TYRX® Brand AIGIS ® Rx ST Antibacterial Soft Tissue Repair Device
Minocycline and Rifampin eluting polypropylene mesh sheet
Manufactured and distributed by: TYRX, Inc.
STERILE: Contents sterile unless package has been opened or damaged. Single use Only. Do not Resterilize. CAUTION: Read instructions prior to use. Rx Only
PRODUCT DESCRIPTION AIGIS ® Rx ST is a dual component (resorbable and non-resorbable), sterile prosthesis designed to reinforce soft
tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue. AIGIS ® ST is constructed of knitted filaments of polypropylene that are coated with a bioresorbable
polyarylate polymer. AIGIS ® ST bioresorbable polymer coating contains the antimicrobial agents rifampin and minocycline in
concentrations of 86 µg/cm2. INDICATIONS FOR USE AIGIS ® ST is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for
the surgical repair of damaged or ruptured soft tissue. Indications for use include the repair of soft tissue defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. The AIGIS ® ST resorbable polymer coating contains the antimicrobial agents rifampin and minocycline to help
provide protection from microbial colonization of the device during surgical implantation. ACTIONS AIGIS ® ST is constructed of knitted filaments of polypropylene that are coated with a bioresorbable
polyarylate polymer. The purpose of the resorbable coating is to act as a carrier for the antimicrobial agents. Once placed, the polymer resorbs in approximately 90 days, leaving a lightweight permanent mesh incorporated into the tissue. AIGIS ® Rx ST releases the antimicrobial agents rifampin and minocycline for a minimum of 7 days to reduce the
risk of infection following surgery. In in vitro studies, AIGIS ® ST demonstrated antibacterial activity against
methicillin-resistant Staphylococcus aureus and Staphylococcus epidermidis. The design of AIGIS ® ST is based upon an AIGISRx product developed for use with implanted electronic
devices. AIGIS
demonstrated in vivo effectiveness in reducing infections in a series of animal studies in
which a surgically implanted electronic device was placed into the AIGIS ®
pouch configuration. The control arm was a surgically implanted electronic device alone. The devices were implanted into appropriate animal models of infectivity (dogs or rabbits). Both the pouch and control implant sites were inoculated with 105 CFU of Staphylococcus aureus bacteria and observed for a minimum of 7 days to demonstrate the absence of infection in the animals. It should be noted that the in vitro and in vivo activity of the antimicrobials is variable against non-epidermidis strains of coagulase-negative staphylococci.
CONTRAINDICATIONS AIGIS ® Rx ST is contraindicated for use in the following situations:
• In the reconstruction of cardiovascular defects
• In infants or children with future growth potential
• Allergy or history of allergy to tetracyclines, or rifampin.
• In patients with systemic lupus erythematosus (SLE), because minocycline has been reported to
Rx ST indications for use include the repair of soft tissue defects which require the use of reinforcing or
bridging material to obtain the desired surgical outcome. The device is not indicated for the treatment of infection. Because the AIGIS ® ST is coated with a polyarylate polymer mixture of the antimicrobial agents rifampin (a
derivative of rifamycinB) and minocycline (a derivative of tetracycline), the contraindications, warnings and precautions regarding the use of these antimicrobials apply, and should be adhered to when using this device, even though systemic levels of minocycline and rifampin in patients receiving this device are not likely. WARNINGS This device is supplied sterile. Inspect the packaging to be sure that it is intact and undamaged prior to use. This device is for single use only. Do not re-sterilize. Product should be used at the time the exterior foil wrapper has been broken. Do not store for later use. Unused portions of the prosthesis should be discarded. If the unused prosthesis has been in contact with instruments or supplies used on a patient or contaminated with bodily fluids, discard with care to prevent risk of transmission of any disease.
