FDA Clears TYRX Antibacterial Envelope For Use With Spinal Cord Neuromodulators
12/4/2013 6:38:26 AM
FDA Clears TYRX Antibacterial Envelope for Use with Spinal Cord Neuromodulators
MONMOUTH JUNCTION, N.J.--(BUSINESS WIRE)--TYRX, Inc. announced today that it has received U.S. Food and Drug Administration (FDA) clearance for expanded indications in marketing the AIGISRx® N Antibacterial Envelope for use with spinal cord neuromodulators. This comes after the recent FDA clearance of the AIGISRx N for use with vagus nerve stimulators. This expanded clearance extends TYRX’s 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.
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. Additionally, 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.”
About TYRX, Inc.
TYRX, Inc. commercializes innovative, implantable combination drug+device products focused on infection control, including the AIGISRx Antibacterial Envelope, designed to reduce surgical site infections associated with Cardiac Implantable Electronic Devices (CIEDs). AIGISRx products contain the antimicrobial agents, rifampin and minocycline, which have been shown to 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).*
For more information, please visit www.TYRX.com or www.HeartDeviceInfection.com.
*Data on file at TYRX and published Hansen et al. Pacing Clin Electrophysiol. 2009; 32(7):898-907.
Robert White, 732-246-8676
President and Chief Executive Officer
Joan Kureczka, 415-690-0210
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