RenalGuard Therapy® is designed to reduce the toxic effects that contrast media can have on the kidneys, which may lead to a reduction in the incidence of Contrast-Induced Nephropathy (CIN) in at-risk patients. This therapy is based on existing published literature, including the PRINCE study1, which support the theory that creating and maintaining a high urine output through the kidneys allows the body to rapidly eliminate contrast, reducing its toxic effects.
High urine rates may reduce the incidence of Contrast-Induced Nephropathy via a combination of known physiological factors, including:
More rapid transit of contrast through the kidneys
Less overall exposure to toxic contrast
Reduced oxygen consumption in the medulla of the kidney
RenalGuard Therapy entails the use of a physician-prescribed loop diuretic which may induce the required high urine output. RenalGuard System is designed to measure urine output and replaces it in real-time with an equal volume of sterile saline. This matched fluid replacement aims to minimize the risk of over- or under-hydration which can lead to increased patient risks.
RenalGuard has been shown in two investigator sponsored studies to significantly reduce the incidence of CIN when compared to the standard of care.
RenalGuard System is CE-marked for the intended use of temporary (up to 14 days) replacement of urine output by infusion of a matched volume of sterile replacement solution to maintain a patient’s intravascular fluid volume, and has demonstrated accurate matched replacement and an appropriate safety profile with normal saline in limited human use.
Caution - INVESTIGATIONAL DEVICE, LIMITED BY UNITED STATES LAW TO INVESTIGATIONAL USE.
Product URL : http://www.plcmed.com/renalguard
Last Updated : 09/13/2013