The JuxtaFlow system progresses to pivotal trials, offering hope for cardiac surgery patients with renal insufficiency.
FDA Greenlights JuxtaFlow for Pivotal Study
Roivios has received FDA investigational device exemption (IDE) approval to evaluate its JuxtaFlow renal assist device (RAD) in cardiac surgery patients experiencing renal insufficiency. This pivotal trial follows the FDA’s Breakthrough Device Designation granted in April 2024.
A Novel Approach to Kidney Support
JuxtaFlow leverages advanced technology to protect kidneys during cardiac surgery by:
- Applying gentle negative pressure: Enhances filtration and shields against hypoxia-induced damage.
- Integrating a catheter and pump system: Enables precise pressure modulation to support nephron function and reduce hydrostatic stress.
Trained urologists perform catheter placement similarly to ureteral stent procedures, connecting the device to deliver controlled pressure reductions.
The GRADIENT Trial: Addressing Critical Need
The multicenter, randomized GRADIENT trial will evaluate JuxtaFlow’s safety and effectiveness in sustaining renal function during and after cardiopulmonary bypass (CPB). The study addresses an urgent need for renal support among CPB patients, aiming to reduce complications and improve outcomes.
Leadership Perspective
“Securing FDA IDE approval marks a major milestone,” said John Erbey, CEO at Roivios. “This trial is the result of years of innovation, and we’re excited to explore JuxtaFlow’s potential to improve surgical outcomes and patient quality of life.”
Advancing Kidney Care Innovation
JuxtaFlow represents a decade of research dedicated to redefining renal care in acute surgical settings. With pivotal trials underway, the device could become a vital tool in addressing kidney-related challenges during cardiac surgery.
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