CardioRenal Systems wins FDA breakthrough nod for RenalGuard Therapy device

[Image courtesy of CardioRenal Systems]CardioRenal Systems announced today that it received FDA breakthrough device designation for its RenalGuard Therapy device.

Milford, Massachusetts-based CardioRenal Systems designed the device for preventing acute kidney injury (AKI). It’s for patients at risk for cardiac surgery-associated AKI.

RenalGuard protects the kidneys with personalized, active hydration. The system maximizes urine output while balancing hydration. It does so through real-time urine output monitoring and IV infusion in a smart re-hydration system.

Results from the company’s KIDNEY study produced positive results for RenalGuard. CardioRenal Systems said the device demonstrated a 52% reduction in AKI compared to standard of care. The company evaluated it in a 220-patient, randomized, controlled clinical trial.

“We are thrilled to receive the breakthrough device designation and appreciate all the hard work that our team pu…

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