XenMatrix™ AB 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.1,2

Protection When And Where It’s Needed

XenMatrix™ AB 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.1,2 It uses a combination of well-characterized antibiotics, Rifampin and Minocycline, to offer an unmatched level of graft protection in challenging ventral hernia repair.

Protective Antibacterial Coating

The XenMatrix™ AB coating uses Rifampin and Minocycline, an antibacterial combination with demonstrated clinical results in other medical devices.3

  • Protects the graft prior to neovascularization.
  • Provides protection from biofilm formation caused by MRSA and E. coli.
  • Shown to reduce bacterial colonization in 5 different medical devices:

– Central Venous Catheters (CVC)       – External Ventricular Drain Catheters (EVD)

– Hemodialysis Catheters                      – Inflatable Penile Prostheses (IPP)

–  Cardiovascular Implantable Electronic 
    Device (CIED) Envelopes

 

• These devices coated with Rifampin and Minocycline are well-studied in clinical literature; 30
    publications including 67,000 patients and 6 randomized controlled trials.3

 

    – No instances of microbial resistance to the combination of Rifampin and Minocycline have been
       reported.

    – No complications or adverse events due to the antibiotic content for on-label use have been
       reported.

 

1IMS Data, Q2 2014, 510K search, fda.gov.

2Preclincal data on file; results may not correlate to clinical performance.

3 Literature search and analysis of Rifampin and Minocycline coated medical devices. Data on file. 2014

 

Ordering Information

    • 1150606
    • 1/cs.
    • 2.4" x 2.4" (6 cm x 6 cm) Square
    • 1150610
    • 1/cs.
    • 3.9" x 2.4" (6 cm x 10 cm) Rectangle
    • 1150616
    • 1/cs.
    • 6.3" x 2.4" (6 cm x 16 cm) Rectangle
    • 1150808
    • 1/cs.
    • 3.1" x 3.1" (8cm x 8cm) Square
    • 1151010
    • 1/cs.
    • 3.9" x 3.9" (10 cm x 10 cm) Square
    • 1151015
    • 1/cs.
    • 3.9” x 5.9” (10 cm x 15 cm) Rectangle
    • 1151020
    • 1/cs.
    • 3.9” x 7.9” (10 cm x 20 cm) Rectangle
    • 1151028
    • 1/cs.
    • 3.9” x 11” (10 cm x 28 cm) Rectangle
    • 1151520
    • 1/cs.
    • 5.9" x 7.9" (15 cm x 20 cm) Rectangle
    • 1151525
    • 1/cs.
    • 5.9” x 9.8” (15 cm x 25 cm) Rectangle
    • 1151928
    • 1/cs.
    • 7.5" x 11" (19 cm x 28 cm) Rectangle
    • 1151935
    • 1/cs.
    • 7.5" x 13.8" (19 cm x 35 cm) Rectangle
    • 1152020
    • 1/cs.
    • 7.9” x 7.9” (20 cm x 20 cm) Rectangle
    • 1152025
    • 1/cs.
    • 7.9” x 9.8” (20 cm x 25 cm) Rectangle

Accessories

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. 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:

  1. XenMatrix™ AB Surgical Graft should not be used on patients with known sensitivity to porcine products.
  2. Do not use in patients with allergy, history of allergy or hypersensitivity to tetracyclines or rifamycins or other components in the device.
  3. Do not use in pregnant or nursing women.
  4. 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. For reference the contraindications for Minocycline and Rifampin are as follows: Contraindications for Oral Capsule (1 mg/kg) of Minocycline: • This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. Contraindications for both IV (600mg) and Oral Capsule (150mg- 300mg) of Rifampin: • Rifampin is contraindicated in patients with a history of hypersensitivity to rifampin or any of the components, or to any of the rifamycins. 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. Patients implanted with the largest product size (19 cm x 35 cm) are calculated to receive a one time total dose of approximately 177 mg each of Rifampin and Minocycline. This is in contrast to typical treatment doses, which are 600 mg for Rifampin and 200 mg for Mino

Warnings:

  1. This device is not indicated for the treatment of infection. If an infection develops, treat the infection aggressively.
  2. 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.
  3. An allergic reaction that is unrelated to other therapy is an indication to consider removal of XenMatrix™ AB Surgical Graft. 
  4. Do not use this product in patients with allergy, history of allergy or hypersensitivity to tetracyclines or rifamycins or other components of the device. 5. The safety and performance of XenMatrix™ AB Surgical Graft in pediatric patients has not been evaluated.

Precautions:

  1. The use of this product in patients with compromised hepatic function should be carefully considered since Rifampin can cause additional stress to hepatic metabolism. Rifampin given at systemic therapeutic doses over multiple days, has been shown to produce liver dysfunction. Fatalities associated with jaundice have occurred in patients with liver disease and in patients taking Rifampin with other hepatotoxic agents. Patients with impaired liver function should be given Rifampin systemically only in cases of necessity and then with caution and under strict medical supervision. In these patients, careful monitoring of liver function, especially SGPT/ ALT and SGOT/AST should be performed prior to therapy.
  2. Do not alter practice of pre-, peri-, or postoperative administration of local or systemic antibiotics.
  3. Place device in maximum possible contact with healthy, well-vascularized tissue to promote cell ingrowth and tissue remodeling.
  4. When unable to close skin over the XenMatrix™ AB 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.
  5. Due to the orange color in the coating, hydration solution and fluid from surgical drains may be tinted orange.

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.

DAV/XNAB/1114/0040(2)