PLC Systems Announces Approval of First European Study to Evaluate RenalGuard(TM)

FRANKLIN, Mass., May 30 PLC Systems Inc.(Amex: PLC), a company focused on innovative cardiac and vascular medicaldevice-based technologies, announced today that the ethics committee of theCentro Cardiologico Monzino (CCM-University of Milan), Milan, Italy hasapproved the planned randomized clinical trial to evaluate the use ofRenalGuard(TM) in the prevention of Contrast-Induced Nephropathy (CIN) inhigh-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 ofMilan, and Dr. Giancarlo Marenzi, Chief, Intensive Cardiac Care Unit, CCM, whoare two of the world's leading experts in the prevention of CIN.

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

The trial is designed as a prospective, open, randomized trial to providean assessment of the potential benefits of induced diuresis with matchedhydration therapy, compared to standard overnight hydration, in the preventionof CIN in patients undergoing cardiac catheterization procedures andpercutaneous coronary interventions with baseline impairment in renalfunction. The CIN-prevention therapy of induced diuresis and matchedhydration therapy will be provided using RenalGuard.

"Contrast-Induced Nephropathy is a risky complication resulting from theuse of contrast media for coronary and peripheral vascular diagnostic andinterventional procedures in at-risk patients," stated Dr. Bartorelli."Previous studies at our institution have demonstrated the benefit ofhemofiltration in preventing CIN in patients with chronic renal failure. Ourobjective with this study is to assess the potential benefits of induceddiuresis with matched hydration therapy compared to standard overnighthydration for the prevention of CIN."

Dr. Marenzi added, "CIN is a major life-threatening issue for at-riskpatients undergoing imaging procedures since it can result in longer hospitalstays and higher mortality rates. A cost-effective, easy-to-use preventivemeasure could save lives and reduce costs."

RenalGuard is based on existing study data that suggests that initiatingand maintaining high urine output during imaging procedures allows the body torapidly eliminate toxins in contrast media, reducing their harmful effect.RenalGuard is a fully-automated, real-time matched fluid replacement deviceintended for interventional cardiology and radiology patients undergoingimaging procedures using contrast media.

In the U.S., PLC recently completed a pilot safety study of RenalGuard.Based upon the positive safety data collected in the pilot study anddiscussions with FDA, PLC stopped enrolling new patients in the pilot studyand has received FDA conditional approval to commence a U.S. pivotal trial tostudy the effectiveness of its RenalGuard in the prevention of CIN.

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 ra