NASSAU, Bahamas, Dec. 19, 2024 /PRNewswire/ — Roivios, a pioneering clinical-stage medical device company dedicated to revolutionizing kidney health, proudly announces that its research and development arm, 3ive Labs, has secured approval for an Investigational Device Exemption (IDE) from the FDA. This approval paves the way for a pivotal trial of the JuxtaFlow Renal Assist Device (RAD), marking a transformative step forward in enhancing outcomes for cardiac surgery patients with renal insufficiency.

The GRADIENT (Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic surgery outcomes) trial is designed to address the critical need for renal support among cardiac surgery patients undergoing cardiopulmonary bypass (CPB). These patients often face increased risks of postoperative complications, such as worsening renal dysfunction, which can lead to extended ICU stays and increased mortality.

“The GRADIENT Trial offers an invaluable opportunity to further explore renal support during cardiac surgery,” said Dr. Evelio Rodriguez, a renowned heart surgeon at Ascension Saint Thomas in Nashville, TN, and the National Principal Investigator of the GRADIENT trial. “The JuxtaFlow device offers new hope for some of our most vulnerable patients.”