PLC Medical Systems to Demonstrate RenalGuard(TM) at EuroPCR 2008
RenalGuard(TM) is based on existing pre-clinical study data that suggeststhat initiating and maintaining high urine output during imaging proceduresallows the body to rapidly eliminate toxins in contrast media, reducing theirharmful effects. RenalGuard is a fully-automated, real-time matched fluidreplacement device intended for interventional cardiology and radiologypatients undergoing imaging procedures using contrast media.
"We are very pleased to have the opportunity to demonstrate our innovativeRenalGuard System at EuroPCR this year and increase awareness about what canbe done to mitigate the potentially harmful effects of contrast media oncompromised patients who require imaging procedures," stated Mark R. Tauscher,President and CEO of PLC Systems Inc. "We look forward to the feedback wewill receive on RenalGuard from the international medical community,especially the European market.
PLC received the CE Mark Certificate for the RenalGuard System in lateDecember 2007, and concluded its pilot safety trial in the U.S. late in 2007.The company has received conditional approval from the FDA to commence a U.S.pivotal trial to study the effectiveness of RenalGuard in the prevention ofCIN. In March 2008, PLC signed its first international distribution agreementfor RenalGuard with Artech s.r.l., Cavezzo, Italy for distribution of itsRenalGuard System into Italy.
Approximately seven million patients worldwide undergo interventionalcardiovascular therapeutic and diagnostic imaging procedures each year.Contrast-Induced Nephropathy, or CIN, is a major and growing problem due tothe increasing number of older patients, diabetics and patients with pre-existing renal failure - all of whose conditions make them at risk for CINwhen they require interventional procedures that use radiographic contrastmedia. CIN is the third most common cause of in-hospital acute renal failure.It is associated with significant in-hospital mortality rates, and increasesin long-term mortality rates, major in-hospital adverse cardiac events, andthe risk of having to undergo renal dialysis therapy. Any of these can resultin prolonged hospital stays and increased medical costs. Studies indicate thatapproximately 15-20% of all patients undergoing image-guided cardiology andradiology procedures are at risk of developing CIN. The estimated mortalityrate for patients that acquire CIN may be as high as 35%.
About PLC Systems Inc.
PLC Systems Inc. is a medical technology company specializing ininnovative technologies for the cardiac and vascular markets. Headquartered inFranklin, Mass., PLC pioneered the CO2 Heart Laser System, which cardiacsurgeons use to perform CO2 transmyocardial revascularization (TMR) toalleviate symptoms of severe angina. CO2 TMR offers a treatment option forangina patients who suffer from severe coronary artery disease. The CO2 HeartLaser is the world's first TMR angina relief device cleared for commercialdistribution by both the U.S. Food and Drug Administration and JapaneseMinistry of Health, Labor and Welfare, and to obtain a CE Mark for Europeandistribution.
The company completed a pilot clinical safety study of its RenalGuardTherapy(TM) and RenalGuard System and has received its CE Mark Certificate forRenalGuard System. PLC recently received FDA conditional approval to commencea U.S. pivotal trial to study the effectiveness of its RenalGuard Therapy an
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