Regenerative Collagen Matrix XenMatrix Surgical …...XenMatrix Surgical Graft Regenerative Collagen...

XenMatrix™ Surgical GraftRegenerative Collagen Matrix

Structure. Strength. Performance

XenMatrix™ Surgical GraftRegenerative Collagen Matrix

Structure. Strength. Performance.

SOFT TISSUE REPAIRRight Procedure. Right Product. Right Outcome.

1 Preclinical clinical data on file, results may not correlate to clinical performance.2 Deeken CR, Eliason B, Pichert M, Grant S, Frisella M, Matthews B. “Differentiation of Biologic Scaffold Materials Through Physicomechanical, Thermal, and Enzymatic

Degradation Techniques” Ann Surg 2012 Mar;255(3):595-604.

3 Literature Search: Clinical publications with XenMatrix Surgical Graft, published in last 5 years through 8/13, performed on Google Scholar and PubMed. Inclusion criteria, all preclinical and clinical studies published in peer-reviewed journals.

XenMatrix™ Surgical Graft

XenMatrix™ Grafts are created using the patented AquaPure™ Process which effectively removes cells while maintaining the

structure and strength of the graft. The resulting open collagen scaffold allows early cellular infiltration and revascularization

without a significant loss of strength during the early healing period.1

Demonstrated Performance

Structure• Acellular non-cross-linked

porcine collagen scaffold

• Open collagen structure allows early cellular infiltration and revascularization1

Strength• Demonstrated mechanical

strength2

• Maintains strength throughout the initial healing period1

• Peer-reviewed clinical data

• 31 articles published in peer-reviewed journals since 20093

Performance

Unique XENMATRIX™ Surgical Graft open collagen scaffold.

Representative Illustration

Building Confidence with Successful Outcomes in Hernia Repair

Demonstrated Mechanical StrengthMechanical test data confirmed the performance of the XenMatrix™ Surgical Graft was above the threshold set by Deeken et. al., for absorbable and nonabsorbable barrier composite meshes.2,3,4

Peer-Reviewed Data Demonstrated4

Mesh Type Thickness (mm) Suture Retention Strength (N) Tear Resistance (N) Ball Burst Strength (N/cm)

XenMatrix™† 1.95 ± 0.012 99.74 ± 7.7 24.5 ± 1.9 377 ± 41.34

Strattice™ Firm† 1.76 ± 0.012 63.76 ± 4.8 27.54 ± 1.9 270.5 ± 48.91

SurgiMend™ 0.84 ± 0.024 87.85 ± 4.9 27.86 ± 1.0 432.4 ± 14.19

Veritas™ 0.80 ± 0.017 23.92 ± 2.4 15.06 ± 2.2 128.6 ± 8.52

Threshold values suggested as suitable properties for hernia repair applications2,3 >20N >20N

1 Davol Internal Reports. Bench data may not correlate to clinical use. N=minimum of 10 samples.2 Deeken CR, Abdo MS, Frisella MM, Matthews BD. “Physicomechanical Evaluation of Absorbable and Nonabsorbable Barrier Composite Meshes for Laparascopic Ventral Hernia Repair.” Surg

Endosc 2011 May 25(5): 1541-52.3 Deeken CR, Abdo MS, Frisella MM, Matthews BD. “Physicomechanical Evaluation of Polypropylene, Polyester, and Polytetrafluoroethylene Meshes for Inguinal Hernia Repair.” J Am Coll Surg

2011; 212:68-79.4 Deeken CR, Eliason B, Pichert M, Grant S, Frisella M, Matthews B. “Differentiation of Biologic Scaffold Materials Through Physicomechanical, Thermal, and Enzymatic Degradation Techniques”

Ann Surg 2012 Mar;255(3):595-604. 5 Badylak, S.F., Freytes, D.O., and Gilbert, T.W. “Extracellular matrix as a biological scaffold material: Structure and function.” Acta Biomaterialia. 5(2009) 1-13.6 Murphy CM, Haugh MG, O'Brien FJ “The effect of mean pore size on cell attachment, proliferation and migration in collagen-glycosaminoglycan scaffolds for bone tissue engineering.”

Biomaterials. 2010 Jan;31(3):461-6.† Non-cross-linked porcine dermis.

