Antibacterial-Coated Regenerative Collagen Matrix€¦ · 3 Arielle E Kantners, BS, David M Krpata, MD, Jeffrey A Blatnik, MD, Yuri M Novitsky, MD, Michael J Rosen, MD, FACS

SOFT TISSUE REPAIRRight Procedure. Right Product. Right Outcome.

Antibacterial-Coated Regenerative Collagen Matrix

Protection when and where it’s needed

XenMatrix™ AB Surgical Graft is the first antibacterial-coated, non-crosslinked porcine dermal graft proven to inhibit the colonization of MRSA, E. coli, and other bacteria in preclinical models.* It uses a combination of well-characterized antibiotics, Rifampin and Minocycline, to offer an unmatched level of graft protection in challenging ventral hernia repair. In vitro testing demonstrated a significant (p<0.0001) zone of inhibition against the most common bacteria associated with hernia-related complications.4

Demonstrated Graft Protection Preclinical testing demonstrated that Rifampin and Minocycline provided immediate protection to the XenMatrix™ AB Surgical Graft for 7 days against MRSA, E. coli, and VRE, the most common bacteria associated with hernia related complications.*

Early Clinical Data• Clinical data show XenMatrix™ AB was

associated with a low rate of postoperative complications during the first 30 days.1

Demonstrated Preclinical Results*

• Preclinical data show XenMatrix™ AB completely inhibits bacterial colonization on the graft in the presence of MRSA and E. coli.**2

• Preclinical data show XenMatrix™ AB exhibits a reduced inflammatory response when compared to an uncoated xenograft.3

The First and Only

Protection when and where it’s needed

* Preclinical data on file. May not correlate to results in humans.** No hernia mesh is indicated for use in contaminated or infected fields.

1 Baker, et. al. Early clinical outcomes of a novel antibiotic-coated non-crosslinked porcine dermal graft following complex abdominal wall reconstruction. JACS. 2016 223; 4 581-586. 2 Majumder, Arnab, Novitsky, Yuri W., et. al. Evaluation of the Antimicrobial Efficacy of a Novel Rifampin/Minocycline-Coated, Noncrosslinked Porcine Acellular Dermal Matrix

Compared with Uncoated Scaffolds for Soft Tissue Repair. Surgical Innovation. 2016; 1-14.3 Cohen, Leslie E., Spector, Jason A., et al. Comparison of Antibiotic-Coated versus Uncoated Procine Dermal Matrix. American Society of Plastic Surgeons. 2016 138; 5: 844-855.4 ZOI preclinical information demonstrates the effectiveness of rifampin and minocycline against bacteria on the graft, not the surrounding tissues.

** No hernia mesh is indicated for use in contaminated or infected fields.

1 Belyansky, Igor, et al. Lysostaphin-coated mesh prevents staphylococcal infection and significantly improves survival in a contaminated surgical field. The American Surgeon 2011 77;8: 1025-1031.

2 Krpata, David M., et al. Evaluation of high-risk, comorbid patients undergoing open ventral hernia repair with synthetic mesh. 2012 Surgery. (153): 120-125 3 Arielle E Kantners, BS, David M Krpata, MD, Jeffrey A Blatnik, MD, Yuri M Novitsky, MD, Michael J Rosen, MD, FACS. Modified Hernia Grading Scale to Stratify Surgical Site

Occurrence after Open Ventral Hernia Repair. 2012 American College of Surgeons, 215; 6 787-7934 Breuing K, et al. Incisional ventral hernias: Review of the literature and recommendations regarding the grading and technique of repair. Surgery; 1-15 (2010).5 Pierce R, et al. 120-day comparative analysis of adhesion grade and quantity, mesh contraction, and tissue response to a novel omega-3 fatty acid bioabsorbable barrier

Macroporous mesh after intraperitoneal placement. Surgical Innovation; 1-9 (2009).6 Poulose BK, Shelton J, Phillips S, Moore D, Nealon W, et al. Epidemiology and cost of ventral hernia repair: making the case for hernia research. Hernia 16 (2): 179-183 (2012).

