Roivios has announced receipt of the FDA’s investigational device exemption (IDE), allowing them to conduct trials for their renal assist device (RAD). The IDE approval paves the way for pivotal trials with the JuxtaFlow RAD, targeting patients with kidney issues undergoing cardiac surgery. This milestone follows the FDA’s breakthrough device designation for JuxtaFlow earlier in April.
Based in the Bahamas, Roivios created JuxtaFlow to optimize treatment for those experiencing renal complications during heart operations. The device employs a specialized, gentle negative pressure approach on the kidneys’ urine collection system, enhancing functionality and providing protection against damage due to low oxygen conditions.
JuxtaFlow’s design features a combination of catheter and pump. During the procedure, a qualified urologist inserts these catheters akin to ureteral stent installations. Following insertion, the catheter links to the pump that administers the negative pressure. This pressure is designed to traverse the nephrons, minimizing subsequent hydrostatic pressure. This controlled pressure relief ensures efficient filtration and selective reabsorption processes.
The company’s GRADIENT trial will focus on addressing the critical need for renal support in patients undergoing cardiopulmonary bypass (CPB). The trial is structured as a prospective, multicenter, randomized, controlled, open-label study to evaluate JuxtaFlow’s safety and effectiveness in maintaining or enhancing kidney function during and post-CPB surgery.
“Securing the breakthrough device designation was crucial in obtaining the IDE approval,” stated John Erbey, CEO of Roivios. “This project represents over ten years of technological and clinical strides in tackling kidney disease management. Our continuous discussions with the FDA are leading to improved management strategies empowering patients. We are excited to begin IDE enrollment and to uncover JuxtaFlow RAD’s capability to elevate surgical outcomes and boost patient quality of life.”