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FDA Grants Breakthrough Device Designation to RenalGuard Therapy

25 January 2023

1 min read


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The FDA granted CardioRenal Systems breakthrough device designation for its RenalGuard Therapy, according to a news release.

“We are thrilled to receive the breakthrough device designation and appreciate all the hard work our team has put into getting us here. We look forward to working closely with the FDA and our partners to facilitate the initiation of the upcoming US pivotal study,” Ilya Shop, CEO of CardioRenal Systems, said in the announcement.

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The treatment is designed to prevent AKI in patients at risk of cardiac surgery-associated AKI. Source: Adobe Stock

The treatment is designed to prevent AKI in patients at risk of cardiac surgery-associated AKI (CSA-AKI) by providing personalized and active hydration to the kidneys. According to the release, this is done by maximizing urine output and balancing hydration with monitoring and IV infusion in a smart rehydration system.

“The high incidence of AKI in cardiac surgery today is a well-known risk,” concluded Budik. “We look forward to building further clinical validation that RenalGuard Therapy can provide the solution to reduce the incidence of CSA-AKI, the length and cost of hospitalization, and most importantly, improve patients’ quality of life.”

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