologic meshes.
2 DePuy Synthes Companies of Johnson & Johnson offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological medicine, craniomaxillofacial surgery, power tools, and biomaterials.
3 Indications XcM BioLogic tissue Matrix is indicated for use in general surgical procedures for the reinforcement and repair of soft tissue where weakness exists, including, but not limited to; defects of the thoracic wall, suture line reinforcement, and muscle flap reinforcement; hernia repair; soft-tissue reconstructive procedures including plastic and reconstructive surgical applications; and for reinforcement of soft tissues, which are repaired by suture or suture anchors. XcM BioLogic tissue Matrix is intended for single-use only. Contraindications this device is derived from a porcine source and should not be used for patients with known sensitivity to porcine material. the device is contraindicated for patients known to be undergoing desensitization injections to meat products, as these injections can contain porcine collagen. the device is contraindicated for use in any patient in whom soft-tissue implants are contraindicated, including: Blood supply limitations Pathologic soft-tissue conditions that would prevent secure fixation soft-tissue reinforcement Defects of thoracic Wall the device is contraindicated in uses that require rolling, folding, or layering, and which may create a space impermeable to fluid, cells, and blood vessels. such uses may result in excessive inflammation, drainage, extrusion, or infection. folding of the product edges (1 cm or less) to increase suture retention strength has not resulted in any reported problems in similar products, and is appropriate when indicated. the device is contraindicated for patients with severe allergies manifested by a history of anaphylaxis, history of multiple severe allergies, or known allergies against porcine collagen. Please refer to the package insert for full list of indications, contraindications, warnings, and/or precautions. hernia repair Plastic and reconstructive surgeries
4 Key features Easy-to-use hydrated, ready-to-use no soaking reduces the chances of contamination can be stored at room temperature no pre-stretching required no orientation limitation terminally sterilized no risk of human disease transmission Available in a wide variety of sizes Strong strength without cross-linking intact collagen fibers retain natural strength and provide pliability to XcM BioLogic tissue Matrix** highly consistent thickness Non-cross-linked Unique processing maintains the natural 3-D fibrous structure and key ecm components* open pore structure allows for cell in-growth and revascularization** 6 Our partnership with DSM brings you more than 20 years of experience with biologic materials. scan the Qr code to see how XcM BioLogic tissue Matrix open-pore structure allows blood to permeate through it. * the effect of these components on the performance of XcM BioLogic tissue Matrix has not been clinically evaluated. ** Data on file at DsM. Animal and bench test results are not necessarily indicative of clinical performance.
5 For DePuy Synthes Companies, quality is the top priority. We have partnered with DSM, which produces XCM BIOLOGIC Tissue Matrix through its innovative Optrix TM process. Optrix TM maintains natural collagen architecture without cross-linking*. Meticulously tested Shown: Large sizes of XCM BIOLOGIC Tissue Matrix being tested at DSM. Each piece is individually tested*. *Data on file at DSM.
6 optrix tm Process strong, selective, and gentle Strong enough to disinfect tissue and inactivate viruses* Achieves a sterilization Assurance Level (sal) of 10-6 for bacteria, mold, and yeast. inactivation and clearance of a biologically diverse range of viruses, including the highly resistant small non-enveloped viruses. Selective enough to remove unwanted cells* the optrix tm process reduces the cellular material in XcM BioLogic tissue Matrix to background levels of residual DnA as measured by Pico green testing. it also reduces the α-galactose antigen level for better host acceptance*. DnA concentration of biologic tissue matrices ng/mg 0 XCM BIOLOGIC Strattice Raw Dermis Surgisis Tissue Matrix results of Pico green Assay Presence of post-processing glycosaminoglycans (gags)* Gentle enough to maintain bulk of natural ECM components* the optrix tm process retains a high percentage of glycosaminoglycans (gags)*. in vivo, gags mediate cell communication during tissue repair. % of raw tissue 90% 80% 70% 60% 50% 40% 30% 20% 0% XCM BIOLOGIC Surgisis Strattice Tissue Matrix n=28 n=4 n=3 note: XcM BioLogic tissue Matrix, surgisis, strattice, and raw dermis (4.3 µg/mg) measured by DsM. raw sis (21µg/mg) from hodde et. al., tiss eng 2(3): *Data on file at DsM. the effect of these components on the performance of XcM BioLogic tissue Matrix has not been clinically evaluated.
