Sam Brusco, Associate Editor01.24.23
CardioRenal Systems has been granted breakthrough status from the U.S. Food and Drug Administration (FDA) for its RenalGuard Therapy device to prevent acute kidney injury (AKI) in those at risk for cardiac surgery associated AKI (CSA-AKI).
AKI affects millions of patients worldwide, and in the estimated 780,000 cardiac surgeries performed annually in the U.S., Europe, and Middle East, AKI is reported in up to 30% of cases. Up to 80% of patients have pre-existing risk factors placing them at high risk. AKI complicates recovery, adds significant time to ICU hospitalization, and is one of the best predictors of in-hospital and long-term mortality following surgery.
RenalGuard aims to protect the kidneys using personalized, active hydration. This is done by maximizing urine output and balancing hydration using real-time urine output monitoring and IV infusion in a smart hydration system.
Ilya Budik, CardioRenal Systems' CEO told the press, "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 U.S. 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."
AKI affects millions of patients worldwide, and in the estimated 780,000 cardiac surgeries performed annually in the U.S., Europe, and Middle East, AKI is reported in up to 30% of cases. Up to 80% of patients have pre-existing risk factors placing them at high risk. AKI complicates recovery, adds significant time to ICU hospitalization, and is one of the best predictors of in-hospital and long-term mortality following surgery.
RenalGuard aims to protect the kidneys using personalized, active hydration. This is done by maximizing urine output and balancing hydration using real-time urine output monitoring and IV infusion in a smart hydration system.
Ilya Budik, CardioRenal Systems' CEO told the press, "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 U.S. 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."