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 put in to get us here,” said CardioRenal Systems CEO Ilya Budik. “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 hospitalization, and most importantly to improve patients’ quality of life.”