CardioRenal Systems has been awarded the US Food and Drug Administration (FDA) Breakthrough Device Designation, for its RenalGuard Therapy® device to address a specific form 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 purpose of the RenalGuard treatment is to protect the kidneys with individualized, active hydration.
Maximizing urine output while balancing hydration through real-time monitoring of urine output and IV infusion using a smart rehydration system protects the kidneys.
Millions of patients receiving routine hospital care are affected by acute kidney injury throughout the world. AKI is one of the most powerful predictors of in-hospital and long-term mortality after operation, complicating patient recovery and lengthening ICU hospitalization.