CardioRenal Systems has received the US Food and Drug Administration (FDA) Breakthrough Device Designation for its RenalGuard Therapy device to treat a type of kidney disease.
The device is indicated for the prevention of Acute Kidney Injury (AKI) in patients, who are at risk of developing Cardiac Surgery Associated AKI (CSA-AKI).
The US-based medical technology company said that its RenalGuard therapy is designed to protect the kidneys with personalised, active hydration.
It protects the kidneys by maximising the urine output, while balancing hydration through real-time urine output monitoring and IV infusion using a smart re-hydration system.
CardioRenal Systems CEO Ilya Budik said: “We are thrilled to receive the Breakthrough Device Designation and appreciate all the hard work that our team put in to get us here.
“We are looking forward to working closely with the FDA and our partners to facilitate the initiation of the upcoming US pivotal study.
“The high prevalence of AKI in cardiac surgery today is a well-known risk. We look forward to building further clinical validation that RenalGuard Therapy can provide the solution to reduce the prevalence of CSA-AKI, the length and cost of hospitalisation, and most importantly to improve patients’ quality of life.”
RenalGuard has significantly reduced the incidence of Contrast-Associated AKI, compared to the standard of care, in two investigator-sponsored studies, said the company.
The device comes with a console and a disposable RenalGuard set for infusion and urine collection.
The single-use set includes a urine collection kit, which connects to a patient’s Foley catheter, and an infusion set that connects to a standard IV catheter.
Its console of the device measures the volume of urine in the collection set and delivers an equal volume of hydration fluid through the infusion set.
The company said that the console works based on its patented software and electronic weight measurements to monitor urine volume, and control the fluid infusion rate.
