TyRx Pharma, Inc., a leader in the commercialization of implantable combination drug-device products, announced today the Food and Drug Administration (FDA) clearance of a Premarket 510(k) Application to market its AIGISRX™ CRMD Anti-Bacterial Envelope. Cardiac rhythm management device (CRMD) post-implant infection including cases of “super bug” or MRSA is a growing and potentially fatal complication.
AIGISRX™ CRMD has two functions. It is intended to securely hold a pacemaker or implantable cardioverter defibrillator (ICD) in order to create a stable environment when implanted in the body. In addition, AIGISRX™ CRMD contains the antimicrobial agents, rifampin and minocycline, which have been shown to reduce infection by organisms representing a majority of the infections reported in CRMD-related endocarditis, including MRSA. This device is only intended to be used in conjunction with pacemakers and ICDs.
AIGISRX™ CRMD is constructed of knitted filaments of polypropylene coated with a proprietary resorbable polymer that elutes the antimicrobial agents rifampin and minocycline for a minimum of 7 days to reduce the risk of infection of the implanted CRMD following surgery. In in vitro studies, AIGISRX™ CRMD demonstrated antimicrobial activity against Methicillin Resistant Staphylococcus aureus (MRSA), Staphylococcus aureus, Staphylococcus epidermidis, Acinetobacter baumanii, Enterobacter aerogenes, and Proteus mirabilis.
According to a recent study presented during the Heart Rhythm Society Heart Rhythm 2006 Scientific Sessions (Boston), the University of Pittsburgh Medical Center noted that the 2003 national incident of infection for pacemakers was estimated to be 5.82% and for ICDs 3.71%. Recent market research indicates that more than 400,000 CRMDs are implanted each year in the U.S.
“We are thrilled to have reached this value-creating milestone with the FDA clearance of AIGISRX™ CRMD,” said Bill Edelman, CEO of TyRx Pharma. “With over 400,000 annual U.S. implants of CRMDs, we believe AIGISRX™ CRMD will become a valuable tool in the effort to suppress bacterial infection of CRMD pockets.” Mr. Edelman continued, “We anticipate AIGISRX™ CRMD U.S. national commercial distribution to begin within the quarter following this FDA clearance, with full market release coinciding with the Heart Rhythm Society Heart Rhythm 2008, the premier conference on cardiac arrhythmias in San Francisco May 14-17, 2008.”
Rabih O. Darouiche, M.D., Director of the Center for Prostheses Infection at Baylor College of Medicine, Houston, Texas commented, "This first-in-class anti-infective approach is likely to yield tremendous benefit to both patients and clinicians taking into consideration the growing risk of infection and the severe consequences for those patients who may develop an infection."
According to Infection Control Today (8/2003), the average cost of each infection related to invasive medical devices varies from $34,000 to $56,000; these infections incur an annual financial burden up to $2.3 billion to the American healthcare system. The New England Journal of Medicine (New England Journal of Medicine, 2004;350:1422-9) states about half of the 2 million cases of nosocomial infection that occur each year in the United States are associated with indwelling devices. Infections associated with surgical implants are generally more difficult to manage because they require a longer period of antibiotic therapy and repeated surgical procedures.
Illustration: TyRx Pharma, Inc.
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TyRx Pharma, Inc.