US-based TYRX has obtained an approval from the US Food and Drug Administration (FDA) for expanded indications in marketing the AIGISRx N antibacterial envelope for use with spinal cord neuromodulators.
Recently, TYRX has also obtained an approval from the FDA for AIGISRx N antibacterial envelope for use with vagus nerve stimulators.
TYRX’s AIGISRx N antibacterial envelope is designed to hold a spinal cord neuromodulator or vagus nerve stimulator securely in order to provide a stable environment when implanted in the body.
TYRX president and CEO Robert White noted surgical site infections are growing much faster than the underlying rate of surgical procedures, with patients often suffering catastrophic consequences.
"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," White added.
AIGISRx products contain the antimicrobial agents, rifampin and minocycline, which have been shown to reduce infection by pathogens responsible for the majority of cardiovascular implantable electronic device, spinal neuromodulator, and vagus nerve stimulator infections, including ‘superbugs’ such as methicillin-resistant S. aureus.
Image: TYRX’s AIGISRx N antibacterial envelope gets FDA approval. Photo: Courtesy of BusinessWire.