CMRM6122

TYRX absorbable antibacterial envelope with an electronic device inside

Indications, Safety, and WarningsIf you are located in the United States, please refer to the brief statement(s) below to review applicable indications, safety, and warning information. See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events.If you are located outside the United States, see the device manual for detailed information regarding instructions for use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. If using an MRI SureScan™ device, see the MRI SureScan™ technical manual before performing an MRI.Brief statementThe TYRX™ 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 TYRX™ absorbable antibacterial envelope contains the antimicrobial agents minocycline and rifampin, which have been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of the generator or defibrillator. The TYRX™ absorbable antibacterial envelope is not indicated for use in patients who have an allergy or history of allergies to tetracyclines, rifampin, or absorbable sutures. The TYRX™ absorbable antibacterial envelope is also not indicated for use in patients with contaminated or infected wounds, or systemic lupus erythematosus (SLE). 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 minocycline and rifampin can cause additional stress on the hepatic and renal systems. Patients who receive the TYRX™ absorbable antibacterial envelope and who are also taking methoxyflurane should be monitored carefully for signs of renal toxicity.Caution: Federal (United States) law limits the device to sale by, or on the order of, a licensed practitioner.For full prescribing information, including warnings, cautions, and contraindications, see the instructions for use.

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