PLC Systems Inc. (OTC Bulletin Board: PLCSF), a company focused on innovative cardiac and vascular medical device-based technologies, today announced that the initial abstract for the investigator-sponsored clinical study of its RenalGuard System(TM) has been published, in advance of the annual meeting of the European Society of Cardiology, August 29 - September 2, 2009 in Barcelona, Spain, on the ESC website.
More comprehensive data are expected to be presented by one of the study's investigators, Dr. Giancarlo Marenzi, Chief, Intensive Cardiac Care Unit, Centro Cardiologico Monzino-University of Milan (CCM) in his session next week during the conference, at which PLC will also be demonstrating RenalGuard((R)).
The abstract details data on 43 patients at high risk for renal failure; the final study will include 120 such patients. The initial results indicate that none of the patients treated with RenalGuard( )while undergoing imaging procedures acquired contrast-induced nephropathy (CIN), but 17% of those who were treated beforehand with overnight hydration did acquire CIN. In fact, two of the patients in that group required temporary renal replacement therapy. Acquiring CIN has been found to lead to a range of serious and potentially deadly outcomes in patients who already have compromised kidney function.
Mark R. Tauscher, president and chief executive officer of PLC Systems, said, "We are extremely pleased with these very positive preliminary results of the CCM clinical trial. These initial results provide encouraging evidence that RenalGuard is highly effective in reducing the incidence of CIN, in millions of high-risk patients around the world every year. While we anticipate that later results may reflect higher rates of CIN with RenalGuard, we are very encouraged by the dramatic benefit already demonstrated by the initial results of the study."