12.09.13
Monmouth Junction, N.J.-based TYRX Inc.’s AigisRx N antibacterial envelope has been awarded 510(k) clearance for expanded indications from the U.S. Food and Drug Administration (FDA). Expanded indications allow the product to be used to help reduce surgical site infections associated with implantable devices in the fields of neurosurgery and cardiology. This comes after the product’s recent clearance for use with vagus nerve stimulators.
The AigisRx N antibacterial envelope is intended to hold a spinal cord neuromodulator or vagus nerve stimulator securely in order to provide a stable environment when implanted in the body. The envelope contains the antimicrobial agents rifampin and minocycline, which are released locally into the tissue.
“Surgical site infections are growing much faster than the underlying rate of surgical procedures, with patients often suffering catastrophic consequences,” stated Robert White, TYRX president and CEO. “Securing this expanded FDA clearance is another key milestone for TYRX in our quest to reduce surgical site infections where the clinical and economic consequences associated with infection are significant.”
TYRX makes implantable combination drug and device products focused on infection control.
The AigisRx N antibacterial envelope is intended to hold a spinal cord neuromodulator or vagus nerve stimulator securely in order to provide a stable environment when implanted in the body. The envelope contains the antimicrobial agents rifampin and minocycline, which are released locally into the tissue.
“Surgical site infections are growing much faster than the underlying rate of surgical procedures, with patients often suffering catastrophic consequences,” stated Robert White, TYRX president and CEO. “Securing this expanded FDA clearance is another key milestone for TYRX in our quest to reduce surgical site infections where the clinical and economic consequences associated with infection are significant.”
TYRX makes implantable combination drug and device products focused on infection control.