PLC Systems Inc. (PLC), a medical technology company for cardiac and vascular markets, has published the initial abstract for the clinical study of its RenalGuard System sponsored by investigators. It has published the abstract on the ESC website, in advance of the annual meeting of the European Society of Cardiology, August 29 - September 2, 2009 in Barcelona, Spain.
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.
The CCM trial, known as MYTHOS, is a randomized clinical trial designed to provide an assessment of the potential benefits of induced diuresis with automated matched hydration therapy utilizing RenalGuard, compared to standard overnight hydration, a prevalent method of treatment in the EU, in the reducing the incidence of CIN in patients undergoing cardiac catheterization procedures and percutaneous coronary interventions with baseline impairment in renal function. The study is designed as a non-inferiority trial, with the primary endpoint defined as equivalency or better to overnight hydration.
The investigators for the trial are Dr. Antonio L. Bartorelli, Director, Interventional Cardiology, CCM, and Professor of Cardiology, University of Milan, and Dr. Marenzi, two of the world’s leading experts on CIN.
PLC received the CE Mark Certificate for the RenalGuard System in December 2007, and concluded its pilot safety trial in the US late in 2007. The company has received full approval from the FDA to commence a US pivotal trial to study the effectiveness of RenalGuard in reducing the incidence of CIN. In March 2008, PLC signed its first international distribution agreement for RenalGuard with Artech s.r.l., Cavezzo, Italy for distribution of its RenalGuard System into Italy, and in May 2009, PLC announced its second European distributor, IZASA Distribuciones Tecnicas S.A. , headquartered in Barcelona, Spain, for the distribution of RenalGuard in Spain.