FDA grants breakthrough device designation to RenalGuard Therapy
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The FDA granted CardioRenal Systems breakthrough device designation for its RenalGuard Therapy, according to a press release.
"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 U.S. pivotal study," Ilya Budik, CEO of CardioRenal Systems, said in the release.
The therapy is designed to prevent AKI in patients at risk for cardiac surgery-associated AKI (CSA-AKI) by providing the kidneys with personalized and active hydration. According to the release, this occurs by maximizing urine output and balancing hydration with monitoring and IV infusion in a smart re-hydration system.
“The high prevalence of AKI in cardiac surgery today is a well-known risk,” Budik concluded. “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."
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