Addressing Complex Problems

Ventral Hernia Challenges

• Challenging surgical environment

• Transient bacterial contamination occurs in every operation1

• MRSA and E. coli are the most common bacteria associated with hernia-related complications1

As complexity of patient conditions increase, so does the risk for an SSIIt is estimated that more than 75% of all recurrences are due to infection and inadequate repair.4 Because of frequent recurrence, these hernias are associated not only with high rates of reoperation and morbidity but also with significant yearly health care expenditures.5 Every 1% reduction achieved through reduced recurrence rates in ventral hernia repair could potentially save an estimated $32 million in yearly procedure costs.6

Clean-Contaminated Contaminated Dirty**

SSO = 46%

Smoker • Obese • COPD • DMHistory of Wound Infection

SSO = 27%

Low Risk of ComplicationsNo History of Wound Infection

SSO = 14%

an-Contamina

GRADE

3

• Obese • CO

GRADE

2

Risk of Complic

GRADE

1

COM

PLEX

ITY

Patient Grade Classification1

Two or more comorbidities may result in two-fold increase in wound morbidity2

Examples of comorbidities include:

• Obesity

• Chronic Obstructive Pulmonary Disorder (COPD)

• Immunosuppression

• History of smoking

• Prior hernia repair

Preclinical Data

Zone of Inhibition1 In a preclinical* study using 70 standard Mueller-Hinton agar plates inoculated with either MRSA or E. coli, XenMatrix™ AB Surgical Graft demonstrated a significantly greater Zone of Inhibition (ZOI) against clinically- isolated MRSA, as compared to all other non-coated devices evaluated which demonstrated no ZOI.

* Preclinical data on file. May not correlate to results in humans.

1 ZOI preclinical information demonstrates the effectiveness of rifampin and minocycline against bacteria on the graft, not the surrounding tissues.

2 Cohen, Leslie E., Spector, Jason A., et al. Comparison of Antibiotic-Coated versus Uncoated Porcine Dermal Matrix. American Society of Plastic Surgeons. 2016 138;5: 844-855.

Handling PropertiesXenMatrix™ AB Surgical Graft is thinner than XenMatrix™, which may contribute to improved handling and suturability.2

Repair Strength Tissue ingrowth is required for a strong, long term repair. The repair strength of XenMatrix™ AB Surgical Graft is more than 3x stronger than native porcine abdominal wall at 12 weeks.*

0

20

40

60

80

100

120

140

150

160Repair Strength at 12 weeks

XenMatrix™

Surgical GraftStrattice™ Firm

Porcine Abdominal Wall Strength

Ball Bu

rst S

treng

th (N

)

The chart above represents approximately 68% and 78% reduction in burst strength of XenMatrix™ AB Surgical Graft versus Strattice™ Firm. At 12 weeks, XenMatrix™ AB demonstrated a significantly lower strength reduction over time relative to Strattice™ Firm (p<0.05).

0

10

20

30

40Zone of Inhibition (ZOI) Study* Results

XenMatrix™ AB

NO ZONE OF INHIBITION ESTABLISHED

ZOI (

mm

)Strattice™ Firm Permacol™ Surgimend™ XCM™ BIO-A™

Threshold

Early Clinical Results

1 Baker, et. al. Early clinical outcomes of a novel antibiotic-coated non-crosslinked porcine dermal graft following complex abdominal wall reconstruction. JACS. 2016 223; 4 581-586.

* No hernia mesh is indicated for use in infected fields.

First Published XenMatrix™ AB Patient Data1

• 6 month retrospective, multicenter review of 74 patients

• Large defects (median hernia size/area was 66 cm2)

• 21.6% had previous wound infection

• 21.6% had a violation of the gastrointestinal tract during hernia repair

• 10.8% required >1 piece of mesh

• 70.3% were performed open repair, 29.7% underwent laparoscopic repair

In this multicenter study by Baker, et. al., data suggest the use of XenMatrix™ AB Surgical Graft was associated with 0.0% SSIs at 6 months.1

Early clinical outcomes of a novel antibiotic-coated non-crosslinked porcine dermal graft following complex abdominal wall reconstruction.

