Antibacterial Envelope Protects Cardiac Implants

A fully resorbable antibacterial envelope provides a safe environment for cardiac implantable electronic devices (CIEDs) until they are acclimated by the body.

The AIGISRx R antibacterial envelope is a bioresorbable mesh seeded with rifampin and minocycline antimicrobial agents that are slowly released into the tissue around the implant, reducing infection by the pathogens responsible for the majority of CIED infections, including methicillin-resistant Staphylococcus  aureus (MRSA). Studies have shown that in patients at high-risk for device infection, CIED implantation with an antibacterial envelope significantly reduced device infections by 70%–100%, compared to patients who did not receive one.

The bioresorbable mesh is created from naturally occurring substances and degrades in the presence of water. It can be easily manipulated, and is constructed of multiple hydrogen bonding sites that promote long-term drug elution and little or no "burst" effect. The degradation occurs in a relatively linear fashion, and as a result, has minimal acidity and is much less likely to promote inflammation and scarring. The AIGISRx R antibacterial envelope is a product of TYRX (Monmouth Junction, NJ, USA), and has been approved by the US Food and Drug Administration (FDA).

“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,” said Robert White, President and CEO of TYRX. “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.”

“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,” said electrophysiologist Prof. Charles Love, MD, of Ohio State University Medical Center (Columbus, OH, USA). “With more than 500,000 CIED implantations annually in the US, it is imperative that infections associated with these types of procedures are avoided to save lives and money.”

Minocycline and rifampin have been shown to provide a broad spectrum of activity against a wide range of antibiotic-sensitive and antibiotic-resistant bacteria, with the combination superior to vancomycin, clindamycin, novobiocin, and minocycline alone. In combination, they have also been found to be more potent than a combination of chlorhexidine and silver sulfadiazine, and equivalent to ceftazidime or amphotericin B against gram-negative bacilli and Candida albicans.

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