The FDA has given New Jersey based TYRX, Inc. 510(k) clearance for its AIGISRx ST anti-bacterial patch for soft tissue repair. The material was previously FDA cleared for use in an envelope which reduces risk of infection following implantation of a pacemaker or cardioverter-defibrillator, and in its newly approved use it will help prevent post-operative infections in soft tissue.
From the product page:
AIGISRx is a dual component (resorbable and nonresorbable), sterile prosthesis constructed of open-pore weave, knotted filaments of a lightweight polypropylene mesh and coated with a resorbable polymer.
The resorbable polymer carries two distinct antibiotics: 1) minocycline and 2) rifampin. Minocycline acts as a bacteriostatic to inhibit protein synthesis while rifampin acts as a bactericidal that inhibits DNA-dependent RNA polymerase.
Press release: FDA Provides Clearance of TYRX Antibacterial Patch for Soft Tissue Repair…
Product page: AIGISRx…