Outcomes from 0-6 Months1

Surgical Site Occurrence 0-6 Months

Surgical Site Infection 5 (6.8%)

Seroma 7 (9.5%)

Recurrence 4 (5.4%)

Reoperation 2 (2.7%)

CDC Surgical Wound Classification

Wound Classification Number of Patients

I. Clean 20 (27.0%)

II. Clean contaminated 9 (12.2%)

III. Contaminated* 6 (8.1%)

IV. Dirty infected* 4 (5.4%)

Unknown 35 (47.3%)

Product Code Quantity Shape Dimensions* Coverage

Area

1150606 1/cs Square 2.4" x 2.4" (6 cm x 6 cm) 36 cm²

1150608 1/cs Rectangle 2.4" x 3.1" (6 cm x 8 cm) 48 cm²


1150808 1/cs Square 3.1" x 3.1" (8cm x 8cm) 64 cm²






1151028 1/cs Rectangle 3.9" x 11" (10 cm x 28 cm) 280 cm²






1151928 1/cs Rectangle 7.5" x 11" (19 cm x 28 cm) 532 cm²


1152530 1/cs Rectangle 9.8" x 11.8" (25 cm x30 cm) 750 cm²





XenMatriX aB™ Surgical GraftIndications 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. The Rifampin and Minocycline coating has been shown in preclinical in vitro and in vivo testing to reduce or inhibit microbial colonization on the device. The claim of reduction of bacterial colonization of the device has not been established with human clinical data, nor has a clinical impact associated with this claim been demonstrated.

Contraindications XenMatrix™ AB Surgical Graft should not be used on patients with known sensitivity to porcine products.

Do not use in patients with allergy, history of allergy or hypersensitivity to tetracyclines or rifamycins or other components in the device.

Do not use in pregnant or nursing women.

The contraindications, warnings and precautions regarding the use of the antimicrobial agents Rifampin (a derivative of rifamycinB) and Minocycline (a derivative of tetracycline) apply and should be considered when using this device. See FDA’s drug labeling database for Rifampin and Minocycline labeling.

The use of this product in patients with compromised hepatic function should be carefully considered since rifampin can cause additional stress to hepatic metabolism. Implantation of this device would not result in detectable systemic concentrations of Rifampin or Minocycline.

Warnings This device is not indicated for the treatment of infection. If an infection develops, treat the infection aggressively.

To minimize recurrences when repairing hernias, the graft should be large enough to provide sufficient overlap beyond the margins of the defect on all sides.

Prior to use, carefully examine package and product to verify neither is damaged and that all seals are intact. Do not use if the package is damaged or open.

Postoperative signs of toxicity, as possibly evidenced by worsening renal or hepatic function, or an allergic reaction that is unrelated to other therapy is an indication to consider removal of XenMatrix™ AB Surgical Graft.

Do not use this product in patients with allergy, history of allergy or hypersensitivity to tetracyclines or rifamycins or other components of the device.

The safety and performance of XenMatrix™ AB Surgical Graft in pediatric patients has not been evaluated.

PrecautionsDo not alter practice of pre-, peri-, or postoperative administration of local or systemic antibiotics.

Adverse Reactions Potential complications with the use of any prosthesis may include, but are not limited to, allergic reaction or hypersensitivity to device materials or antimicrobial coating, seroma, infection, inflammation, adhesion, fistula formation, hematoma, and recurrence of tissue defect.

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

DAV/XNAB/1216/0131

To learn more, contact your local Bard Representative or call 1.800.556.6275.

Please consult product labels and inserts for any indications, contraindications, hazards, warnings, precautions and instructions for use.

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 2017, C. R. Bard, Inc. All Rights Reserved.

* Thickness 1.8 mm to 2.5 mm

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Antibacterial-Coated Regenerative Collagen Matrix€¦ · 3 Arielle E Kantners, BS, David M Krpata, MD, Jeffrey A Blatnik, MD, Yuri M Novitsky, MD, Michael J Rosen, MD, FACS