Renal Device for Use in Cardiac Surgeries Gets FDA Breakthrough Designation

The JuxtaFlow Renal Assist Device (RAD) has received a Breakthrough Device designation from the US Food and Drug Administration (FDA).

The device, developed by Roivios, aims to preserve kidney function in patients undergoing cardiac surgeries. JuxtaFlow RAD uses a gentle negative pressure technique on the kidneys’ urine-collecting system to enhance function and protect against hypoxia-induced damage under acute conditions. It has the potential to reduce intensive care unit stays, lessen the need for emergency dialysis, and create substantial savings for health care providers.

Roivios shared preclinical data from the BIPASS-AKI study of JuxtaFlow RAD at the Society of Cardiovascular Anesthesiologists Annual Meeting and called the outcomes “encouraging.” It plans to launch JuxtaFlow RAD in the United States in late 2025. Roivios also wants to expand the device’s application beyond cardiothoracic surgery.

The FDA’s Breakthrough Devices Program was created to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and de novo marketing authorization.