Microsoft word - lbl-0869 rev 1 - aigisrx r instructions for use _us_.docx
TYRX® Brand AIGIS Rx R Fully Resorbable Antibacterial Envelope
(Antibacterial, Polymer-Coated Bioresorbable Envelope
Containing the Antimicrobials Rifampin and Minocycline)
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 R is a fully resorbable sterile prosthesis designed to hold a pacemaker pulse generator or defibrillator to create
a stable environment when implanted in the body. AIGISRxR is constructed from multifilament knitted mesh (polymer made of glycolide, caprolactone, and trimethylene carbonate) that is coated with a bioresorbable polyarylate polymer. The AIGIS Rx R bioresorbable polymer coating
contains antimicrobial agents in concentrations of 8.0 mg rifampin and 5.1 mg minocycline (Medium size), and 11.9 mg rifampin and 7.6 mg minocycline (Large size). INDICATIONS FOR USE AIGIS Rx R is intended to securely hold a pacemaker pulse generator or defibrillator in order to provide a stable
environment when implanted in the body. AIGIS Rx R contains the antimicrobial agents rifampin and minocycline, which
have been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of the generator or defibrillator. This device is only intended to be used in conjunction with pacemakers and implantable defibrillators. ACTIONS AIGISRxR is constructed of knitted filaments of standard, bioresorbable suture materials (a combination of glycolide, caprolactone, and trimethylene carbonate) that are coated with a bioresorbable polyarylate polymer. The purpose of the resorbable coating is to act as a carrier for the antimicrobial agents. Animal data demonstrates that the AIGISRxR device resorbs in approximately 9 weeks. AIGISRx R releases the antimicrobial agents rifampin and minocycline to reduce the risk of infection of the implanted pulse generator following surgery. In in vitro studies, AIGIS Rx R demonstrated antimicrobial activity against Staphylococcus aureus, methicillin-resistant Staphylococcus aureus (MRSA), Staphylococcus epidermidis, Staphylococcus lugdunensis, Escherichia coli, and Acinetobacter baumannii. AIGISRxR also demonstrated in vivo effectiveness in reducing infections in a series of studies in which a pulse generator canister placed into an AIGIS Rx R envelope and a generator canister alone (control) were implanted into an
appropriate model of infectivity (rabbits). Both the AIGIS Rx R and the control groups were inoculated with bacteria and
observed for a minimum of 7 days to document the presence or absence of infection in the animals. The bacteria tested included methicillin-resistant Staphylococcus aureus (MRSA), Staphylococcus aureus, Staphylococcus epidermidis, Acinetobacter baumannii,Escherichia coli, and Staphylococcus lugdunensis, which represent a majority of the pathogens reported in pacemaker and defibrillator infections.
It should be noted that in the in vitro and in vivo activity of the AIGISRxR antimicrobials is variable against non- epidermidis and non-lugdunensis strains of coagulase-negative staphylococci. CONTRAINDICATIONS AIGISRxR is NOT indicated for use in the following situations:
Allergy or history of allergy to tetracyclines, rifampin, or resorbable sutures
In patients with systemic lupus erythematosus (SLE) because minocycline has been reported to
aggravate this condition. 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 resterilize. Product should be used once 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 surgical 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, including removal of the prosthesis, if indicated. As in any antimicrobial therapy, the possible teratogenic potential in women capable of having children should be carefully weighed against the benefit of therapy. 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 carefully considered because rifampin and minocycline can cause additional stress on the hepatic and renal systems. Patients who are implanted with this device and are also receiving methoxyflurane should also be carefully monitored for signs of renal toxicity. 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 potentiate the anticoagulant effect of warfarin. 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. The contraindications, warnings and precautions applicable to the use of specific antibiotic prophylaxis should be followed when prophylaxis is administered in conjunction with implantation of a pacemaker pulse generator or defibrillator enclosed in an AIGISRxR Envelope. Development of a hypersensitivity reaction should be followed by removal of the device and appropriate treatment initiated at the discretion of the attending physician.
