News | September 28, 2008

Anti-bacterial Envelope Reduces Surgical Site Infections Associated With ICDs

September 26, 2008 - TyRx Inc. announced today the launch of AIGISRX ICD, an anti-bacterial envelope developed to help reduce surgical site infections and create a stable environment for implantable cardioverter defibrillators (ICDs).

The launch of AIGISRX ICD extends TyRx's AIGISRX CRMD (cardiac rhythm management device) platform to the implantable cardioverter defibrillator market. The AIGISRX CRMD platform also includes AIGISRX PM, the Company's anti-bacterial coated mesh designed specifically for implanted pacemakers.

FDA-cleared in January 2008, the AIGISRX CRMD technology is constructed of knitted filaments of polypropylene coated with a proprietary bioresorbable polymer that elutes the antimicrobial agents rifampin and minocycline for a minimum of seven days. In in- vitro studies, AIGISRX CRMD has demonstrated antimicrobial activity against Methicillin resistant Staphylococcus aureus (MRSA), Staphylococcus aureus, Staphylococcus epidermidis, Acinetobacter baumanii, Enterobacter aerogenes and Proteus mirabilis, which represent a majority of the infections reported in CRMD related endocarditis, including "superbugs" or MRSA.

During a cardiac rhythm management device (CRMD) implantation procedure, the physician inserts the pacemaker or ICD into the AIGISRX anti-bacterial envelope and positions the device normally within the surgically created pocket. Once implanted, AIGISRX reportedly provides an adjunct to general antibiotic therapy by eluting the antimicrobial agents, rifampin and minocycline, and serves to stabilize the implanted pacemaker or defibrillator.

"The envelope provides antibiotic protection for about 10 days after the procedure. It also helps to stabilize the device in the body. The device will also make it easier for future device replacement," stated Ali Massumi, M.D., director of the Center for Cardiac Arrhythmias and Electrophysiology at St. Luke's and clinical professor of medicine at Houston's Baylor College of Medicine. "These high-risk patients are more prone to infection. Obviously, we want to provide our patients with every advantage to prevent this complication."

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