FRANKLIN, Mass., March 20 /PRNewswire-FirstCall/ -- PLC Systems Inc. (Amex: PLC) announced today that it has received conditional approval from the U.S. Food and Drug Administration (FDA) to begin enrollment in a U.S. pivotal trial to study the effectiveness of the Company's RenalGuard Therapy(TM) and RenalGuard System(TM) in the prevention of Contrast-Induced Nephropathy (CIN).
Mark R. Tauscher, President and Chief Executive Officer of PLC, said, "We are very pleased with the FDA's conditional approval to the Investigational Device Exemption (IDE) supplement we filed last month. This will enable us to commence our pivotal study on schedule this spring. We are focused now on incorporating FDA's input into our final study protocol, and rapidly moving through the next phase of our clinical trial plan, which includes securing approvals to begin our study from hospital Institutional Review Boards at the sites that have elected to participate. FDA approval of the IDE is another major milestone on our path forward to commercializing the RenalGuard therapy and system, and we are very excited about beginning the pivotal trial."
Contrast-Induced Nephropathy, or CIN, is a major and growing problem due to the increasing number of older patients, diabetics and patients with pre- existing renal impairment - all of whose conditions make them at risk for CIN when they require interventional procedures that use radiographic contrast media. The Company's U.S. pivotal study, under the supervision of principal investigators Charles Davidson, MD, Professor of Medicine, Northwestern University Medical School and Richard J. Solomon, MD, Professor of Medicine, University of Vermont College of Medicine, is designed as an adaptive, randomized controlled trial at up to 30 sites in the U.S. Enrollment in the trial is expected to last through 2009, and will include a minimum of 246 patients.
Approximately seven million patients worldwide undergo interventional cardiovascular therapeutic and diagnostic imaging procedures each year. 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%.
RenalGuard is based on existing pre-clinical 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 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 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.
The company concluded a pilot clinical safety study of its RenalGuard Therapy and RenalGuard System in December 2007. In late 2007, the company received its CE Mark Certificate for RenalGuard System. RenalGuard Therapy is designed to reduce the toxic effects that contrast media can have on the kidneys. This therapy 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 real-time measurement and matched fluid replacement design of the RenalGuard System is intended to ensure that a high urine flow is maintained before, during and after these procedures. This should allow the body to rapidly eliminate contrast, reducing its toxic effects. The RenalGuard System, with its matched fluid replacement capability, is intended to minimize the risk of over- or under-hydration.
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 that we may not receive necessary regulatory approvals to market our RenalGuard product or that such approvals may be withdrawn, 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-Q for the quarter ended September 30, 2007, and our other SEC reports.
PLC Systems, PLC Medical Systems, PLC and CO2 Heart Laser, RenalGuard,
RenalGuard Therapy and RenalGuard System are trademarks of PLC Systems Inc.
Contact: Mary T. Conway
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