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RenalGuard(TM) is an investigational system and therapy that targetspatients with compromised renal function who may be at risk for Contrast-Induced Nephropathy, or CIN, when undergoing cardiovascular imagingprocedures. RenalGuard Therapy(TM) is based on initial pre-clinical studydata that suggests that initiating and maintaining high urine output duringimaging procedures allows the body to rapidly eliminate toxins in contrastmedia, reducing their harmful effects. The RenalGuard System is a fully-automated, real-time matched fluid replacement device intended for the at-risksegment of the millions of interventional cardiology and radiology patientsundergoing these procedures.
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"We are very pleased to have the opportunity to introduce our innovativeRenalGuard System at TCT 2007 this year," stated Mark R. Tauscher, Presidentand CEO of PLC Systems Inc. "TCT is one of the most important meetings in thefield of Interventional Cardiology. They have been a leader in bringing theissues of CIN to the medical community. This will be an excellent opportunityfor us to meet with a large number of interventional cardiologists who arepotential investigators, and we are looking forward to the feedback we willreceive on RenalGuard Therapy and the RenalGuard System."
Earlier this year, the company announced the successful enrollment of thefirst patients in its FDA-approved pilot clinical trial designed to evaluatethe safety of its RenalGuard System. Safety results were favorable, and therewere no adverse renal events related to the device recorded.
Contrast-Induced Nephropathy
Approximately seven million patients worldwide undergo interventionalcardiovascular therapeutic and diagnostic imaging procedures each year. CIN isa major and growing problem due to the increasing number of older patients,diabetics and patients with pre-existing renal failure -- all of whoseconditions make them at risk for CIN when they require interventionalprocedures that use radiographic contrast media. CIN is the third most commoncause of in-hospital acute renal failure. It is associated with significantin-hospital mortality rates, and increases in long-term mortality rates, majorin-hospital adverse cardiac events, and the risk of having to undergo renaldialysis therapy. Any of these can result in prolonged hospital stays andincreased medical costs. Studies indicate that approximately 15-20% of allpatients undergoing image-guided cardiology and radiology procedures are atrisk of developing CIN. The estimated mortality rate for patients thatacquire 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 is currently conducting a pilot clinical safety study of itsRenalGuard Therapy and RenalGuard System. RenalGuard Therapy is designed toreduce the toxic effects that contrast media can have on the k
