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."