Demonstrated Porous StructureXenMatrix™ Surgical Graft has almost 3x more open space than Strattice™ Firm. 1

XENMATRIX™ Surgical Graft,H&E Stain 40x, 47% open space

Strattice™ Firm,H&E Stain 40x, 16% open space

Repairing the abdominal wall with a strong, open collagen scaffold allows early remodeling.

Demonstrated Process Impacts Structure and Strength1,5,6

AquaPure™ Process

The patented AquaPure™ Process effectively transforms raw dermis into an extracellular matrix while maintaining the structure and strength

of the graft. XenMatrix™ Surgical Grafts are the only porcine dermis product for hernia repair that are created using this patented process.

TISSUE HARVESTING

TISSUE CLEANSING

CELLULAR MATERIAL REMOVAL

VIRAL INACTIVATION

E-BEAM STERILIZATION


Demonstrated Preclinical Performance Study Type

Preclinical Study – 24 male Sprague-Dawley rats* (400-450g)

Objective

Assess the strength over time of the XenMatrix™ Surgical Graft

Study Design

Central, full thickness 0.5 cm incisional surgical defect was created in the ventral abdominal wall. A 38 mm circular

XenMatrix™ Surgical Graft was fixated directly over the defect with five interrupted 5-0 polypropylene sutures.

Ball burst testing was conducted at T=0, 2 weeks, 8 weeks and 12 weeks.

Results

Confirmed remodeling: XenMatrix™ Grafts 2 weeks post-implantation in a preclinical model:*

• Early cellular infiltration

• New collagen deposition

• Early blood vessel formation

H&E, 10x

H&E, 60x

* Preclinical clinical data on file, results may not correlate to clinical performance.

New Collagen

Blood Vessels

Demonstrated RemodelingPreclinical testing confirmed early tissue ingrowth, vascular integration, and incorporation into the ventral abdominal wall.*

Representative necropsy photographs of XenMatrix™ Surgical Grafts at 2, 8 and 12 weeks post-implantation demonstrated tissue ingrowth, vascular integration and incorporation into the ventral abdominal wall.7

Demonstrated Strength Over TimeIn preclinical testing the XenMatrix™ Surgical Graft maintains a significant amount of strength during the critical early

healing period suggesting it may be well suited for the demands of abdominal wall repair.7

7 Preclinical clinical data on file, results may not correlate to clinical performance.

600

500

400

700

200

100

300

0

0 2 8 12 Time (weeks)

Bal

l Bur

st F

orce

(N

)


Strattice™ Reconstructive Tissue Matrix

* P<0.05

Representative histology photographs of XenMatrix™ Surgical Graft at 2, 8 and 12 weeks post-implantation demonstrated early tissue remodeling.7

Building Confidence with Preclinical Data

20x 20x 10x


Hernia. 2013 Feb.

Abdominal Wall Reconstruction Using a Non-Cross-Linked Porcine Dermal Scaffold: A Follow-Up Study.9†

Diaz-Siso JR, Bueno EM, Pomahac B. Division of Plastic Surgery, Brigham and Women’s Hospital, Harvard Medical School, MA 02115, USA.

Key Points:

“ Our findings suggest that XenMatrix™ is an effective adjunct in the recon-struction of complex abdominal wall defects, resulting in satisfactory outcomes at an average follow-up time of 40.1 months and yielding a low rate of surgical complications.”

Hernia. 2013 Feb. [Epub ahead of print].

Onlay ventral hernia repairs using porcine non-cross-linked dermal biologic mesh.11†

Alicuben ET, DeMeester SR. Department of Surgery, Keck School of Medicine, The University of Southern California, 1510 San Pablo St, Suite 514, Los Angeles, CA 90033, USA.

Key Points:

“ Porcine non-cross-linked biologic mesh (XenMatrix™) overlay has excellent short-term results. No patients required mesh removal, and there have been no recurrent hernias in patients with primary fascial closure. Biologic bridging is not effective for long-term abdominal wall reconstruction.”

Am Surg. 2011 Feb;77(2):144-50.

Repair of High-Risk Incisional Hernias and Traumatic Abdominal Wall Defects with Porcine Mesh.10† Byrnes MC, Irwin E, Carlson D, Campeau A, Gipson JC,

Beal A, Croston* JK.

Department of Trauma, North Memorial Medical Center, Robbinsdale, Minnesota 55422, USA.