Use of AIGISRxR in contaminated wounds is not recommended. The device is not indicated for the treatment of infection. Because the AIGISRxR is impregnated with a combination of the antimicrobial agents rifampin (a derivative of rifamycin B) 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. CAUTIONS Only physicians qualified in the placement of pulse generators or defibrillators should use this prosthesis. Rx Only 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 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.) There is currently no long-term data available to determine whether tissue reactions to the AIGISRxR device will be equivalent to the Parsonnet™ pacemaker pouch. As with any surgical procedure involving the implantation of a pacemaker/defibrillator, there may be complications, including seroma, adhesions, hematoma, inflammation, extrusion, or fistula formation. If infection develops, treat the infection aggressively as per standard practice, including removal of the prosthesis, if indicated. Please report any device-related adverse events to TYRX, Inc. at 1.866.908.8979 or electronically at [email protected] STORAGE AIGISRx R 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. If infection develops, treat the infection aggressively as per standard practice, including removal of the prosthesis if indicated. PRODUCT SELECTION AIGISRx R Medium(PM) is intended to hold a pacemaker pulse generator. AIGISRx RLarge (ICD) is intended to hold a defibrillator. PREPARATION It is recommended that AIGIS Rx R be completely immersed in standard irrigation solution for a few seconds to
facilitate placement. INSERTION TECHNIQUE Prepare the pulse generator or defibrillator as per manufacturer’s instructions, making sure to secure the leads. Slide the pulse generator/defibrillator into the opening in the envelope with lead wires emerging straight out as shown in Figure 1. Place generator/defibrillator into the patient as per standard practice. If the dimensions of the pulse generator/defibrillator are larger than the opening, but of similar dimension to the AIGISRx R, the opening can be widened to accommodate placement. (NOTE: AIGISRxR cannot be used with generators and defibrillators that are larger than its internal dimensions.) For generators and defibrillators that are significantly smaller than AIGIS Rx R, the generator/defibrillator should be placed as shown in Figure 2. Nonabsorbable or absorbable
monofilament sutures can be used to tack the opening of the envelope to secure the generator/defibrillator prior to implantation.
REMOVAL OF PULSE GENERATOR FROM INCORPORATED ENVELOPE It may be necessary to remove the pacemaker or defibrillator from the envelope after a period of implantation. AIGIS Rx R is designed to facilitate explants by use of the bioresorbable mesh. Should it be necessary to remove
the pacemaker or defibrillator prior to full resorption of the envelope, first surgically expose the envelope. Make an incision on the flat side of the envelope, approximately the width of the pacemaker or defibrillator. Disconnect the electrode leads. Remove the pacemaker/defibrillator through the opening in the side of the envelope. If required, insert a drainage tube. A new pacemaker/defibrillator may be inserted into the envelope through the side opening. Connect the electrical leads. Suture the envelope closed. Complete the procedure following standard accepted surgical techniques. Familiarization with the device and following proper surgical techniques are important when explanting a device. Always use standard of care subject to the patient’s condition and the surgical presentation in removing an implant. TRACEABILITY A traceability label, which identifies the type, size and lot number of the AIGISRx R prosthesis, is attached to the foil label on every package. This traceability label should be peeled off and affixed to the patient’s permanent medical record to clearly identify the device that was implanted. HOW SUPPLIED AIGISRx R is supplied sterile, in foil pouches, in two sizes: a Medium and Large envelope.
Manufactured by TYRX, Inc. 1 Deer Park Drive • Suite G Monmouth Junction, New Jersey 08852 USA CUSTOMER SERVICE 1.866.908.8979 PHONE 1.732.246.8676 FAX 1.732.246.8677 www.TYRX.com TYRX products are protected under one or more patents, which can be found at www.TYRX.com. Copyright 2013, TYRX, Inc. All rights reserved. LBL-0869 Rev 1
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