7 science that matters to you Key molecular components* in a biologic tissue matrix Tensile strength structural proteins like collagen provide strength and structural support in the body. XcM BioLogic tissue Matrix is a non-cross-linked matrix. it maintains types 1, 3, 4, and 7 collagen* 1. Suture retention strength Retention of key molecular components: GAGs glycosaminoglycans (gags) mediate cell communication, sequester water for structural support, and play an important role in the body during tissue repair 2. XcM BioLogic tissue Matrix is proven to retain high levels of gags compared to its competitors*. Incorporation glycoproteins such as fibronectin and laminin promote cell attachment 3. fibronectin plays a vital role in vivo during cell adhesion, cell differentiation, and tissue reconstruction 4. Laminin plays an important role in vivo during the adhesion of epithelial, endothelial, and mesothelial cells 5. XcM BioLogic tissue Matrix is shown to retain both fibronectin and laminins* 1. * the effect of these components on the performance of XcM BioLogic tissue Matrix has not been clinically evaluated. Data on file at DsM. figure 1: Reconstruction of the anterior abdominal wall following a TRAM flap breast reconstruction. case report available upon request from DePuy Synthes companies. figure 1: hematoxylin and eosin stain of the incisional biopsy showing incorporation of the XcM BioLogic tissue Matrix at 4-months post-implantation with tissue ingrowth from all sides (shown at 20x magnification).
8 science that stands out XCM BIOLOGIC Tissue Matrix exhibited less bulging than Strattice TM * 8 7 Average Bulge height (cm) Month explant: external bulge seen after repair with strattice -1 XCM BIOLOGIC Tissue Matrix (n=7) Strattice (n=7) An animal study showed that abdominal wall defects in rabbits repaired with XcM BioLogic tissue Matrix bulged significantly less than defects repaired with strattice after 12 months*. 12-Month explant: external bulge seen after repair with XcM BioLogic tissue Matrix Comparison of XCM BIOLOGIC Tissue Matrix vs. Strattice on key surgical parameters stratice XcM BioLogic tissue Matrix n=90 At DePuy Synthes Companies, we know what really matters to you during surgeries Biomechanical testing shows XcM BioLogic tissue Matrix performs excellently on all of the 3 key surgical parameters tensile strength, suture retention strength, and stretch resistance. (Young s modulus). tensile strength (n/cm) suture retention strength (n) stretch resistance (MPa) * testing of explanted XcM BioLogic tissue Matrix, strattice, and Alloderm grafts from rabbits. Data on file at DsM. Data on file at DsM. Animal studies and biomechanical testing are not necessarily indicative of clinical performance.
9 XCM BIOLOGIC Tissue Matrix, sterile, (hydrated) Dimensions XM s 4 cm x 7 cm, thick XM s 6 cm x 12 cm, thick XM s 6 cm x 16 cm, thick XM s 8 cm x 12 cm, thick XM s 8 cm x 16 cm, thick XM s 8 cm x 20 cm, thick XM s 10 cm x 16 cm, thick XM s 10 cm x 20 cm, thick XM s 12 cm x 20 cm, thick XM s 16 cm x 20 cm, thick XM s 16 cm x 25 cm, thick XM s 20 cm x 20 cm, thick XM s 20 cm x 25 cm, thick XM s 20 cm x 30 cm, thick XM s 20 cm x 40 cm, thick XM tcs tailored coverage 25 cm x 35 cm, thick XM s 25 cm x 40 cm, thick XM s 25 cm x 45 cm, thick XcM BioLogic tissue Matrix is on average 1.5 mm thick ± 0.3 mm. Additional sizes may be available. Please contact your DePuy Synthes CMF sales consultant for details. to order, call DePuy Synthes CMF customer service at (800) hoganson DM, o Doherty em, owens ge, harilal Do, goldman sm, Bowley cm, neville cm, Kronengold rt, Vacanti JP. the retention of extracellular matrix proteins and angiogenic and mitogenic cytokines in a decellularized porcine dermis. Biomaterials. 2010;31: Allison DD, grande-allen KJ. review. hyaluronan: A powerful tissue engineering tool. Tissue Engineering. 2006;12(8): Badylak sf. the extracellular matrix as scaffold for tissue reconstruction. Seminars in Cell & Developmental Biology. 2007;28(25): Brown ra, Phillips JB. cell responses to biomimetic protein scaffolds used in tissue repair and engineering. Int Rev Cytol. 2007;262: tzu J, Marinkovich MP. Bridging structure with function: structural, regulatory and developmental role for laminins. International Journal of Biochemistry & Cell Biology. 2008;40(2): hackett es, harilal D, et al. evaluation of porcine hydrated dermis augmented repair in a fascial defect model. J Biomed Res. 2011;96B(1):
10 Limited Warranty and Disclaimer: DePuy Synthes CMF products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed. WARNING: In the USA, this product has labeling limitations. See package insert for complete information. Rx Only Not all products are currently available in all markets. Distributed by (United States): Synthes USA Products, LLC 1302 Wrights Lane East West Chester, PA Telephone: (610) To order: (800) Fax: (610) Manufactured by: DSM Biomedical 735 Pennsylvania Drive Exton, PA DePuy Synthes CMF, a division of DOI All rights reserved. optrix is a trademark of DSM or its affilitates. Blyscan is a trademark of Biocolor Ltd. DSUS/CMF/0614/ /14 XCM BIOLOGIC Tissue Matrix and Synthes are trademarks of Synthes, Inc. or its affiliates.
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