FDA provides clearance of TyRx antibacterial patch for soft tissue repair
MONMOUTH JUNCTION, N.J., April 27, 2010 –(BUSINESS WIRE)– 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.
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.
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