FDA awards CardioRenal Systems Breakthrough Device Designation for RenalGuard Therapy

pharmafile | January 23, 2023 | News story | Medical Communications  

The FDA has granted Breakthrough Device Designation for US-based medical technology company CardioRenal for their RenalGuard Therapy device, used to treat a kind of kidney disease.

 

RenalGuard Therapy is used to prevent acute kidney injury (AKI) in patients who are at risk of developing cardiac surgery associated AKI (CSA-AKI). It works by maximising urine output while balancing hydration, utilising real-time urine output monitoring and IV infusion using a re-hydration system.

 

The device comes with a console and a disposable RenalGuard set for infusion and urine collection. It is a single-use set including a urine collection kit which connects to the patient’s catheter and an infusion set which connects to a standard IV catheter.

 

Two investigator-sponsored studies found that RenalGuard “significantly reduced” the incidence of contrast-associated AKI compared to standard-of-care.

 

CardioRenal Systems CEO Ilya Budik said: “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. 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 hospitalisation and most importantly to improve patients’ quality of life.”

 

James Spargo


Related Content

No items found

Latest content