PLC Systems Announces Approval of First European Study to Evaluate Rena...( Trial designed to evaluate effe...),Health

Trial designed to evaluate effectiveness of device in preventing

Contrast-Induced Nephropathy

FRANKLIN, Mass., May 30 /PRNewswire-FirstCall/ -- PLC Systems Inc. (Amex: PLC), a company focused on innovative cardiac and vascular medical device-based technologies, announced today that the ethics committee of the Centro Cardiologico Monzino (CCM-University of Milan), Milan, Italy has approved the planned randomized clinical trial to evaluate the use of RenalGuard(TM) in the prevention of Contrast-Induced Nephropathy (CIN) in high-risk patients undergoing catheterization procedures at its institution.

The investigators for the trial are Dr. Antonio L. Bartorelli, Director, Interventional Cardiology, CCM, and Professor of Cardiology, University of Milan, and Dr. Giancarlo Marenzi, Chief, Intensive Cardiac Care Unit, CCM, who are two of the world's leading experts in the prevention of CIN.

PLC's President and Chief Executive Officer, Mark R. Tauscher, said, "We are very pleased that this study has received approval from CCM's ethics committee. We anticipate that this study will greatly increase the visibility of our RenalGuard System in Europe, and that the data gathered from the study will enable us to seek expanded claims in order to market RenalGuard as a CIN prevention device throughout the European Union."

The trial is designed as a prospective, open, randomized trial to provide an assessment of the potential benefits of induced diuresis with matched hydration therapy, compared to standard overnight hydration, in the prevention of CIN in patients undergoing cardiac catheterization procedures and percutaneous coronary interventions with baseline impairment in renal function. The CIN-prev
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