PLC Systems’ REMEDIAL II investigator-sponsored clinical trial final results showed that RenalGuard was more effective than the current standard of care at preventing contrast-induced nephropathy (CIN) and dialysis in at-risk patients.
The trial is a randomized, multicenter clinical trial in Italy designed to provide an assessment of the potential benefits of induced diuresis with automated matched hydration therapy utilizing RenalGuard plus N-acetylcysteine, compared to N-acetylcysteine and a sodium bicarbonate solution in reducing the incidence of CIN in patients with baseline impairment in renal function.
The investigators found 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.
Notably the trial also found that RenalGuard Therapy significantly reduced the need for dialysis in high risk patients.
In the control group, 4.8% of these patients required some level of dialysis.
In contrast, only 0.7%, or 85% fewer, in the RenalGuard group required dialysis.
RenalGuard is approved for sale in the European Union as a general fluid balancing device.
PLC Systems president and CEO Mark Tauscher said the results of the REMEDIAL II clinical trial are consistent with findings from the MYTHOS trial presented in September 2010 at TCT, and provide additional scientific evidence that RenalGuard is safe and effective in combating CIN.