Tyrx antibacterial patch
This article was originally published in The Gray Sheet
Executive Summary
Firm gains FDA 510(k) clearance of its AIGISRx ST antibacterial soft tissue patch, intended for surgical repair of damaged or ruptured soft tissue, Tyrx announces April 27. The product delivers the antimicrobial agents rifampin and minocycline to ward off infections while reinforcing soft tissue where weakness exists. Tyrx currently markets AIGISRx Envelope and AIGISRx FS, with the same antibacterial technology, for use with cardiac pacemaker and defibrillator implants. The firm began enrollment of the 2,300-patient CITADEL prospective multicenter trial of its AIGISRx antibacterial mesh envelope on March 24 (1"The Gray Sheet" April 5, 2010)