The use of any permanent mesh in a contaminated or infected wound could lead to fistula formation and extrusion of the prosthesis. If infection develops, treat the infection aggressively as per standard practice. The prosthesis may not require removal; however, an unresolved infection may require removal of the prosthesis. As in any antibacterial therapy, the possible teratogenic potential in women of childbearing age should be weighed carefully against the benefit of therapy. Even though systemic levels of minocycline and rifampin in patients receiving this device are not likely, the use of this product in patients with compromised hepatic and renal function, or in the presence of hepatotoxic or renal toxic medications, should be considered carefully because rifampin and minocycline can cause additional stress on the hepatic and renal systems. Patients who are implanted with this device and who are also taking methoxyflurane should be monitored carefully for signs of renal toxicity. Minocycline is a known sclerosing agent, and the use of AIGIS ® ST in proximity to blood vessels should
therefore be considered carefully. Patients who are implanted with this device who are also taking warfarin should have their International Normalized Ratio (INR) monitored, because tetracyclines have been reported to slow coagulation. The use of this product in patients being treated with thionamides, isoniazid, or halothane should be carefully considered due to potential hepatic side effects that have been reported in patients using these drugs and higher doses of rifampin. Development of a hypersensitivity reaction should be followed by removal of the device and appropriate treatment initiated at the discretion of the attending physician. For AIGIS ® Rx ST, it is recommended practice to use the complete device to obtain the full effect of the labeled
antibiotic dosage. Use of AIGIS ® ST in contaminated wounds is not recommended. because in a contaminated wound ST may adversely affect proper wound healing and integration into the tissue and may result in the Rx ST should not be placed in proximity to internal viscera to minimize the potential for complications
including adhesions. AIGIS ® Rx ST should not be implanted inside the peritoneum or pleural membrane. CAUTIONS Only physicians qualified in the placement of soft tissue patches or in the practice of soft tissue repair should use this prosthesis. Positioning and suturing of AIGIS ® Rx ST will determine the level of stability obtained.
There are no known interactions between rifampin and minocycline. As with many drugs, the effectiveness of minocycline and rifampin may be reduced after direct contact with solutions containing iodine. Do not alter the usual practice of pre-, peri-, or post-operative administration of local or systemic antibiotics. COMPLICATIONS AND ADVERSE REACTIONS Possible complications for these procedures include bleeding and infection. (See WARNINGS.) Currently, there are no long-term data available to determine whether tissue reactions to the AIGIS ® ST device will be
equivalent to other polypropylene mesh devices. As with any surgical procedure involving the implantation of a polypropylene mesh device, there may be complications that include seroma, adhesions, hematoma, inflammation, extrusion, or fistula formation. Any unresolved infection may require removal of the prosthesis. Please report any device-related adverse events to TYRX at 1.866.908.8979 or via e-mail at safety@tyrx.com. STORAGE: AIGIS ® Rx ST should be stored between 36 – 77 ºF (2 – 25 ºC). DO NOT FREEZE.
HANDLING: Use clean, sterile gloves and/or atraumatic instruments when handling the mesh. MAINTAINING ASEPSIS To help maintain strict asepsis during surgery, special precautions and careful preoperative site preparations are necessary. Any postoperative infection should be treated aggressively and as soon as possible. Any unresolved infection may require removal of the prosthesis. PREPARATION It is recommended that AIGIS ® Rx ST be completely immersed for a few seconds in a standard irrigation
solution to facilitate placement. AIGIS ® ST is meant to provide physicians an option for different patient
presentations. Each device should be used in accordance with the individual institution’s standard of care.
TRACEABILITY A traceability label, which identifies the type, size and lot number of the prosthesis, is attached to the foil label in every package. This label should be peeled off the backing, and affixed to the patient’s permanent medical record to identify clearly the device that was implanted. HOW SUPPLIED AIGIS ® Rx ST units are supplied sterile in foil pouches in three sizes, a small, medium and large flat sheet
mesh. Manufactured by TYRX, Inc. 1 Deer Park Drive • Suite G Monmouth Junction, New Jersey 08852 CUSTOMER SERVICE 1.866.908.8979 PHONE 1.732.246.8676 FAX 1.732.246.8677
TYRX Products are protected under one or more of these patents: U.S. Patent Nos. 6120491, RE37160 Copyright 2011, TYRX, Inc. All rights reserved. RMS-0848 Rev 2
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