REMEDIAL II Results on PLC System's RenalGuard® to be Presented at ACC 2011's Late Breaking Clinical Trial Session
FRANKLIN, Mass., April 1, 2011 /PRNewswire/ -- PLC Systems Inc. (OTCBB: PLCSF), a company focused on innovative medical device technologies, today reported that final results from the REMEDIAL II investigator-sponsored clinical trial of its RenalGuard System™ in Italy are scheduled to be presented at 11:57 a.m. CT on Monday, April 4, 2011, at the American College of Cardiology's (ACC) 60th Annual Scientific Session & Expo in New Orleans, Louisiana. Additionally, PLC will be demonstrating RenalGuard at its booth (#3932) at the conference.
Dr. Carlo Briguori, MD, PhD, Chief, Laboratory of Interventional Cardiology, Clinica Mediterranea, Naples, Italy, and Co-Director of Clinical Research, Laboratory of Interventional Cardiology, San Raffaele Hospital, Milan, Italy, the principal investigator for the REMEDIAL II trial, will present the results during a Late Breaking Clinical Trial session at the conference.
The REMEDIAL II trial is a randomized multi-center clinical trial in Italy designed to provide an assessment of the potential benefits of induced diuresis with automated matched hydration therapy utilizing RenalGuard, compared to a control group, in reducing the incidence of Contrast Induced Nephropathy (CIN) in patients with baseline impairment in renal function undergoing cardiac catheterization procedures and percutaneous coronary interventions.
RenalGuard is designed to reduce the potentially toxic effects that contrast media can have on the kidneys when it is administered to patients during certain medical imaging procedures. The RenalGuard System consists of a proprietary console and accompanying single-use sets. With its automated matched fluid replacement capability, RenalGuard is intended to promote and maintain high urine outputs and minimize the risk to patients of over- or under-hydration during image-guided catheterization procedures where contrast media are routinely administered.
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, Massachusetts, PLC today focuses on its newest product, RenalGuard, which is approved for sale in the EU as a general fluid balancing device. 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," "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 current clinical trials in Italy and the planned future U.S. clinical trial for RenalGuard may not be completed in a timely fashion, if at all, or, if these clinical trials are completed, they may not produce clinically significant or meaningful results, 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 the "Forward Looking Statements" section of our Annual Report on Form 10-K for the year ended December 31, 2010, a copy of which is filed with the SEC.
PLC Systems, PLC Medical Systems, PLC, RenalGuard and RenalGuard System are trademarks of PLC Systems Inc.
Contact: Mary T. Conway
SOURCE PLC Systems Inc.
Released April 1, 2011