OVERVIEW
RenalGuard Therapy® is designed to reduce the incidence of Contrast-Induced Nephropathy (CIN) found in the millions of at-risk patients undergoing cardiovascular imaging procedures by managing real-time fluid balance in conjunction with interventional procedures involving contrast media.
HOW DOES IT WORK?
RenalGuard® is designed to rapidly remove contrast dyes that are known to be toxic to the kidneys. Contrast dyes are used in many cardiovascular diagnostic and interventional imaging procedures to facilitate the capture and display of x-ray images.
RenalGuard 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.
RenalGuard Therapy® measures a patient’s urine output and then infuses a volume of saline to maintain the desired fluid balance. It is a closed loop system designed to minimise the risk of over- or under-hydration whilst maintaining high urine rates, which have been shown to protect the kidney from a range of insults.
Approximately 10% to 20% of patients that undergo these procedures are at-risk of developing CIN, a form of acute kidney injury resulting from toxic contrast dye.
To date over 20,000 patients worldwide have been treated with RenalGuard.
RenalGuard® is CE-marked and is being sold in Europe and selected countries around the world.
1 Stevens, MA, McCullough, PA et al. A prospective randomized trial of prevention measures in patients at high risk for contrast nephropathy. JACC 1999;33:403-11
CLINICAL INVESTIGATIONS
A number of studies have demonstrated RenalGuard’s ability to protect patients from AKI following catheterization procedures when compared to the standard of care, including:
MYTHOS, which found RenalGuard to be superior to overnight hydration;
REMEDIAL II, which found RenalGuard to be superior to sodium bicarbonate hydration;
Protect-TAVI, which reported a significant reduction in post-procedural acute kidney injury (AKI) following transcatheter aortic valve replacement (TAVR) when using RenalGuard during the procedure, compared to standard therapy;
AKIGUARD, which showed significant improvement in long-term outcomes when using RenalGuard vs. standard therapy.
Two meta-analyses of these results (Putzu and Mattathil) found RenalGuard consistently reduced kidney injury, dialysis, adverse events and mortality compared to standard therapy.
