TYRX won 510(k) clearance from the FDA to expand marketing indications for its AIGISRx N antibacterial envelope to include use with spinal cord neuromodulators.
The Monmouth Junction, N.J.-based company may now market the device as a tool to help reduce surgical site infections associated with implantable devices for both neurology and cardiology.
The AIGISRx envelope is designed to hold a spinal cord neuromodulator or vagus nerve stimulator securely in place in order to provide a stable environment when implanted in the body, according to the press release.
“Surgical site infections are growing much faster than the underlying rate of surgical procedures, with patients often suffering catastrophic consequences," president and CEO Robert White said in prepared remarks. "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."