Press Release

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

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Posted 26 September 2008 @ 05:00 am ET

MONMOUTH JUNCTION, NJ -- (Marketwire) -- 09/26/08 -- TyRx, Inc., a leader in thedevelopment and commercialization of convergent drug-device medicalproducts, announced today the launch of AIGISRX(TM) ICD, an anti-bacterialenvelope developed to help stabilize the implanted device and which alsocontains anti-microbial agents that help provide protection againstsurgical site infections (SSI) associated with implantable cardioverterdefibrillators (ICDs).

The launch of AIGISRX ICD extends TyRx's AIGISRX CRMD (cardiac rhythmmanagement device) platform to the implantable cardioverter defibrillatormarket. The AIGISRX CRMD platform also includes AIGISRX PM, the Company'santi-bacterial coated mesh designed specifically for implanted pacemakers.TyRx received FDA 510(k) clearance of AIGISRX CRMD in January 2008. SinceMay 2008 the AIGISRX PM has been implanted in excess of 600 patientsnationwide.

During a CRMD implantation procedure, the physician inserts the pacemakeror ICD into the AIGISRX anti-bacterial envelope and positions the devicenormally within the surgically created pocket. Once implanted, AIGISRXprovides an adjunct to general antibiotic therapy by eluting theantimicrobial agents rifampin and minocycline and serves to stabilize theimplanted pacemaker or defibrillator.

"The launch of AIGISRX ICD offers a unique and potentially groundbreakingsolution for protecting an extremely vulnerable patient population, whileallowing hospitals to reduce the incidence and cost of treating surgicalsite infections related to ICD implantation," said Bill Edelman, CEO ofTyRx, Inc. With AIGISRX PM already in use at many of the top U.S. teachinghospitals, AIGISRX ICD further enables TyRx to take advantage of apotentially significant market opportunity as CMS looks to direct more ofthe cost and responsibility of hospital acquired infection to the medicalfacility. AIGISRX offers a solution which may meet the thresholds of highcost, high volume and reasonably preventable hospital-acquired conditionsthrough the application of evidence-based guidelines selection criteria setby CMS. In the August 19, 2008 Federal Registry, CMS stated, "we agree...that surgical site infection following certain cardiac device procedures isa strong HAC (hospital-acquired condition) candidate. The condition ishigh cost and high volume, triggers a higher-paying MS-DRG, and may beconsidered reasonably preventable through the application of evidence-basedguidelines... we expect to propose surgical site infection followingcertain cardiac device procedures... as future candidate HACs."

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

"The envelope provides antibiotic protection for about ten days after theprocedure. It also helps to stabilize the device in the body. The devicewill also make it easier for future device replacement," stated Dr. AliMassumi, Director of the Center for Cardiac Arrhythmias andElectrophysiology at St. Luke's and Clinical Professor of Medicine atHouston's Baylor College of Medicine. "These high risk patients are moreprone to infection. Obviously, we want to provide our patients with everyadvantage to prevent this complication." Dr. Massumi performed the firstin-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 andnon-resorbable -- anti-bacterial envelope designed to help reduce surgicalsite infections (SSI) and create a stable environment for implanted CRMDdevices. The AIGISRX CRMD technology is constructed of knitted filaments ofpolypropylene coated with a proprietary bioresorbable polymer that elutesthe antimicrobial agents rifampin and minocycline for a minimum of sevendays. In in vitro studies, AIGISRX CRMD has demonstrated antimicrobialactivity against Methicillin Resistant Staphylococcus aureus (MRSA),Staphylococcus aureus, Staphylococcus epidermidis, Acinetobacter baumanii,Enterobacter aerogenes and Proteus mirabilis, which represent a majority ofthe 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 devicemanufacturer, commercializes implantable combination drug-device productsutilizing novel biomaterials, including technology licensed exclusivelyfrom Rutgers, The State University of New Jersey. Additionally, TyRx hasexclusively licensed from Baylor College of Medicine and The University ofTexas M.D. Anderson Cancer Center product patents and associatedtechnologies to address the problem of postsurgical nosocomial infections.TyRx deploys capabilities across a broad range of combination implantabledrug-device therapies. The combination products sector (products combiningboth a drug and device component) is expected to be the highest growthsegment of the medical products industry with TyRx being positioned to bean innovative leader in this space.

More information may be found at www.TYRX.com.

CONTACTSBill EdelmanPresident and CEOTyRx, Inc.732.246.8676Email Contact


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