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XCM Biologic Tissue Matrix.Regenerative matrix for reinforcementand repair of soft tissue.

Hydrated, ready-to-use

Allows for cellular infiltration

Strength withoutcrosslinking

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Synthes 1

XCM Biologic Tissue Matrix

XCM Biologic tissue matrix is a sterile non-cross-linked 3-D matrix derived from porcine dermis. Dermis is composedof cells and extracellular matrix (ECM), a combination of proteins, proteoglycans, glycosaminoglycans, and other biological materials produced by cells that form the structuresof all the tissues in the body.

XCM Biologic tissue matrix is manufactured by Kensey NashCorporation and available through Synthes CMF.

XCM Biologic tissue matrix undergoes Kensey Nash’s proprietary Optrix process, which has been developed to be strong enough to disinfect the tissue, inactivate viruses,and remove the cells, yet gentle enough to maintain the bulkof the natural ECM components and minimize damage tothe tissue architecture.

The result is a strong biologic implant with the propertiesneeded to facilitate soft tissue healing. XCM Biologic tissuematrix is ready-to-use, right out of the package. No hydratingor rinsing is required. Once the tissue matrix is implanted, itprovides a structure that can be infiltrated by the body’s cells.

SEM cross section of XCM Biologic Tissue Matrix (500x magnification)

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2 Synthes XCM Biologic Tissue Matrix

Features

XCM Biologic tissue matrix provides reinforcement and repair of soft tissueduring healing.

– Hydrated and ready-to-use out of the package

– Structurally allows for cellular infiltration

– Strength without crosslinking – Can be stored at room temperature– No risk of human disease transmission– No prestretching required– Large sizes available – Highly consistent thickness– No orientation required– Terminally sterilized

Hyaluronan

GlycoproteinElastinCollagen

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Clinical applications

Clinical applications include, but are not limited to the following:– Hernia repair– Defects of the thoracic wall– Suture line reinforcement– Muscle flap reinforcement– Plastic and reconstructive procedures

Fibroblasts growing into XCM Biologic tissue matrixafter 7 days in culture. Immunohistochemical stainingof intracellular actin filaments (red) and nuclei (blue)show excellent attachment (200x magnification)†

† Immunohistochemical stains courtesy of VacantiLaboratory for Tissue Engineering and OrganFabrication, Massachusetts General Hospital

Proteoglycan Molecule

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Indications and Contraindications

Indications

XCM Biologic tissue matrix is indicated for use in general surgical procedures for the reinforcement and repair of softtissue where weakness exists, including, but not limited to;defects of the thoracic wall, suture line reinforcement, muscleflap reinforcement, hernia repair, soft tissue reconstructiveprocedures including plastic and reconstructive surgical applications, and for reinforcement of soft tissues which arerepaired by suture or suture anchors.

XCM Biologic tissue matrix is indicated for one time use.

Contraindications

This device is derived from a porcine source and should notbe 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 whomsoft-tissue implants are contraindicated, including:– Blood supply limitations– Pathologic soft-tissue conditions that would prevent

secure fixation

The device is contraindicated in uses that require rolling, folding, or layering, and which may create a space impermeableto 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 sutureretention strength has not resulted in any reported problemsin similar products, and is appropriate when indicated.

The device is contraindicated for patients with severe allergiesmanifested by a history of anaphylaxis, history of multiple severe allergies, or known allergies against porcine collagen.

For a full list of warnings and precautions, please refer to thepackage insert.

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Synthes 5

Device Properties

Biomechanical Testing

XCM Biologic tissue matrix has been subjected to biomechanicaltesting to characterize its physical properties.

Tensile testing was conducted according to internationallyrecognized standard procedures, which subjects a dogbone-shaped sample to tensile forces at 50 mm per minute andmeasures the maximum tensile force.* All forces are normalizedto the width of the dogbone. XCM Biologic tissue matrixdemonstrates an average tensile strength of 130 N/cm,greater than leading products made from PTFE, heavyweightmacroporous polypropylene, and midweight macroporous prolene/cellulose /PDS, and well in excess of normal human fascia.1

Testing was conducted to determine the ability of the tissuematrix to withstand suture pull-out forces. A #2 suture wasplaced 2 mm from the edge of the device. XCM Biologic tissue matrix demonstrates a suture retention strength of 54 N, far in excess of PTFE and midweight macroporous prolene/cellulose /PDS.

