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.
Contents sterile unless package has been opened or damaged. Single Use Only. Do Not Resterilize.
Read instructions prior to use.
Rx Only PRODUCT DESCRIPTION
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.
is constructed from multifilament knitted mesh (polymer made of glycolide, caprolactone, and trimethylene
carbonate) that is coated with a bioresorbable polyarylate polymer. The AIGIS
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
is intended to securely hold a pacemaker pulse generator or defibrillator in order to provide a stable
environment when implanted in the body. AIGIS
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
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 AIGISRx R
device resorbs in approximately 9 weeks.
releases the antimicrobial agents rifampin and minocycline to reduce the risk of infection of the implanted
pulse generator following surgery. In in vitro
demonstrated antimicrobial activity against
methicillin-resistant Staphylococcus aureus
(MRSA), Staphylococcus epidermidis,
Staphylococcus lugdunensis, Escherichia coli, and Acinetobacter baumannii.
also demonstrated in vivo
effectiveness in reducing infections in a series of studies in which a pulse
generator canister placed into an AIGIS
envelope and a generator canister alone (control) were implanted into an
appropriate model of infectivity (rabbits). Both the AIGIS
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 AIGISRx R
antimicrobials is variable against non-epidermidis
strains of coagulase-negative staphylococci.
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.
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 AIGISRx R
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 AIGISRx R
in contaminated wounds is not recommended. The device is not indicated for the treatment of
infection. Because the AIGISRx R
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.
Only physicians qualified in the placement of pulse generators or defibrillators should use this prosthesis.
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 AIGISRx R
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.
Use clean, sterile gloves and/or atraumatic instruments when handling the mesh.
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.
AIGISRx R Medium (PM)
is intended to hold a pacemaker pulse generator. AIGISRx R Large (ICD)
is intended to
hold a defibrillator.
It is recommended that AIGIS
be completely immersed in standard irrigation solution for a few seconds to
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: AIGISRx R
cannot be used with generators and defibrillators
that are larger than its internal dimensions.) For generators and defibrillators that are significantly smaller than AIGIS
, 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
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.
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.
is supplied sterile, in foil pouches, in two sizes: a Medium and Large envelope.
1 Deer Park Drive • Suite G
Monmouth Junction, New Jersey 08852 USA
CUSTOMER SERVICE 1.866.908.8979
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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