Home » CardioRenal Systems’ RenalGuard Therapy Gets Breakthrough Nod
CardioRenal Systems’ RenalGuard Therapy Gets Breakthrough Nod
Devices Regulatory Affairs
The FDA has granted Breakthrough Device status to CardioRenal Systems’ RenalGuard therapy to prevent acute kidney injury in cardiac surgery-patients.
RenalGuard addresses the common surgery complication by hydrating the patient using intravenous infusion and real-time monitoring of urine output.
Acute kidney injury occurs in up to 30 percent of cardiac surgery cases in the U.S., Europe and the Middle East, the company said.
The Breakthrough Devices program provides timely access to medical devices by speeding up the development, assessment, and review of the devices.