CardioRenal Systems announced that the FDA granted Breakthrough Device Designation for its RenalGuard Therapy device for the prevention of Acute Kidney Injury (AKI) in patients at risk for Cardiac Surgery Associated AKI (CSA-AKI).
The FDA's Breakthrough Device Designation is a federally legislated program is designed to expedite the review process and to facilitate the clinical trial development of devices that treat life-threatening conditions or irreversibly debilitating human disease or conditions. The designation is awarded when a device's preliminary clinical data suggest it might be more effective than the current standard of care on clinically significant endpoints of efficacy, safety, or patient quality of life where no approved or cleared alternatives exist.
Acute Kidney Injury affects millions of patients worldwide undergoing common hospitalizations. In the estimated 780,000 cardiac surgeries performed each year in the US, Europe and the Middle East, AKI is reported in up to 30% of cases, and is the most common major surgical complication. As many as 80% of patients have pre-existing risk factors that place them at high risk. AKI complicates patient recovery, adds significant time to ICU hospitalization, and is one of the strongest predictors of in-hospital and long-term mortality after surgery.