PLC Systems Inc. (OTC:PLCSF), a company focused on innovative cardiac and vascular medical device-based technologies, today announced that updated results from the MYTHOS investigator-sponsored clinical trial of RenalGuard in Italy showed that RenalGuard was more effective than the current standard of care at preventing Contrast Induced-Nephropathy (CIN). In scientifically significant results presented at Transcatheter Cardiovascular Therapeutics (TCT) 2010, the investigators found that patients treated with RenalGuard developed CIN, a serious and potentially fatal condition, at much lower rates than patients in the control group who were treated with overnight hydration, the current gold standard therapy.
Mark R. Tauscher, president and chief executive officer of PLC Systems, said, “We are extremely pleased that the latest updated results of the MYTHOS clinical trial corroborate earlier preliminary findings from this trial and provide scientific evidence that RenalGuard is more effective in combating CIN than overnight hydration. This is a pivotal point for PLC, one that we have awaited for several years, and we’re delighted that these results are being shared at TCT with a wide range of clinicians and potential partners. We look forward to additional presentations on RenalGuard, in hopes that these strong scientific findings will help us attract additional interest from distributors, partners and customers for our proprietary device.”
Dr. Antonio L. Bartorelli, Director, Interventional Cardiology, Centro Cardiologico Monzino-University of Milan (CCM), and Professor of Cardiology, University of Milan, one of the principal investigators for the MYTHOS trial, presented the results during a poster session at the conference.
The latest trial data presented is on 157 enrolled patients with chronic kidney disease (CKD) who underwent elective or urgent percutaneous coronary interventions (PCI) in Italy. The updated results indicate that patients who were at high risk for renal failure and who were treated with RenalGuard while undergoing certain imaging procedures developed CIN at a rate 69% lower than those who were treated beforehand with overnight hydration. Developing CIN has been found to lead to a range of serious and potentially deadly outcomes in patients who already have compromised kidney function. The trial also found that patients treated with RenalGuard had significantly fewer in-hospital adverse events than those treated with overnight hydration.
The principal investigators for this trial are Dr. Bartorelli and Dr. Giancarlo Marenzi, Chief, Intensive Cardiac Care Unit, CCM, two of the world’s leading experts on CIN prevention.
Dr. Bartorelli will also present the trial results in the “Featured Clinical Research” session, on September 24, 2010 at 6:15 PM.
The MYTHOS trial 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, in reducing the incidence of CIN in patients with baseline impairment in renal function undergoing cardiac catheterization procedures and percutaneous coronary interventions.
TCT, sponsored by the Cardiovascular Research Foundation, is being held September 21 – 25, 2010, in Washington, DC. PLC is demonstrating RenalGuard during the exhibits portion of the conference in booth 1005. More than 12,000 clinicians and professionals from around the world are expected to attend this event.
About PLC Systems Inc. (www.plcmed.com)
PLC Systems Inc. is a medical technology company specializing in innovative technologies for the cardiac and vascular markets. Headquartered in Franklin, Massachusetts, PLC pioneered the CO2 Heart Laser System, which cardiac surgeons use to perform CO2 transmyocardial revascularization (TMR) to alleviate symptoms of severe angina. PLC’s newest product, RenalGuard, is approved for sale in the EU as a general fluid balancing device.