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PLC Medical Systems to Demonstrate RenalGuard(R) at ESC 2009
Date:8/31/2009

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The MYTHOS trial is a randomized clinical trial designed to provide an assessment of the potential benefits of induced diuresis with automated matched hydration therapy utilizing RenalGuard, compared to standard overnight hydration, a prevalent method of treatment in the EU, in reducing the incidence of CIN in patients undergoing cardiac catheterization procedures and percutaneous coronary interventions with baseline impairment in renal function. The study is designed as a non-inferiority trial, with the primary endpoint defined as equivalency or better to overnight hydration.

The investigators for the trial are Dr. Antonio L. Bartorelli, Director, Interventional Cardiology, CCM, and Professor of Cardiology, University of Milan, and Dr. Marenzi, two of the world's leading experts on CIN.

In the preliminary results presented at ESC, the trial had enrolled 90 chronic kidney disease (CKD) patients undergoing elective or urgent percutaneous coronary interventions (PCI). Approximately 14.9% of the patients in the control group were determined to have acquired CIN, whereas only 4.6% of those who were treated with RenalGuard acquired CIN. The MYTHOS trial anticipates enrolling a total of 120 patients, and is expected to be completed this year.

"Contrast-Induced Nephropathy is a serious complication resulting from the use of contrast media for coronary and peripheral vascular diagnostic and interventional procedures in high-risk patients," stated Dr. Bartorelli. "These preliminary results indicate that furosemide-induced high urine output with maintenance of intravascular volume through matched hydration can be safely obtained with the RenalGuard System and reduces the risk of CIN in these at-risk patients undergoing imaging procedures."

PLC received the CE Mark Certificate for the RenalGuard System in December 2007, and concluded its pilot safety trial in the U.S. late in 2007. The
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SOURCE PLC Systems Inc.
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