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Roivios secures FDA breakthrough device designation for JuxtaFlow RAD

Roivios announced that it has been awarded the prestigious Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its cutting-edge JuxtaFlow® Renal Assist Device (RAD). This landmark recognition, fueled by the encouraging outcomes of the BIPASS-AKI feasibility study, coincides with the unveiling of pioneering research at the Society of Cardiovascular Anesthesiologists (SCA) Annual Meeting.

The Breakthrough Device Designation emphasizes the JuxtaFlow® RAD’s potential to profoundly change the treatment paradigm for patients facing kidney disease during cardiac surgery. 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.

Highlighting the device’s transformative potential, Dr. Mark Stafford-Smith, a leading Professor of Cardiothoracic Anesthesiology at Duke University, stated, “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. Despite numerous attempts with medications to address this issue, we’ve seen limited success. However, in our research where we replicated heart surgery on pigs, the JuxtaFlow® RAD device reduced both the intensity and duration of decreased kidney oxygen levels. This discovery opens up exciting new avenues for research and strategies to safeguard the kidneys in patients undergoing heart surgery.”

John Erbey, CEO of Roivios, reflected on the significance of this achievement saying, “Securing the Breakthrough Device Designation marks a crucial milestone for Roivios and underscores our dedication to advancing kidney health innovation. We eagerly anticipate sharing the BIPASS-AKI clinical data soon. We are proud to lead with innovative solutions like the JuxtaFlow® RAD, which not only supports our unique approach but also our commitment to improving outcomes across a wide spectrum of conditions.”

At the SCA Annual Meeting, Roivios will showcase the compelling preclinical data showcasing the impact of the JuxtaFlow® RAD on mitigating the harmful effects of cardiopulmonary bypass on the kidneys. This breakthrough is poised to reduce ICU stays, minimize the need for emergency dialysis, and generate substantial savings for healthcare providers.

With the anticipated U.S. launch of the JuxtaFlow® RAD in late 2025, Roivios is set to expand the device’s application beyond cardiac thoracic surgery, aiming to revolutionize kidney health management throughout the intensive care unit.
MB Bureau

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