RenalGuard
RenalGuard Therapy®
A Therapeutic Approach to Reducing Contrast-Induced Nephropathy
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 kidneysRenalGuard
- 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 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. The RenalGuard System is not intended for infusion of blood, blood components, medications, or nutritional fluids. All treatments administered via The RenalGuard System must be prescribed by a physician. RenalGuard Solutions, Inc. reserves the right to modify the specifications and features described herein, or discontinue manufacture of the product described at any time without prior notice or obligation.
RenalGuard System™ is comprised of a Console and a RenalGuard Single Use Set for infusion and urine collection. The Single Use Set contains a urine collection set which connects to a patient’s Foley catheter and an infusion set which connects to a standard IV catheter. The Console measures the volume of urine in the collection set and infuses an equal volume of hydration fluid to match the patient’s urine output. The Console relies on proprietary, patented software and electronic weight measurements to control the rate at which fluid is infused and to monitor urine volume.
The Console is mounted on a custom IV pole and is equipped with an internal battery that allows operation while the patient is being transported within a hospital.
In addition to urine volume replacement, a user can set the RenalGuard System to achieve a net fluid gain over and above matched hydration or to achieve a net fluid loss. RenalGuard System allows infusion of a bolus of fluid at the user’s request. In addition, RenalGuard System is capable of adjusting matched hydration to take into account other fluid sources.
The 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.
RenalGuard- Hydration and High Urine Flow ED00035N
A Paradigm Shift in CI-AKI Prevention ED00092A
RenalGuard Studies
AKIGUARD__Acute_Kidney_Injury_GUARding_Device
Briguori Real World AHJ 2015
Chorin- Prevention of Post Procedural AKI 2016
MYTHOS- Prevention of Contrast Nephropathy by Furosemide with Matched Hydration–Marenzi
Nikolsky Eurointervention Editorial
PROTECT-TAVI
Putzu RenalGuard Meta-Analysis 2017
REMEDIAL II – Briguori – Circulation
Visconti RenalGuard and TAVI
