The FDA granted 510(k) to New Jersey-based TYRX for its next-generation AIGISRx R Antibacterial Envelope, indicated to address high infection rates after pacemaker and implantable cardioverter defibrillator implantation surgeries.
The newly cleared AIGISRx R is a fully resorbable version of the company’s line of antibacterial envelopes. TYRX touted study data demonstrating that the device reduces infection rates by more than 50%.
The drug-device combo maker, based in Monmouth Junction, N.J., develops products to combat hospital infections, including the growing problem of super-resistant bugs like MRSA.
"Without question, FDA-clearance is a major milestone for TYRX and cements our leadership in the effort to reduce surgical site infections following CIED implantation," said CEO Robert White in prepared remarks. "Our mission is to make the AIGISRx R a standard-of-care for all high-risk CIED surgeries where patients are especially vulnerable to the dire effects of an infection."