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# Roivios Gets Breakthrough Status on Renal Assist
- URL: https://www.fdaweb.com/roivios-gets-breakthrough-status-on-renal-assist/
- Published: 2024-04-26T12:00:00.000Z
- Updated: 2026-09-14T14:29:24.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156865

FDA has granted Roivios a breakthrough device designation for its JuxtaFlow Renal Assist Device and its use in safeguarding kidney function for patients undergoing cardiac surgeries. The device uses a “unique, gentle negative pressure technique on the kidneys’ urine-collecting system to enhance function and shield against hypoxia-induced damage under acute conditions,” the company says. “It’s become clear that low oxygen levels in the kidneys during heart surgery are increasingly recognized as a predictor of acute kidney injury (AKI) and other complications after the operation.”

The company’s research replicated heart surgery on pigs and the device reduced both the intensity and duration of decreased kidney oxygen levels, Roivios says. It expects to launch the device in late 2025\. Plans are underway to expand the device’'s application beyond cardiac thoracic surgery, including throughout the intensive care unit, it says.