Roivios, a pioneering clinical-stage medical device company dedicated to revolutionising kidney health, announced 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.
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“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.”
JuxtaFlow RAD is an innovative device designed to potentially improve kidney function during times of acute stress. By applying a gentle suction to the kidney’s outlet, it aims to enhance blood filtration more efficiently. This groundbreaking approach was recognized with an FDA Breakthrough Device Designation in April.
The GRADIENT study will be a prospective, multicenter, randomized, controlled, open-label trial that plans to enroll patients with renal insufficiency (eGFR 15-60 ml/min) undergoing elective or urgent cardiac surgery requiring CPB. The study seeks to evaluate the safety and effectiveness of the JuxtaFlow RAD to sustain or enhance renal function during and following CPB surgery.
“Achieving Breakthrough Device Designation was instrumental in securing IDE approval,” noted John Erbey, Chief Executive Officer at Roivios. “This initiative is the culmination of a decade of technological and clinical advancements in addressing kidney disease management challenges. Our ongoing dialogue with the FDA is paving the way for more effective management, empowering patients to thrive. We are eager to commence IDE enrollment and explore the JuxtaFlow RAD’s potential to improve surgical outcomes and enhance patient quality of life.”
