strength of sciencesynthes.vo.llnwd.net/o16/llnwmb8/us mobile/synthes north...strength of science...

Strength of SCienCe XCM BIOLOGIC® Tissue Matrix

Now with sizes up to 25 cm x 35 cm

Your trusted partner providing a complete portfolio of biologic meshes.

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.

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 fl ap 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.

Soft-tissue reinforcement Defects of thoracic Wall

Plastic and reconstructive Surgeries

hernia repair

Strength of SCienCe

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 fi xation

the device is contraindicated in uses that require rolling, folding, or layering, and which may create a space impermeable to fl uid, cells, and blood vessels. Such uses may result in excessive infl ammation, 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 indica-tions, contraindications, warnings, and/or precautions.

Strength of SCienCe

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 fi bers retain natural strength and

provide pliability to XCM BioLogiC tissue Matrix• highly consistent thickness

Non-cross-linked

• Unique processing maintains the natural 3-D fi brous structure and key eCM components*

• open pore structure allows for cell in-growth and revascularization**

Our partnership with DSM brings you more than 20 years of experience with biologic materials.

* the effect of these components on the performance of XCM BioLogiC tissue Matrix has not been clinically evaluated.

** Data from preclinical animal studies on fi le at DSM. Animal test results may not necessarily be indicative of clinical performance.

Scan the Qr code to see how XCM BioLogiC tissue Matrix open-pore structure allows blood to permeate through it.

Strength of SCienCe

our promise of quality

Quality begins at the source

for DePuy Synthes Companies, quality is the top priority. We have partnered with DSM, which produces XCM BioLogiC tissue Matrix through its innovative optrixtM process. optrixtM maintains natural collagen architecture without cross-linking.

Meticulously tested to ensure patient safety

Shown: Large sizes of XCM BioLogiC tissue Matrix being tested at DSM. each piece is individually tested to ensure only the best product reaches our patients.*

*Data on file at DSM.

optrixtM 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 optrixtM 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.*

Gentle enough to maintain bulk of natural ECM components*†

the optrixtM process retains a high percentage of glycosaminoglycans (gAgs).*

in vivo, gAgs mediate cell communication during tissue repair.†

Strength of SCienCe

*Data on fi le at DSM.† the effect of these components on the performance of XCM BioLogiC tissue Matrix has not been clinically evaluated.

Presence of post-processing glycosaminoglycans (gAgs)*

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): 1996.

90%

80%

70%

60%

50%

40%

30%

20%

0%

XCM BIOLOGIC Surgisis StratticeTissue Matrixn=28 n=4 n=3

% o

f ra

w t

issu

e

1200

1000

800

600

400

200

0

XCM BIOLOGIC Strattice Raw Dermis SurgisisTissue Matrix

DnA concentration of biologic tissue matrices

results of Pico green Assay

ng/mg

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 fi bronectin 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 fi bronectin and laminins.*†1

Strength of SCienCe

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 magnifi cation).

* the effect of these components on the performance of XCM BioLogiC tissue Matrix has not been clinically evaluated.

†Data on fi le at DSM.

figure 1: Reconstruction of the anterior abdominal wall following a TRAM fl ap breast reconstruction. Case report available upon request from DePuy Synthes Companies.

XCM BIOLOGIC Tissue Matrix exhibited less bulging than StratticeTM*†

Strength of SCienCe

12-Month explant: external bulge seen after repair with Strattice

12-Month explant: external bulge seen after repair with XCM BioLogiC tissue Matrix

* testing of explanted XCM BioLogiC tissue Matrix, Strattice, and Alloderm grafts from rabbits. Data on fi le at DSM.

† Data on fi le at DSM. Animal studies and biomechanical testing are not necessarily indicative of clinical performance.

An animal study showed that abdominal wall defects in rabbits repaired with XCM BioLogiC tissue Matrix bulged signifi cantly less than defects repaired with Strattice after 12 months.*†

Comparison of XCM BIOLOGIC Tissue Matrix vs. Strattice on key surgical parameters†

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).†

Science that stands out

8

7

6

5

4

3

2

1

0

-1XCM BIOLOGIC Tissue Matrix (n=7) Strattice (n=7)

Ave

rag

e Bu

lge

hei

ght

(cm

)

140.9

177.5

44.7 45.836.65

62.52

tensile Strength (n/cm) Suture retention Strength (n) Stretch resistance (MPa)

� Stratice� XCM BioLogiC tissue Matrixn=90

Strength of SCienCe

Leading the way with the Strength of Science

XCM BioLogiC tissue Matrix is shown to retain, in vitro, higher levels of vascular endothelial growth factor (Vegf) and transforming growth factor-β (tgf-β) compared to competitors’ decellularized dermis materials.*

* in vitro test results are not necessarily indicative of clinical performance. the effects of these components on the performance of XCM BioLogiC tissue Matrix has not been clinically evaluated.

