CardioRenal Systems’ RenalGuard Therapy Device Receives the US FDA’s Breakthrough Device Designation for Cardiac Surgery Associated AKI
- The US FDA has granted BTD to RenalGuard Therapy device for the prevention of acute kidney injury in patients with risk for CSA-AKI
- RenalGuard protects the kidneys with personalized, active hydration. The system maximizes urine output while balancing hydration through real-time urine output monitoring and IV infusions in a smart re-hydration system
- The (KIDNEY) study results from 220 patients demonstrated a 52% reduction in AKI over SoC, mean volumes of urine produced during surgery and within the first 24h postoperatively were higher in the RG system group, no differences in the incidence of blood transfusions, AF and infections and the median duration of intensive care unit stays were reported
Ref: PRNewswire | Image: RenalGuard Therapy
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