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News FDA Grants Breakthrough Device Designation to RenalGuard Therapy

January 25, 2023

1 min read


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The FDA awarded CardioRenal Systems Breakthrough Device designation for its RenalGuard therapy, according to a press release.

“We are delighted to receive Breakthrough Device Designation and thank our team for all the hard work that has brought us here. We look forward to working closely with the FDA and our partners to facilitate the initiation of the upcoming U.S. pivotal study , ” Ilya Budik, CardioRenal Systems CEO said in the release.

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The therapy is designed to prevent AKI in patients at risk of AKI associated with cardiac surgery. source: adobe

The therapy aims to prevent AKI in patients at risk for cardiac surgery-associated AKI (CSA-AKI) by providing personalized and aggressive hydration to the kidney. According to the release, this is achieved by maximizing urine output in an intelligent rehydration system and balancing hydration through monitoring and IV infusions.

“The high prevalence of AKI in cardiac surgery today is a well-known risk,” concluded Budik. “We look forward to further clinical validation that RenalGuard therapy can provide a solution to reduce CSA-AKI prevalence, length of hospital stay and costs, and most importantly, improve quality of life for patients.”

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