“in appropriately selected patients, the product performs in a consistent and reliable manner. it has allowed me to repair complex defects in a variety of clinical conditions. it meets all my expectations of a biologic. there is no comparison for customer service - Synthes leads the way. every single time, the customer service from the front line representatives is outstanding.”*

Michael A. Baumholtz, MD, MS, fACSPlastic Surgeon, Private PracticeSan Antonio Cosmetic SurgerySan Antonio, tX

“XCM is remarkably strong yet it has superb handling qualities. it has enough strength to handle a variety of suture materials. it is rela-tively easy to pass suture through it without bending needle or tearing the graft. the po-rosity is very good. i have used XCM for a long time and haven’t seen patients who have failed to incorporate their graft. the sales support which Synthes makes available is ex-traordinary. no stone is left unturned to get the physician the information they need to make a proper decision for their patient.”*

David halpern, MD, fACSAssociate Clinical Professor of Plastic Surgery University of South florida

“When used as an interpositional material, we always had recurrences of ventral hernias repaired with human biologics. i have now entirely transitioned to porcine products for abdominal wall surgery. A porcine biologic, especially XCM, is much stronger and durable. i have not had any problems with XCM.”*

eduardo D. rodriguez, MD, DDSProfessor of SurgeryUniversity of Maryland School of Medicine Program in traumaChief, Plastic, reconstructive and Maxillofacial Surgeryr Adams Cowley Shock trauma Center

Strength of SCienCe

“i fi nd the strength and durability of XCM to be excellent. in the patients in whom i have used XCM for chest wall reconstruction, it has held up well as evidenced by the lack of chest wall hernia and lack of scapula entrapment seen on follow-up visits. XCM is easy to use, right out of the package without any prep time. it holds sutures well and has excellent pliability.”*

Jess D. Schwartz, MD, fACS, fCCPAssistant Professor of Surgery Division of Cardiothoracic SurgeryUniversity of new Mexico health Science Center

* results from individual experiences are not necessarily predictive of results for other practitioners. results may vary.

Strength of Science to provide outstanding care to your patients

© DePuy Synthes CMf, a division of Doi 2013. All rights reserved. optrix is a trademark of DSM. Blyscan is a trademark of Biocolor Ltd. XCM BioLogiC tissue Matrix and Synthes are trademarks of Synthes, inc. or its affiliates. Printed in U.S.A. 1/14 J11959-B

XCM BIOLOGIC Tissue Matrix, sterile, (hydrated) Dimensions

XM106.0407S 4 cm x 7 cm, thick














XM106.2535tCS tAiLoreD CoVerAge™

25 cm x 35 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 Sales Consultant for details. to order, call DePuy Synthes Customer Service at (800) 668-1119.

DSM Biomedical735 Pennsylvania Driveexton, PA 19341

Manufactured by

1. 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;31:6730-7.

2. Allison DD, grande-Allen KJ. review. hyaluronan: A powerful tissue engineering tool. Tissue Engineering. 2006;12(8):2131-40.

3. Badylak Sf. the extracellular matrix as scaffold for tissue reconstruction. Seminars in Cell & Developmental Biology. 2007;28(25):3587-93.

4. Brown rA, Phillips JB. Cell responses to biomimetic protein scaffolds used in tissue repair and engineering. Int Rev Cytol. 2007;262:75-150

5. tzu J, Marinkovich MP. Bridging structure with function: structural, regulatory and developmental role for laminins. International Journal of Biochemistry & Cell Biology. 2008;40(2):199-214.

Strength of SCienCe

DePuy Synthes CMF1302 Wrights Lane eastWest Chester, PA 19380telephone: (610) 719-5000to order: (800) 523-0322

www.depuysynthes.com

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 fi tness, are hereby disclaimed.

WARNING: In the USA, this product has labeling limitations. See package insert for complete information.

CAUTION: USA Law restricts these devices to sale by or on the order of a physician.

not all products are currently available in all markets.

strength of sciencesynthes.vo.llnwd.net/o16/llnwmb8/us mobile/synthes north...strength of science...

Documents