INDICATIONS, SAFETY, AND WARNINGS TYRX Cardiac Absorbable Antibacterial Envelope

INDICATIONS FOR USE

The TYRXTM Absorbable Antibacterial Envelope is intended to hold a pacemaker pulse generator or defibrillator securely in order to provide a stable environment when implanted in the body. The absorbable antibacterial envelope 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.

CAUTIONS

Only physicians qualified in the placement of pulse generators or defibrillators should use this prosthesis.

CONTRAINDICATIONS

The Absorbable Antibacterial Envelope 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
  • Contaminated or infected wounds

POTENTIAL COMPLICATIONS

Possible complications for these procedures include bleeding and infection. (See also WARNINGS.) There is currently no long-term data available to determine whether tissue reactions to the absorbable antibacterial envelope 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 Medtronic, Inc. at 1-800-848-9300.

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 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.

This device has not been evaluated in pediatric patients.

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 absorbable antibacterial 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 the absorbable antibacterial envelope in contaminated wounds is not recommended. The device is not indicated for the treatment of infection. Because the absorbable antibacterial envelope 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.