The FDA has granted a Breakthrough Device Designation for RenalGuard Therapy®, an automated personal hydration device designed to prevent acute kidney injury (AKI) in patients undergoing cardiac surgery.
The RenalGuard device is designed to provide continuous diuresis and balanced rehydration. It measures real-time urine output and replenishes fluid via saline infusion.
AKI occurs in up to 30% of patients having cardiac surgery and predicts early death, according to a news release from CardioRenal Systems Inc., which makes RenalGuard. Risk factors include diabetes, anemia, chronic kidney disease, a cardiac surgery time longer than 120 minutes, and Log EuroScore higher than 5.
The FDA designation follows positive results from the KIDNEY Study published in the European Journal of Cardio-Thoracic Surgery in 2021. In the trial, investigators randomly assigned 220 patients undergoing cardiac surgery with cardiopulmonary bypass to RenalGuard Therapy or standard of care. Postoperative AKI rates were significantly lower with RenalGuard compared with a control group (10% vs 20.9%). The mean volumes of urine produced during surgery were higher with RenalGuard. To prevent 1 AKI episode, investigators estimated that 9 patients would need to be treated.
In the news release, Ilya Budik, the CEO of CardioRenal Systems, stated, “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.”
RenalGuard Therapy® receives FDA breakthrough device designation for prevention of cardiac surgery associated AKI. News release. CardioRenal Systems Inc.; January 20, 2023.
Luckraz H, Giri R, Wrigley B, et al. Reduction in acute kidney injury post cardiac surgery using balanced forced diuresis: a randomized, controlled trial. Eur J of Cardiothorac Surg. 2021;59(3):562-569. doi:10.1093/ejcts/ezaa395