140

120

100

80

60

40

20

0

Tensile strength

Native Fascia strength=16 N/cm

N/c

m

XCM BiologicMatrix

Composite Prolene/PDS

P-propylene PTFE

60

50

40

30

20

10

0

Suture pull-out strength

N

XCM BiologicMatrix

Composite Prolene/PDS

PTFE

* Data on file at Kensey Nash Corporation

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Kensey Nash Corporation’s Optrix Cleansing Process

Hematoxylin and eosin image of XCM Biologic tissue matrix (bottom). Note cells(dark blue) in raw material (top), and no cells and preservation of natural architecturein XCM Biologic tissue matrix.

DNA Measured by Pico Green

ng D

NA

/mg

XCM BiologicMatrix

RawDermis

PorcineSiS

Device

HumanDermisDevice

1200

1000

800

600

400

200

0

Results of Pico Green testing measuring the amount of DNA in a test sample. XCM Biologic tissue matrix is reduced to background levels of residual DNA.


Kensey Nash is a regenerative medicine company with morethan 20 years of experience in processing biologic materials.Kensey Nash has drawn from this experience to develop theOptrix cleansing process. This tissue cleansing process removesantigenic components from biologic materials while maintainingthe native collagen structure and key extracellular matrixmolecules used in tissue reconstruction.2 The result is a strong,acellular biologic graft that facilitates soft tissue healing.*

Key features of the Optrix process used in the manufacturingof XCM Biologic tissue matrix include:*

– Removal of cells and DNA– Inactivation and clearance of viruses– Maintenance of intact collagen structure for excellent

strength and durability without crosslinking– Preservation of natural fibrous architecture that provides

a scaffold for cell in-growth and proliferation– Retention of beneficial extracellular matrix molecules

resulting in a scaffold that allows revascularization and tissue regeneration

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Histological Profiles

Immunohistochemical evaluation of XCM Biologic tissue matrix confirms that the major components of the extracellularmatrix are preserved after processing.†

XCM Biologic tissue matrix was evaluated for proteins suchas collagen. Collagen is the most abundant structural proteinfound in mammals and plays an important role in tissue organization and biomechanical support.3 Utilizing immuno-histochemical assays, various collagen types have been confirmed to be present in XCM Biologic tissue matrix including types 1, 3, 4 and 7 collagen.*† Types 1 and 3 collagens are produced by fibroblasts and are the essentialstructural elements of most soft tissues.4 Types 4 and 7 collagens provide attachment sites for epithelial, endothelial,and mesothelial cells.2 Maintenance of the natural collagenarchitecture as demonstrated in the XCM Biologic tissue matrixis an important property of tissue regeneration scaffolds.5

The presence of elastin was confirmed through Van Giesonstaining.2 Elastin is another important structural protein required for proper biomechanical function of various softtissues.6 As elastin is degraded, its fragments become matrikines which are chemotactic for numerous cell types.7

* Data on file at Kensey Nash Corporation† Immunohistochemical stains courtesy of Vacanti Laboratory for Tissue

Engineering and Organ Fabrication, Massachusetts General Hospital

Immunohistochemical staining in raw dermis (top) and XCM Biologic tissue matrix(bottom). Purple staining indicates cells and red staining indicates the presence ofhyaluronic acid.†

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Immunohistochemistry was used to confirm the presence of glycoproteins such as fibronectin and laminin.†2 Fibronectinplays a vital role in cell adhesion, cell differentiation, and is highlyinvolved in tissue reconstruction.8 Laminin is an importantmolecule for the adhesion of epithelial, endothelial, andmesothelial cells, and a key factor in tissue maintenance.9

Alcian blue staining and spectrophotometric analysis by Blyscanassay confirmed the presence of sulfated glycosaminoglycans(GAG). Immunohistochemistry confirmed the presence ofnon-sulfated GAGs (hyaluronic acid).†* GAGs are highlycharged molecules that are important for cell-cell signaling andcell-matrix interaction. GAGs sequester water for structuralsupport and play important roles in the regulation of manytissue functions, such as tissue repair.10

Immunohistochemical staining in raw dermis (top) and XCM Biologic tissue matrix(bottom). Blue staining indicates cells and green staining indicates fibronectin.†

* Data on file at Kensey Nash Corporation† Immunohistochemical stains courtesy of Vacanti Laboratory for Tissue

Engineering and Organ Fabrication, Massachusetts General Hospital

Histological Profiles

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Synthes 9

Sheep Fascia Repair Study

A 4 x 4 cm window defect was createdin sheep fascia lata and abdominal wallfascia and repaired with XCM Biologictissue matrix. After 6 and 12 weeks,the implant sites were harvested andsubjected to mechanical testing andhistological analysis.

