News | September 30, 2009

RenalGuard Contrast-Induced Nephropathy Device Shows Positive Interim Results in MYTHOS Trial

September 30, 2009 – PLC Systems Inc. demonstrated its RenalGuard System to help prevent contrast-induced nephropathy (CIN) and presented data from its MYTHOS Clinical Trial at the Transcatheter Cardiovascular Therapeutics (TCT) 2009 symposium last week in San Francisco.

Dr. Giancarlo Marenzi, chief, intensive cardiac care unit, Centro Cardiologico Monzino-University of Milan (CCM), presented interim results of the MYTHOS investigator-sponsored clinical trial of RenalGuard for the first time in the United States. These results were first presented at ESC 2009, the annual meeting of the European Society of Cardiology, in late August in Barcelona, Spain.

The trial enrolled 90 chronic kidney disease (CKD) patients undergoing elective or urgent percutaneous coronary interventions (PCI). Approximately 14.9 percent of the patients in the control group were determined to have acquired contrast-induced nephropathy (CIN), whereas only 4.6 percent 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. More information about the trial is available at the company's Web site www.plcmed.com/Products-Clinical-Investigations2.asp.

The MYTHOS data indicates that patients who were at high risk for renal failure, treated with RenalGuard while undergoing certain imaging procedures, acquired CIN at a significantly lower rate than those who were treated beforehand with overnight hydration. Acquiring CIN has been found to lead to a range of serious and potentially deadly outcomes in patients who already have compromised kidney function.

The investigators for the trial are Dr. Antonio L. Bartorelli, director, interventional cardiology, CCM, and professor of cardiology, University of Milan, and Dr. Marenzi, both leading experts on CIN.

Dr. Bartorelli and Dr. Marenzi participated in a “Hot Topics” lunch session Sept. 25, entitled “Chronic Kidney Disease and Contrast Nephropathy: Implications for the PCI Patient.” Dr. Marenzi also presented “RenalGuard: A New Hydration Method,” the first clinical presentation of the MYTHOS study in the United States.

"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.”

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, in reducing the incidence of CIN in patients with baseline impairment in renal function undergoing cardiac catheterization procedures and percutaneous coronary interventions.

The RenalGuard, is approved for sale in the EU as a general fluid balancing device. PLC received the CE mark for the RenalGuard System in December 2007. The company has received approval from the FDA to commence a U.S. pivotal trial to study the effectiveness of RenalGuard in reducing the incidence of CIN.

For more information: www.plcmed.com

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