Roivios has secured the US Food and Drug Administration’s (FDA) breakthrough device designation for its JuxtaFlow renal assist device (RAD), designed to provide kidney protection for patients undergoing cardiac surgeries.

This designation follows the positive outcomes of the BIPASS-AKI feasibility study and aligns with new research presented at the Society of Cardiovascular Anesthesiologists (SCA) Annual Meeting.

The FDA’s breakthrough device designation recognises the JuxtaFlow RAD’s potential to transform the current treatment landscape for patients at risk of kidney disease.

This device employs a new negative pressure technique to protect the kidneys from hypoxia-induced damage during acute conditions.

At the SCA Annual Meeting, Roivios will present preclinical data that demonstrates the JuxtaFlow RAD’s efficacy in reducing the adverse effects of cardiopulmonary bypass on kidney function.

This innovation has the potential to shorten ICU stays, decrease the necessity for emergency dialysis, and offer significant cost savings for healthcare systems.

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Roivios CEO John Erbey said: “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.”

With plans for the US launch in late 2025, Roivios aims to broaden the use of the JuxtaFlow RAD beyond cardiothoracic surgery to transform kidney health management across intensive care units.

In December 2023, the final participant was enrolled in the BIPASS-AKI study for the JuxtaFlow RAD at the Institute of Cardiovascular Diseases in Sremska Kamenica, Serbia.