New AIGISRx Flat provides antimicrobial protection from CRMD infection

Apr 15 2010

TYRX, Inc. announced today the commercial release of the AIGISRx™ Flat, an antibacterial product that helps provide protection against infections associated with implanted pacemakers and defibrillators.

“We anticipate the AIGISRx products will be adopted as the standard during CRMD implants procedures”

Like the original AIGISRx™ Envelope, AIGISRx Flat delivers the anti-microbial agents, rifampin and minocycline which have been shown to reduce infection by organisms representing a majority of the infections reported in cardiac rhythm management device (CRMD)-related endocarditis, including "superbugs" or MRSA. AIGISRx Flat also offers the implanting physician additional flexibility in the application of these lifesaving devices.

"The current AIGISRx envelope provides potent antimicrobial protection and also anchors the device to prevent device migration. However, in patients who are undergoing battery change-outs, using the AIGISRx Flat option helps minimize dissection of the pre-existing pocket," notes Heather Bloom, MD, Assistant Professor of Medicine, Emory University School of Medicine, Director, Cardiac Electrophysiology Services, Atlanta VA Medical Center. "Since the risk of infection is much higher in change-outs, partially due to the avascular pocket preventing tissue penetration by oral antibiotics, having a drug-eluting device on the site is of critical importance."

Hospitalization for CRMD infection increased faster than rates of CRMD implants from 1996 through 2006, according to the National Hospital Discharge Survey, conducted by the Centers for Disease Control and Prevention. The disproportionate rise in CRMD-related infections carries significant public health consequences. This was further reinforced in the January 2010 guideline issued by the American Heart Association and Heart Rhythm Society which explicitly states there is a significant unmet clinical need in CRMD related infection.

Over 5 million people worldwide currently have a pacemaker or defibrillator with 500,000 people receiving a pacemaker or defibrillator each year in the United States.

Following commercial release in 2008, AIGISRx has been implanted in over 8,500 patients nationwide. The company estimates that approximately 1% of all U.S. CRMD patients in 2010 will receive an AIGISRx envelope during their procedure.

"We anticipate the AIGISRx products will be adopted as the standard during CRMD implants procedures," remarked Robert White, TYRX CEO. "One of the great strengths of TYRX is the ability to leverage our current anti-bacterial technology into a wide variety of clinical applications. We are eager to help physicians and hospitals continue to address the significant unmet needs in infection control."