MONMOUTH JUNCTION, N.J.--()--TYRX, Inc. announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market AIGISRx® ST, its antibacterial product for the surgical repair of damaged or ruptured soft tissue.
“We were pleased that the FDA cleared this important new application”
TYRX had previously received 510(k) clearance to market a product for hernia repair and other abdominal soft tissue deficiencies. The new clearance adds the use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue. AIGISRx ST delivers the antimicrobial agents, rifampin and minocycline. These antimicrobial agents have been shown to reduce infections associated with medical devices in multiple randomized controlled trials.
“AIGISRx ST offers physicians a new tool to help address the relatively high rate of infection associated with a variety of soft tissue procedures,” remarked Rabih Darouiche, M.D., Director, Center for Prostheses Infection, Baylor College of Medicine. “Major infection rates of 3% to 4% are common and there is no accepted, locally acting means to help prevent these infections.”
AIGISRx ST extends the proprietary antibacterial technology developed by TYRX to gastrointestinal surgeons and general surgeons. AIGISRx ST has a resorbable polymer containing the antimicrobial agents rifampin and minocycline to help provide protection from microbial colonization. TYRX currently markets AIGISRx Envelope and AIGISRx FS which incorporate the same antibacterial technology and are cleared for use with the implantation of pacemakers and cardiac defibrillators. AIGISRx devices have been successfully implanted in over 9,000 patients in the United States.
“We were pleased that the FDA cleared this important new application,” said Robert White, TYRX CEO. “This is our first FDA cleared product outside of the cardiac rhythm management and hernia repair markets and we are now considering various commercialization strategies.”
About TYRX, Inc.
TYRX, Inc. commercializes innovative, implantable combination drug/device products focused on infection control including the AIGISRx® Antibacterial Envelope and the recently released AIGISRx® FS. AIGISRx products contain antimicrobial agents, rifampin and minocycline, which have been shown to reduce infection by organisms representing a majority of the infections reported in cardiac rhythm device (CRDM) related endocarditis, including "superbugs" or MRSA*.
Following commercial release in 2008, the AIGISRx Envelope has been implanted in over 9,000 patients nationwide. The company estimates that approximately 2% of all U.S. CRMD patients in 2010 will receive an AIGISRx product during their procedure.
TYRX, Inc. is an ISO 13485:2003 certified medical device manufacturer and its products utilize technology licensed exclusively from Rutgers, Baylor College of Medicine, and The University of Texas M. D. Anderson Cancer Center.
*Based upon preclinical in vitro and in vivo data. Data on file at TYRX and published in PACE 2009; 32(7) 898-907
For more information, please visit www.TYRX.com.