TYRX, Inc. has received U.S. FDA clearance for expanded indications in marketing the AIGISRx® N Antibacterial Envelope for use with spinal cord neuromodulators. TYRX says this expanded clearance extends its leadership in the commercialization of implantable medical devices designed to help reduce Surgical Site Infections (SSIs) associated with implantable devices in the fields of neurosurgery and cardiology.
We’ve covered TYRX before, most recently back in April 2013 when we reported on the first implantation of its new AIGISRx R fully absorbable device envelope to protect against device-associated implant infection. The first implant was perfromed in Canada, with a first US procedure taking place in August following approval in May.
Unlike its fully absorbable young brother, AIGISRx N comprises a non-absorbable polypropylene mesh envelope. It is this older device that is the subject of the new expanded approval. Recently FDA cleared AIGISRx N for use with vagus nerve stimulators and now it has expanded indications again for the intended use of holding a spinal cord neuromodulator or vagus nerve stimulator securely in order to provide a stable environment when implanted in the body. The AIGISRx N 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 Chief Executive Officer. “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.”
Source: TYRX, Inc., Business Wire