FDA Approval for Pivotal Trial of Innovative JuxtaFlow® Renal Assist Device Marks Significant Milestone in Kidney Health

FDA Grants IDE Approval for JuxtaFlow® Renal Assist Device

Roivios, a frontrunner in the clinical stage of medical innovation, has reached a significant milestone by securing FDA approval for the Investigational Device Exemption (IDE). This approval is a precursor to the pivotal trial of its revolutionary JuxtaFlow Renal Assist Device (RAD), which aims to enhance kidney health outcomes for patients undergoing cardiac surgery.

The forthcoming GRADIENT Trial (Groundbreaking Renal Assist Device Intervening to Enhance cardioThoracic surgery outcomes) is designed to cater specifically to cardiac surgery patients who suffer from renal insufficiency. These individuals often face increased risks of complications post-surgery that can jeopardize their recovery by exacerbating kidney issues. As a result, it is critical to implement renal support during procedures that require cardiopulmonary bypass (CPB).

Dr. Evelio Rodriguez, a prominent heart surgeon from Ascension Saint Thomas in Nashville, TN, has stepped forward as the National Principal Investigator of the GRADIENT trial. He expressed the importance of this trial, stating, "The GRADIENT Trial offers an invaluable opportunity to further explore renal support during cardiac surgery. The JuxtaFlow device offers new hope for some of our most vulnerable patients."

The JuxtaFlow RAD is built with groundbreaking technology designed to optimally support kidney function during periods of acute stress. Its innovative approach entails gentle suction applied to the kidney's outlet, seeking to improve blood filtration efficiency. Recognizing its potential impact on kidney health, the FDA previously designated the device as a Breakthrough Device back in April.

The GRADIENT study is structured as a prospective, multicenter, randomized, controlled, open-label trial, with plans to enroll patients experiencing renal insufficiency (eGFR of 15-60 ml/min) who are gearing up for either elective or urgent cardiac surgery necessitating CPB. This comprehensive research aims to assess both the safety and effectiveness of the JuxtaFlow RAD in maintaining or enhancing renal function throughout and after surgery.

John Erbey, CEO of Roivios, acknowledged the significance of the Breakthrough Device Designation in facilitating IDE approval. He stated, "Achieving Breakthrough Device Designation was instrumental in securing IDE approval. 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."

The JuxtaFlow RAD is not just another medical device; it stands as a pioneering investigational tool poised to redefine kidney support therapy. It tackles the detrimental effects of fluid overload and pressure on the kidneys. By moving beyond traditional filtration methods that may further harm the kidneys, Roivios employs controlled negative pressure to optimize the filtering process within the kidney's collecting system. This advanced strategy may foster the maintenance and enhancement of kidney function, thus significantly aiding patient recovery and potentially reducing hospital stays, which in turn translates to lowered healthcare costs.

Equipped with custom catheters and pumps designed specifically for optimal kidney function during critical recovery phases, the JuxtaFlow RAD is currently still under investigation and is not available for commercial sale.

Roivios remains committed to advancing kidney health solutions, looking to not only improve renal outcomes but potentially mitigate the need for dialysis while cutting down healthcare expenses. The firm also plans to extend its innovations to various medical settings beyond kidney disease management, steering towards a transformative U.S. launch aimed at redefining this field and enhancing life quality for patients.

For further insight into Roivios and the JuxtaFlow Renal Assist Device, you may visit Roivios.com.