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XCM Biologic Tissue Matrix. Regenerative matrix for reinforcement and repair of soft tissue. Hydrated, ready-to-use Allows for cellular infiltration Strength without crosslinking
XCM Biologic Tissue Matrix.Regenerative matrix for reinforcementand repair of soft tissue.
Hydrated,ready-to-use
Allows for cellularinfiltration
Strength withoutcrosslinking
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 struc-tures of 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 tobe 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 hydrat-ing or rinsing is required. Once the tissue matrix is implanted,it provides a structure that can be infiltrated by the body’scells.
SEM cross section of XCM Biologic Tissue Matrix (500� magnification)
2 Synthes XCM Biologic Tissue Matrix
Features
XCM Biologic Tissue Matrix provides reinforcement and repair of soft tissueduring healing.
– Hydrated and ready-to-useout 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 – Consistent thickness– No orientation required– Terminally sterilized
Hyaluronan
GlycoproteinElastinCollagen
Synthes 3
Clinical applicationsClinical applications include, but arenot limited to the following:– Hernia repair– Defects of the thoracic wall– Suture line reinforcement– Muscle flap reinforcement– Plastic and reconstructive procedures
– Breast reconstruction– Abdominal wall reconstruction– Orofacial 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 (200� magnification)+
+ Immunohistochemical stains courtesy of VacantiLaboratory for Tissue Engineering and OrganFabrication, Massachusetts General Hospital
Proteoglycan Molecule
4 Synthes XCM Biologic Tissue Matrix
Indications and Contraindications
IndicationsXCM Biologic Tissue Matrix is indicated for use in generalsurgical procedures for the reinforcement and repair of softtissue where weakness exists including, but not limited to;defects of the thoracic wall, suture line reinforcement, andmuscle flap reinforcement; hernia repair; soft tissue recon-structive procedures including but not limited to plastic andreconstructive surgical applications such as breast reconstruc-tion, abdominal wall reconstruction, and orofacial recon-structive procedures; and for reinforcement of the soft tis-sues, which are repaired by suture or suture anchors. XCMBiologic Tissue Matrix is intended for one time use.
ContraindicationsThis device is derived from a porcine source and should notbe used for patients with known sensitivity to porcine mate-rial. The device is contraindicated for patients known to beundergoing desensitization injections to meat products, asthese injections can contain porcine collagen.
Abdominal wall XCM Biologic Tissue Matrix placement options for abdominalwall reconstruction and hernia repair.
A
B
C
D
E
A OnlayB InlayC SublayD UnderlayE Intraperitoneal
Synthes 5
Device Properties
Biomechanical TestingXCM Biologic Tissue Matrix has been subjected to biome-chanical testing 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 normal-ized to the width of the dogbone. XCM Biologic Tissue Ma-trix demonstrates an average tensile strength of 130 N/cm,greater than leading products made from PTFE, heavyweightmacroporous polypropylene, and midweight macroporousprolene/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 Tis-sue Matrix demonstrates a suture retention strength of 54 N,far in excess of PTFE and midweight macroporous prolene/cellulose/PDS.
* Data on file at Kensey Nash Corporation
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 strengthN
XCM BiologicMatrix
Composite Prolene/PDS
PTFE
6 Synthes XCM Biologic Tissue Matrix
Kensey Nash Corporation’s OptrixCleansing 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 naturalarchitecture in XCM Biologic Tissue Matrix.
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.* Data on file at Kensey Nash Corporation
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 re-moves antigenic components from biologic materials whilemaintaining the native collagen structure and key extracellu-lar matrix molecules used in tissue reconstruction.2 The resultis a strong, acellular biologic graft that facilitates soft tissuehealing.*
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 revascularizationand tissue regeneration
1200
1000
800
600
400
200
0
DNA Measured by Pico Green
ng D
NA
/mg
XCM BiologicMatrix
RawDermis
PorcineSiS
Device
HumanDermisDevice
Synthes 7
Histological Profiles
Immunohistochemical evaluation of XCM Biologic Tissue Ma-trix 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 beenconfirmed 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 Ma-trix is 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
Immunohistochemical staining in raw dermis (top) and XCM Biologic Tissue Matrix(bottom). Purple staining indicates cells and red staining indicates the presence ofhyaluronic acid.+
* Data on file at Kensey Nash Corporation+ Immunohistochemical stains courtesy of Vacanti Laboratory for Tissue
Engineering and Organ Fabrication, Massachusetts General Hospital
8 Synthes XCM Biologic Tissue Matrix
Immunohistochemistry was used to confirm the presenceof glycoproteins such as fibronectin and laminin.+2 Fi-bronectin plays a vital role in cell adhesion, cell differentia-tion, and is highly involved in tissue reconstruction.8 Lamininis an important molecule for the adhesion of epithelial, en-dothelial, and mesothelial cells, and a key factor in tissuemaintenance.9
Alcian blue staining and spectrophotometric analysis byBlyscan assay confirmed the presence of sulfated gly-cosaminoglycans (GAG). Immunohistochemistry confirmedthe presence of non-sulfated GAGs (hyaluronic acid).+*GAGs are highly charged molecules that are important forcell-cell signaling and cell-matrix interaction. GAGs sequesterwater for structural support and play important roles in theregulation of many tissue 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
A 4 �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).
* Data on file at Kensey Nash Corporation
Synthes 9
Sheep Fascia Repair Study
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
10 Synthes XCM Biologic Tissue Matrix
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.
Biomechanical testing of surgical sites after healing. XCM Biologic Tissue Matrix maintains strengths greaterthan native tissue throughout the healing process.
Sheep Fascia Repair Study
* Data on file at Kensey Nash Corporation
Synthes 11
Product Information
XCM Biologic Tissue Matrix, sterile, hydrated Dimensions
XM106.0204S 2 cm � 4 cm, thick
XM106.0407S 4 cm � 7 cm, thick
XM106.0416S 4 cm � 16 cm, thick
XM106.0516S 5 cm � 16 cm, thick
XM106.0612S 6 cm � 12 cm, thick
XM106.0616S 6 cm � 16 cm, thick
XM106.0620S 6 cm � 20 cm, thick
XM106.0812S 8 cm � 12 cm, thick
XM106.0816S 8 cm � 16 cm, thick
XM106.0820S 8 cm � 20 cm, thick
XM106.1016S 10 cm � 16 cm, thick
XM106.1020S 10 cm � 20 cm, thick
XM106.1220S 12 cm � 20 cm, thick
XM106.1620S 16 cm � 20 cm, thick
XM106.1625S 16 cm � 25 cm, thick
XM106.2020S 20 cm � 20 cm, thick
XM106.2025S 20 cm � 25 cm, thick
XM106.2030S 20 cm � 30 cm, thick
Additional sizes may be available. Please contact your Synthes Sales Consultant for details.
Note: For additional information, please refer to package insert.
12 Synthes XCM Biologic Tissue Matrix
References
1. U. Klinge, et. al. “Modified mesh for hernia repair thatis 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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