Key Points:

“Complex ventral hernias can be repaired with a low recurrence rate. Our technique in combination with the XenMatrix™ biologic mesh provides for a durable repair.”

Key Points:

“ Because [the XenMatrix™ graft] is non-cross-linked, it facilitates tissue ingrowth and remodeling, while minimizing the risks of encapsulation and fibrotic tissue formation commonly associated with synthetics and biosynthetics.”

Am J Surg. 2010 Jan;199(1):22-7.

Use of a Non-Cross-Linked Porcine Dermal Scaffold in Abdominal Wall Reconstruction.8

Pomahac B, Aflaki P. Division of Plastic Surgery, Brigham and Women’s Hospital, Harvard Medical School, MA 02115, USA.

Published Clinical Performance

8 Pomahac B, Aflaki P “Use of a non-cross-linked porcine dermal scaffold in abdominal wall reconstruction.” Am J Surg. 2010 Jan;199(1):22-7. 9 Diaz-Siso JR, Bueno EM, Pomahac B. Abdominal Wall Reconstruction Using a Non-Cross-Linked Porcine Dermal Scaffold: A Follow-Up Study. Hernia. 2013 Feb.10 Byrnes MC, Irwin E, Carlson D, Campeau A, Gipson JC, Beal A, Croston JK. “Repair of high-risk incisional hernias and traumatic abdominal wall defects with porcine mesh.” Am Surg. 2011 Feb;77(2):144-50.11 Alicuben ET, DeMeester SR. “Onlay ventral hernia repairs using porcine non-cross-linked dermal biologic mesh.” Hernia. 2013 Feb. [Epub ahead of print].† Davol Inc. provided financial support in the form of a research fellow salary. † † Data on file at Davol but not published in this study.* Dr. Croston is a paid consultant for Davol Inc. Brennen Medical LLC, the former manufacturer of the XenMatrix™ Surgical Graft provided support for this study.

Building Confidence with Published Clinical Data

Pomahac XenMatrix™ Surgical Graft 8

Diaz-Siso/Pomahac XenMatrix™ Surgical Graft 9†

Byrnes/Croston* XenMatrix™ Surgical Graft 10

Alicuben/DeMeesterXenMatrix™ Surgical Graft 11

Published in peer- reviewed journal

Yes Yes Yes Yes

Population 16 patients 40 patients 57 patients 22 patients

Types of cases

cleanclean contaminatedcontaminateddirty



cleanclean contaminatedcontaminated dirty

BMI Average BMI 27.5 Average BMI 29 Average BMI 31.7; 8 patients >40 Average BMI 26

Biologic graft placement

Underlay Underlay Underlay Onlay

Average defect sizes

Average area repaired: 440 cm2 Average area repaired: 435 cm2 Average area repaired: 180 cm2 Average area repaired: 532 cm2

Comorbidities Heart disease 31.3% Diabetes 31.3% Hypertension 50% Renal insufficiency 12.5% Immunosuppression/steroid

use 12.5%

Heart disease 22.5% Diabetes 17.5% Hypertension 47.5% Renal insufficiency 7.5% Immunosuppression/steroid use 10% Obesity 40%COPD 12.5%

Smokers 29%Insulin dependent diabetes 27%

Not reported

Component separation & bridging

CST 44%; bridging 19% CST 45%; bridging 20% CST 36%; bridging 16% CST: 73%; bridging 4.5%

Average follow-up 16.5 months 40.1 months 30.6 months 7 months (median)

ASA score range 1-4 1-4 1-4†† Not reported

Results RESULTS: 1 (7%) recurrence1 (7%) infection1 (7%) superficial wound

dehiscence3 (21%) seromas

(Note: Recurrence was 12 months post-op due to disattachment along right costal margin; repaired by reattaching. Graft noted to be completely revascularized and incorporated into host tissue)

