Healthcare Industry News: RenalGuard
News Release - March 16, 2007
First Patients Treated In RenalGuard(TM) Investigational Study By PLC Medical SystemsInitial study designed to test safety of RenalGuard System(TM) during Interventional Procedures
FRANKLIN, Mass., March 16 (HSMN NewsFeed) -- PLC Medical Systems, Inc. (Amex: PLC ), a company focused on innovative cardiac and vascular medical device-based technologies, announced the successful enrollment of the first patients in its FDA-approved clinical trial designed to evaluate the safety of its RenalGuard System(TM). Safety results were favorable, and there were no adverse renal events related to the device recorded. The RenalGuard System and RenalGuard Therapy(TM) are intended to reduce the incidence of Contrast- Induced Nephropathy (CIN) by managing real-time fluid balance and diuresis in conjunction with interventional procedures where contrast media are administered. The procedures, all done in conjunction with a percutaneous coronary intervention (PCI) employing multiple stents, were safely performed by Richard B. Zelman, M.D., at Cape Cod Hospital in Hyannis, Massachusetts.
"The use of RenalGuard Therapy maintained a high level of urine output, which is believed to reduce potential renal toxicity by protecting the kidney during interventional cardiac procedures requiring contrast media," said Dr. Zelman. "The system operated smoothly and did not change the flow of the catheterization procedure. The patients' procedures were completed successfully and the patients experienced no adverse renal complications."
"We are pleased by the positive, promising experience of our first patients to utilize the RenalGuard System and associated therapy," stated Mark R. Tauscher, President, PLC Medical Systems, Inc. "This first step gives us confidence that we will complete this pilot trial successfully."
Approximately seven million patients worldwide undergo interventional therapeutic and diagnostic procedures each year. Contrast-Induced Nephropathy (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, major in- hospital adverse cardiac events, and risk of 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%.
RenalGuard(TM) is an investigational system and therapy that targets patients with compromised renal function who may be at risk for CIN. RenalGuard Therapy is based on existing pre-clinical study data that support the theory that initiating and maintaining high urine output allows the body to rapidly eliminate contrast, reducing its toxic effects. RenalGuard is a fully-automated, real-time matched fluid replacement device intended for interventional cardiology and radiology patients undergoing imaging procedures using contrast media.
About PLC Systems Inc.
PLC Systems Inc. is a medical technology company specializing in innovative technologies for the cardiac and vascular markets. Headquartered in Franklin, Mass., 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 approved 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.
The company recently initiated clinical studies for its RenalGuard Therapy and RenalGuard System. RenalGuard's matched fluid replacement system is designed for interventional cardiology and radiology patients undergoing diagnostic and therapeutic imaging procedures where contrast agents are administered.
Additional company information can be found at 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," "estimates," "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 we may not receive necessary regulatory approvals to market our RenalGuard product, the clinical trials for that product may not be successful, 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 Report on Form 10-K for the year ended December 31, 2005, and our other SEC reports.
PLC Systems, PLC Medical Systems, PLC, CO2 Heart Laser, RenalGuard, RenalGuard System and RenalGuard Therapy are trademarks of PLC Systems Inc.
Source: PLC Medical Systems
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