TYRX, Inc. (Monmouth Junction, NJ) won FDA clearance for its fully resorbable AIGISRx R antibacterial envelope that’s used for implanting cardiac devices and providing a safe space for the implants to be acclimated by the body.
The device, that’s made from a bioresorbable mesh, is seeded with rifampin and minocycline antimicrobial agents that are slowly released into the tissue around the implant. This is essentially the same device as the previously covered AIGISRx, except with the major improvement of being resorbable.
From the announcement:
“Over the last couple of decades, the number of cardiac device infections has risen sharply and out of proportion to the number of device implantations. With more than 500,000 CIED implantations annually in the U.S., it is imperative that infections associated with these types of procedures are avoided to save lives and money,” according to electrophysiologist Dr. Charles Love, Professor of Medicine and the Director of Cardiac Rhythm Device Services for the Division of Cardiovascular Medicine at The Ohio State University Wexner Medical Center. “The AIGISRx R provides physicians with a key technology to prevent surgical site infections following CIED implantation.”
“The AIGISRx R represents the next generation of TYRX’s Antibacterial Envelope technology, providing all of the advantages of the original AIGISRx, such as device stabilization and infection reduction, but now with the added benefit of being fully resorbable,” commented Robert White, TYRX President and Chief Executive Officer. “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. 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.”