Roivios, a clinical-stage medical device company, has announced FDA Investigational Device Exemption (IDE) approval for its JuxtaFlow Renal Assist Device (RAD). This clearance allows the company to proceed with a pivotal clinical trial to evaluate the device's safety and effectiveness in treating cardiac surgery patients with renal insufficiency.
The GRADIENT (Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic surgery outcomes) trial is a prospective, multicenter, randomized, controlled, open-label study. It aims to enroll patients with renal insufficiency (eGFR 15-60 ml/min) undergoing elective or urgent cardiac surgery requiring cardiopulmonary bypass (CPB). The trial will assess JuxtaFlow's ability to sustain or enhance renal function during and following CPB surgery.
JuxtaFlow Mechanism and Breakthrough Designation
JuxtaFlow is designed to improve kidney function during acute stress. It employs a unique, gentle negative pressure technique on the kidneys’ urine-collecting system. This enhances blood filtration and shields against hypoxia-induced damage. The system combines a catheter, inserted by a trained urologist, and a pump to deliver the negative pressure. The negative pressure transmits through the nephrons, reducing downstream hydrostatic pressure, which allows for effective filtration and selective reabsorption.
In April, JuxtaFlow received FDA Breakthrough Device designation. This designation is granted to devices that have the potential to provide more effective treatment for life-threatening or irreversibly debilitating diseases or conditions.
Clinical Need and Expert Opinion
Cardiac surgery patients undergoing CPB often face increased risks of postoperative complications, including worsening renal dysfunction, which can lead to extended ICU stays and increased mortality. The GRADIENT trial seeks to address the critical need for renal support in these patients.
"The GRADIENT Trial offers an invaluable opportunity to further explore renal support during cardiac surgery," said Dr. Evelio Rodriguez, a 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."
Company Perspective
"Achieving breakthrough device designation was instrumental in securing IDE approval," said John Erbey, CEO at Roivios. "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."
