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PLC Medical Systems Names Lead Investigators for Pivotal Trial to Evaluate RenalGuard System(TM) and RenalGuard Therapy(TM)
Date:12/19/2007

Guard Therapy is based on existing pre-clinical study data that suggests that initiating and maintaining high urine output during imaging procedures allows the body to rapidly eliminate toxins in contrast media, reducing their harmful effects. The RenalGuard System(TM) is a fully-automated, real-time matched fluid replacement device intended for interventional cardiology and radiology patients undergoing imaging procedures using contrast media.

PLC conducted a pilot study to confirm the safety of RenalGuard. Based upon the positive safety data collected in the pilot study and discussions with FDA, PLC stopped enrolling new patients in the pilot study and is preparing to submit a formal request to transition into a new pivotal trial protocol.

Contrast-Induced Nephropathy

Approximately seven million patients worldwide undergo interventional cardiovascular therapeutic and diagnostic imaging procedures each year. CIN is a major and growing problem due to the increasing number of older patients, diabetics and patients with pre-existing renal failure - all of whose conditions make them at risk for CIN when they require interventional procedures that use radiographic contrast media. CIN is the third most common cause of in-hospital acute renal failure. It is associated with significant in-hospital mortality rates, and increases in long-term mortality rates, major in-hospital adverse cardiac events, and the risk of having to undergo renal dialysis therapy. Any of these can result in prolonged hospital stays and increased medical costs. Studies indicate that approximately 15-20% of all patients undergoing image-guided cardiology and radiology procedures are at risk of developing CIN. The estimated mortality rate for patients that acquire CIN may be as high as 35%.

About PLC Systems Inc.

PLC Systems Inc. is a medical technology company specializing in innovative technologies for the cardiac and vascular markets. Headquartered in Franklin, Ma
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SOURCE PLC Systems Inc.
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