PLC Systems reports positive results of RenalGuard trial

15 January 2012 (Last Updated January 15th, 2012 18:30)

The Mythos investigator-sponsored clinical trial of PLC Systems' RenalGuard conducted in Italy has showed superiority in treating contrast-induced nephropathy (CIN) and in-hospital dialysis in at-risk patients undergoing certain imaging procedures.

The Mythos investigator-sponsored clinical trial of PLC Systems' RenalGuard conducted in Italy has showed superiority in treating contrast-induced nephropathy (CIN) and in-hospital dialysis in at-risk patients undergoing certain imaging procedures.

RenalGuard is a fully automated, real-time matched fluid replacement device intended for interventional cardiology and radiology patients undergoing imaging procedures using contrast media.

The Mythos trial is a randomised clinical trial designed to provide an assessment of the potential benefits of induced diuresis with automated matched hydration therapy using the RenalGuard device. It was conducted on 170 patients with chronic kidney disease (CKD) who underwent elective or urgent percutaneous coronary interventions (PCI), indicated that patients who were at higher risk for renal failure and who were treated with RenalGuard while undergoing imaging procedures developed CIN at a rate 74% lower than those who were treated with overnight hydration. The study also demonstrated that patients treated with RenalGuard had considerably fewer in-hospital adverse events than those treated with overnight hydration.

PLC Systems president and CEO Mark Tauscher said the top-line results of the Mythos clinical trial demonstrated that RenalGuard was a superior approach to reduce the incidence of CIN in at-risk patients. ''The results of this trial were the first important proof point for RenalGuard and for PLC, and we're delighted that these results are now being shared with practitioners and potential partners from around the world. We believe that greater awareness of these positive scientific findings and the positive findings from the REMEDIAL II trial will further drive the interest we are seeing from distributors, partners and customers for RenalGuard in the markets where it is available."

The final results from the Mythos trial were published in the January 2012 issue of JACC - Cardiovascular Interventions, while the initial results from the study were first presented at Transcatheter Cardiovascular Therapeutics (TCT) in September 2010.

The previous two investigator-sponsored European studies demonstrated RenalGuard's effectiveness at preventing CIN, and currently RenalGuard is being studied in a pivotal trial in the US.