TYRX has secured clearance from the US Food and Drug Administration (FDA) to sell its AIGISRx N, an antibacterial mesh envelope that can be used with spinal cord neuromodulators.
Approval for the expanded indication comes after the recent FDA clearance of the AIGISRx N for use with vagus nerve stimulators.
It has been designed to securely hold a spinal cord neuromodulator or vagus nerve stimulator in place in order to offer a stable environment when the device is implanted in the body.
AIGISRx N contains two antimicrobial agents rifampin and minocycline, which when released locally into the tissue, help reduce surgical site infections (SSIs).
These two antimicrobial agents reduce infection by pathogens responsible for the majority of CIED, spinal neuromodulator, and vagus nerve stimulator infections, including ‘superbugs’ such as methicillin-resistant S aureus (MRSA).
In July, the company received the FDA approval for use with vagus nerve stimulators used to treat seizure disorders and depression.
Tyrx president and CEO Robert White said surgical site infections are growing much faster than the underlying rate of surgical procedures, with patients often suffering 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 said.
The company has also received the FDA’s approval for a next-generation bioresorbable version of its envelope for use with a pacemaker and implantable cardioverter defibrillators (ICDs), while Health Canada, the Canadian regulatory agency granted approval in January this year.
According to GlobalData estimates, the US neurosurgical products market was valued at $59.7m in 2012 and is expected to grow at a CAGR of 3.4% to reach $75.2m by 2019.
Image: The AIGISRx N antibacterial envelope. Photo: courtesy of TYRX, Inc / Business Wire.