The U.S. FDA granted Breakthrough Device Designation for CardioRenal Systems 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 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 U.S., 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.

“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 US pivotal study,” says Ilya Budik, CardioRenal Systems’ CEO. “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.”

Photo: CardioRenal Systems