RESULTS: 3 (7.9%) recurrence2 (5.2%) infection8 (21%) seromas 1 (2.6%) recurrent fistula2 (5.2%) early deaths unrelated

to graft

RESULTS: 4 (7.2%) recurrences = early

technical failures 3 VAC drying graft1 disrupted suture2 (3.5%) early deaths

unrelated to graft

0 (0%) Mesh infections 0 (0%) Fistula 0 (0%) Symptomatic seromas

RESULTS: 1 (4.5%) recurrence, patient’s

defect was bridged 2 (9%) wound infections,

both treated successfully with VAC Therapy

6 (27%) seromas

Documented Clinical Results

8 Pomahac B, Aflaki P “Use of a non-cross-linked porcine dermal scaffold in abdominal wall reconstruction.” Am J Surg. 2010 Jan;199(1):22-7. 9 Diaz-Siso JR, Bueno EM, Pomahac B. Abdominal Wall Reconstruction Using a Non-Cross-Linked Porcine Dermal Scaffold: A Follow-Up Study. Hernia. 2013 Feb.10 Byrnes MC, Irwin E, Carlson D, Campeau A, Gipson JC, Beal A, Croston JK. “Repair of high-risk incisional hernias and traumatic abdominal wall defects with porcine mesh.” Am Surg. 2011 Feb;77(2):144-50.11 Alicuben ET, DeMeester SR. “Onlay ventral hernia repairs using porcine non-cross-linked dermal biologic mesh.” Hernia. 2013 Feb. [Epub ahead of print].† Davol Inc. provided financial support in the form of a research fellow salary. † † Data on file at Davol but not published in this study.* Dr. Croston is a paid consultant for Davol Inc. Brennen Medical LLC, the former manufacturer of the XenMatrix™ Surgical Graft provided support for this study.

Indications

Intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including: abdominal plastic and reconstructive surgery; muscle flap reinforcement; hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias.

Contraindications

XenMatrix™ Surgical Graft should not be used on patients with known sensitivity to porcine products. Not for reconstruction of cardiovascular defects. Not for reconstruction of central nervous system or peripheral nervous system defects. Use of this product in applications other than those indicated has the potential for serious complications.

Warnings

If an infection develops, it should be treated aggressively. An allergic reaction, which is unrelated to other therapy, is an indication to consider removal of XenMatrix™ Surgical Graft.

Precautions

Place device in maximum possible contact with healthy, well-vascularized tissue to promote cell ingrowth and tissue remodeling. When unable to close skin over the XenMatrix™ Surgical Graft, ensure that the implant remains moist. Avoid drying of the implant through “continued suction devices” as this may negatively impact the performance of the implant. Only physicians qualified in the appropriate surgical techniques should use this surgical graft.

The surgeon should thoroughly understand the surgical procedure and the performance characteristics of the surgical graft.

Adverse Reactions

Potential complications with the use of any prosthesis may include, but are not limited to, allergy, seroma, infection, inflammation, adhesion, fistula formation, hematoma and recurrence of tissue defect.

Please consult package insert for more detailed safety information and instructions for use.


Davol Inc. • Subsidiary of C. R. Bard, Inc.100 Crossings Boulevard • Warwick, RI 028861.800.556.6275 • www.davol.comMedical Services & Support 1.800.562.0027

MMXMSS6

Bard, Davol and XenMatrix are trademarks and/or registered trademarks of C. R. Bard, Inc.

All other trademarks are the property of their respective owners.

© Copyright 2014, C. R. Bard, Inc. All Rights Reserved.

To learn more, contact your local Bard representative or call 1.800.556.6275

* Thickness 1.8 mm to 2.5 mm† Largest biologic graft available on the market for hernia repair. Source: IMS Data Q4 2013.

Product Code Quantity Shape Dimensions* Coverage Area

1160606 1/cs Square 2.4" x 2.4" (6x6 cm) 36 cm²

1160610 1/cs Rectangle 2.4" x 3.9" (6x10 cm) 60 cm²

1160808 1/cs Square 3.1" x 3.1" (8x8 cm) 64 cm²


1161010 1/cs Square 3.9" x 3.9" (10x10 cm) 100 cm²



1161028 1/cs Rectangle 3.9" x 11" (10x28 cm) 280 cm²



1162020 1/cs Square 7.9" x 7.9" (20x20 cm) 400 cm²


1161928 1/cs Rectangle 7.5" x 11" (19x28 cm) 532 cm²



1163030 1/cs Square 11.8" x 11.8" (30x30 cm) 900 cm²


† 1163045 1/cs Rectangle 11.8" x 17.7" (30x45 cm) 1350 cm²

Product Codes

Regenerative Collagen Matrix XenMatrix Surgical …...XenMatrix Surgical Graft Regenerative Collagen...

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