RenalGuard’s Premarket Work in US

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RenalGuard Solutions (Milford, MA) said in 2017 that it expected a premarket approval filing for its fluid-management device in 2018, based on its contrast-induced nephropathy (CIN) study, CIN-RG, which is currently enrolling subjects.

The company’s investigational device, RenalGuard, protects patients from acute kidney injury (AKI), including contrast-induced AKI (CI-AKI). The system was designed to rapidly remove contrast dyes that can be toxic to kidneys.

Investigator-sponsored studies in Europe have demonstrated RenalGuard’s effectiveness at preventing CI-AKI in at-risk patients. RenalGuard measures a patient’s urine output and automatically infuses hydration fluid based on the level of urine output. The system is designed to induce high urinary excretion rates, which has been shown to protect kidneys.

RenalGuard is Conformite Europeene (CE)-marked and is sold in Europe and some other countries via a network of distributors.

Now the company has reported its first-in-humans feasibility study focused on a different use of the RenalGuard System: management of fluids during diuretic therapy in a group of congestive heart failure patients suffering from fluid overload. A recent study followed the treatment of 10 diuretic-resistant patients with heart failure symptoms receiving diuretic therapy while their fluid management was controlled by the RenalGuard System; results were presented at the annual Devices in Heart Failure (D-HF) congress in Berlin.

“None of the patients we treated experienced a fluid loss rate greater than the settings we established,” said Piotr Ponikowski, MD, of the Wroclaw Medical University, Poland, who also serves as chair of the European Society of Cardiology 2016 Heart Failure Guidelines Committee.

Other 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, and REMEDIAL II, which found RenalGuard superior to sodium bicarbonate hydration in preventing CI-AKI in high-risk patients. Meta-analyses of the study results have found RenalGuard reduced kidney injury, dialysis initiation, adverse events, and premature mortality compared to standard therapy, the company states.