Trial designed to evaluate effectiveness of device in preventing
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-prevention therapy of induced diuresis and matched hydration therapy will be provided using RenalGuard.
"Contrast-Induced Nephropathy is a risky complication resulting from the use of contrast media for coronary and peripheral vascular diagnostic and interventional procedures in at-risk patients," stated Dr. Bartorelli. "Previous studies at our institution have demonstrated the benefit of hemofiltration in preventing CIN in patients with chronic renal failure. Our objective with this study is to assess the potential benefits of induced diuresis with matched hydration therapy compared to standard overnight hydration for the prevention of CIN."
Dr. Marenzi added, "CIN is a major life-threatening issue for at-risk patients undergoing imaging procedures since it can result in longer hospital stays and higher mortality rates. A cost-effective, easy-to-use preventive measure could save lives and reduce costs."
RenalGuard is based on existing 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 effect. RenalGuard is a fully-automated, real-time matched fluid replacement device intended for interventional cardiology and radiology patients undergoing imaging 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 and discussions with FDA, PLC stopped enrolling new patients in the pilot study and has received FDA conditional approval to commence a U.S. pivotal trial to study the effectiveness of its RenalGuard in the prevention of CIN.
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.
PLC's newest product program, RenalGuard (an investigational device in the U.S.), targets a costly and potentially deadly medical condition known as Contrast-Induced Nephropathy (CIN). Patients undergoing image-guided procedures, such as those performed when placing drug-eluting stents, can develop CIN because of the potentially toxic effects that contrast media used during these procedures can have on the kidneys. RenalGuard is based on the theory that creating and maintaining a high urine output is beneficial to patients undergoing imaging procedures where contrast agents are used. The company received its CE Mark Certificate for RenalGuard, and has received approval from the U.S. Food and Drug Administration to commence a U.S. pivotal trial to study the safety and effectiveness of RenalGuard in the prevention of CIN.
Headquartered in Franklin, Massachusetts, PLC pioneered the CO2 Heart Laser System, which cardiac surgeons use to perform CO2 transmyocardial revascularization (TMR) to alleviate symptoms of severe angina. CO2 TMR offers a treatment option for angina patients who suffer from severe coronary artery disease. The CO2 Heart Laser is the world's first TMR angina relief device cleared for commercial distribution by both the U.S. Food and Drug Administration and Japanese Ministry of Health, Labor and Welfare, and to obtain a CE Mark for European distribution.
Additional company information can be found at http://www.plcmed.com.
This press release contains "forward-looking" statements. For this purpose, any statements contained in this press release that relate to prospective events or developments are deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will" and similar expressions are intended to identify forward-looking statements. Our statements of our objectives are also forward-looking statements. While we may elect to update forward-looking statements in the future, we specifically disclaim any obligation to do so, even if our estimates change, and you should not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Actual results could differ materially from those indicated by such forward-looking statements as a result of a variety of important factors, including the CCM and other clinical trials for the RenalGuard product may not yield anticipated results, we may not receive necessary regulatory approvals to market our RenalGuard product, the RenalGuard product may not be commercially accepted, operational changes, competitive developments may affect the market for our products, regulatory approval requirements may affect the market for our products, and additional risk factors described in our Annual Report on Form 10-K for the year ended December 31, 2007, and our other SEC reports.
PLC Systems, PLC Medical Systems, PLC and CO2 Heart Laser, and
RenalGuard are trademarks of PLC Systems Inc.
Contact: Mary T. Conway
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