TyRx Launches AIGISRX(TM) ICD To Reduce Surgical Site Infections Associated With Implantable Cardioverter Defibrillators

Main Category: MRSA / Drug Resistance
Also Included In: Medical Devices / Diagnostics;  Cardiovascular / Cardiology;  Infectious Diseases / Bacteria / Viruses
Article Date: 26 Sep 2008 - 4:00 PDT

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TyRx, Inc., a leader in the development and commercialization of convergent drug-device medical products, announced today the launch of AIGISRX(TM) ICD, an anti-bacterial envelope developed to help stabilize the implanted device and which also contains anti-microbial agents that help provide protection against surgical site infections (SSI) associated with 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. TyRx received FDA 510(k) clearance of AIGISRX CRMD in January 2008. Since May 2008 the AIGISRX PM has been implanted in excess of 600 patients nationwide.

During a 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 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 launch of AIGISRX ICD offers a unique and potentially groundbreaking solution for protecting an extremely vulnerable patient population, while allowing hospitals to reduce the incidence and cost of treating surgical site infections related to ICD implantation," said Bill Edelman, CEO of TyRx, Inc. With AIGISRX PM already in use at many of the top U.S. teaching hospitals, AIGISRX ICD further enables TyRx to take advantage of a potentially significant market opportunity as CMS looks to direct more of the cost and responsibility of hospital acquired infection to the medical facility. AIGISRX offers a solution which may meet the thresholds of high cost, high volume and reasonably preventable hospital-acquired conditions through the application of evidence-based guidelines selection criteria set by CMS. In the August 19, 2008 Federal Registry, CMS stated, "we agree... that surgical site infection following certain cardiac device procedures is a strong HAC (hospital-acquired condition) candidate. The condition is high cost and high volume, triggers a higher-paying MS-DRG, and may be considered reasonably preventable through the application of evidence-based guidelines... we expect to propose surgical site infection following certain cardiac device procedures... as future candidate HACs."

The Center for Disease Control and Prevention (CDC) estimates that approximately two million patients contract nosocomial infections annually with 50% being associated with indwelling devices. In testimony before Congress, The Leap Frog Group pointed to the fact that "hospital acquired infections (HAI) add over $15,000 to a patient's hospital bill, amounting to over $30 billion a year wasted on avoidable costs."

"The envelope provides antibiotic protection for about ten 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 Dr. Ali Massumi, 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." Dr. Massumi performed the first in-man procedure using AIGISRX PM on May 12, 2008.

About AIGISRX(TM) CRMD

AIGISRX(TM) CRMD, FDA 510(k) cleared, is a dual-component -- resorbable and non-resorbable -- anti-bacterial envelope designed to help reduce surgical site infections (SSI) and create a stable environment for implanted CRMD devices. 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.

About TyRx, Inc.

TyRx, Inc., an IS0 9001:2000 and IS0 13485:2003 certified medical device manufacturer, commercializes implantable combination drug-device products utilizing novel biomaterials, including technology licensed exclusively from Rutgers, The State University of New Jersey. Additionally, TyRx has exclusively licensed from Baylor College of Medicine and The University of Texas M.D. Anderson Cancer Center product patents and associated technologies to address the problem of postsurgical nosocomial infections. TyRx deploys capabilities across a broad range of combination implantable drug-device therapies. The combination products sector (products combining both a drug and device component) is expected to be the highest growth segment of the medical products industry with TyRx being positioned to be an innovative leader in this space.

TyRx, Inc.