REMEDIAL II Trial of PLC's RenalGuardÃ‚® Article Published in Circulation
MILFORD, Mass., Aug. 18, 2011 /PRNewswire/ -- PLC Systems Inc. (OTCBB: PLCSF), a company focused on innovative medical device technologies, today announced that final results from the REMEDIAL II investigator-sponsored clinical trial of RenalGuard® in Italy have been published on-line in Circulation, a peer-reviewed journal of the American Heart Association with a distribution of 23,900 worldwide, and will appear in the September 2011 issue of the publication. The results from this trial showed that RenalGuard is superior to the current standard of care at preventing Contrast-Induced Nephropathy (CIN) and in-hospital dialysis in high-risk patients undergoing certain imaging procedures.
In this trial, the investigators discovered that patients treated with RenalGuard and N-acetylcysteine (NAC) developed CIN, a serious and potentially fatal condition, at a much lower rate than patients in the control group who were treated with an infusion of sodium bicarbonate and NAC. Sodium bicarbonate plus NAC remains the current standard of care for the prevention of CIN in many healthcare institutions worldwide. The results provided strong scientific data that RenalGuard Therapy® is superior to sodium bicarbonate and N-acetylcysteine in preventing contrast-induced acute kidney injury (CI-AKI) in high-risk patients.
Mark R. Tauscher, President and Chief Executive Officer of PLC Systems, said, "The positive results of the REMEDIAL II clinical trial demonstrate with scientifically significant findings that RenalGuard is a superior approach to reducing the incidence of CIN in high-risk patients. This is another important proof point for RenalGuard and for PLC, and we're delighted that these results have been favorably evaluated by Circulation's advisory boar