The implant sites appeared to be wellintegrated with the surrounding tissueat both 6 and 12 weeks. There was noevidence of bulging of the underlyingmuscle. Based on tactile feel, the repaired tissue felt identical to the native host tissue.*

The tissue matrix was fixed upon explantation, sectioned, and stained by hematoxylin and eosin to assess cellpenetration and tissue repair. Histologyshowed excellent incorporation withthe surrounding tissues and cell infiltration.*

Sheep fascia window defect at the time of surgery (left) and repaired with XCM Biologic tissue matrix (right).

Surgical site after 6 weeks (left) and 12 weeks (right).

High Res art to come


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Biomechanical testing was conductedby cutting dogbone-shaped samplesfrom the repaired tissue at the centerof the implant. The test samples weresubjected to tensile testing at 24 mmper minute. The biomechanical testingproved that the repair sites implantedwith XCM Biologic tissue matrix main-tained strengths greater than normalfascia throughout the healing process.*

Histology at 6 weeks (left) and 12 weeks (right). Note cell infiltration at 6 weeks, and repair tissue at 12 weeks.

150

120

90

60

30

0

Surgical Site Strength over Time

Tens

ile S

tren

gth

(N/c

m)

Initial 6 week 12 week

XCM Biologic Tissue MatrixHealing FasciaBaseline Fascia

Biomechanical testing of surgical sites after healing. XCM Biologic tissue matrix maintains strengths greater thannative tissue throughout the healing process.

Sheep Fascia Repair Study


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Synthes 11

Product Information

XCM Biologic Tissue Matrix, sterile, (hydrated)Dimensions

XM106.0204S 2 cm x 4 cm, thick


















Additional sizes may be available. Please contact your Synthes Sales Consultant for details. To order, call Synthes Customer Service at (800) 668-1119.

Note: For additional information, please refer to package insert.

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References

1. U. Klinge, et. al. “Modified mesh for hernia repair that is adapted to the physiology of the abdominal wall.” European Journal of Surgery. 1998 Dec; 164(12):951–960.

2. S.F. Badylak. “The extracellular matrix as a scaffold fortissue reconstruction.” Seminars in Cell & DevelopmentalBiology. 2002 Oct; 13(5): 377–383.

3. W. Friess. “Collagen—biomaterial for drug delivery.” Eur J Pharm Biopharm. 1998 Mar; 45(2): 113-136.

4. M.J. Beckman, et. al. “Collagen.” Encyclopedia of Biomaterials and Biomedical Engineering, 2004: 324–334.

5. M. Sandor, et. al. “Host response to implanted porcine-derived biologic materials in a primate model of abdominalwall repair.” Tissue Engineering: Part A 14(12), 2008:2021–2031.

6. L. Debelle, A.M. Tamburro, “Elastin: molecular descriptionand function.” International Journal of Biochemistry &Cell Biology 31(2), 1999: 261–272.

7. L. Duca, et. al. “Elastin as a matrikine.” Critical Reviewsin Oncology/Hematology. 2004 Mar; 49(3): 235–244.

8. R.A. Brown, J.B. Phillips. “Cell Responses to BiomimeticProtein Scaffolds Used in Tissue Repair and Engineering.”International Review of Cytology 262, 2007: 75–150.

9. J. Tzu, M.P. Marinkovich. “Bridging structure with function:structural, regulatory, and developmental role of laminins.”International Journal of Biochemistry & Cell Biology40(2), 2008, 199–214.

10. D.D. Allison, K.J. Grande-Allen, “Review. Hyaluronan: a powerful tissue engineering tool.” Tissue Engineering.2006 Aug; 12(8): 2131–2140.

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Optrix is a trademark of Kensey Nash Corporation. Blyscan is a trademark of Biocolor Ltd. © 2010 Synthes, Inc. or its affiliates. All rights reserved. XCM Biologic and Synthes are trademarks of Synthes, Inc. or its affiliates. Printed in U.S.A. 4/11 J9652-D

Distributed bySynthes CMF1302 Wrights Lane EastWest Chester, PA 19380Telephone: (610) 719-5000To order: (800) 523-0322Fax: (610) 251-9056 www.synthes.com

Kensey Nash Corporation735 Pennsylvania DriveExton, PA 19341

Manufactured by

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