INDICATIONS, SAFETY, AND WARNINGS TYRX Neuro Absorbable
Antibacterial Envelope

INDICATIONS FOR USE

The TYRX™ Neuro Absorbable Antibacterial Envelope is intended to hold a vagus nerve stimulator, a spinal cord neuromodulator, a deep brain stimulator or a sacral nerve stimulator securely in order to create a stable environment when implanted in the body. The 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 a pulse generator. 


CONTRAINDICATIONS

The TYRX Neuro Antibacterial Envelope is NOT indicated for use in patients who have an allergy or history of allergies to tetracyclines, Rifampin, or absorbable sutures. The Neuro Antibacterial Envelope is also NOT indicated for use in patients with contaminated or infected wounds, or Systemic Lupus Erythematosus (SLE). This device is intended to be used in conjunction with vagus nerve stimulators or deep brain stimulators implanted in the infraclavicular fossa, or in conjunction with spinal cord neuromodulators or sacral nerve stimulators implanted laterally to the body midline and slightly superior to the gluteal region. 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 Neuro Antibacterial Envelope and who are also taking methoxyflurane should be monitored carefully for signs of renal toxicity.

The TYRX Cardiac and Neuro Absorbable Antibacterial Envelopes are NOT indicated for use in patients who have an allergy, or history of allergies, to tetracyclines, Rifampin, or absorbable sutures. The TYRX Cardiac and Neuro Absorbable Antibacterial Envelopes are also NOT indicated for use in patients with contaminated or infected wounds, or Systemic Lupus Erythematosus (SLE). The use of these products 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 a TYRX Cardiac and Neuro Absorbable Antibacterial Envelope, and who are also taking methoxyflurane, should be monitored carefully for signs of renal toxicity.