XenMatrix™ AB Surgical Graft

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

2 Preclincal 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

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.
   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.
5. Patients implanted with the largest product size (30 cm x 45 cm) are calculated to receive a one time total dose of approximately 327 mg each of Rifampin and Minocycline. This is in contrast to typical systemic treatment doses, which are 600 mg for Rifampin and 200 mg for Minocycline administered multiple times per day, over several days to several months.

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. 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.
4. 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.
5. Do not use this product in patients with allergy, history of allergy or hypersensitivity to tetracyclines or rifamycins or other components of the device.
6. The safety and performance of XenMatrix™ AB Surgical Graft in pediatric patients has not been evaluated.

Precautions:

Do 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.

WARNING: This product can expose you to Rifampin and Minocycline HCL, which are known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.

BD-14768