Roivios, a clinical-stage medical device company focused on transforming kidney health, has received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its cutting-edge JuxtaFlow® Renal Assist Device (RAD), marking a significant advancement in safeguarding kidney function during cardiac surgeries.
The JuxtaFlow® RAD utilizes a unique technique of gentle negative pressure on the urine-collecting system of the kidneys to enhance function and protect against damage caused by low oxygen levels. This breakthrough offers new hope for patients facing kidney disease while undergoing heart surgery.
Dr. Mark Stafford-Smith, a prominent Professor of Cardiothoracic Anesthesiology at Duke University, expressed excitement about the device’s potential, stating that the JuxtaFlow® RAD reduced the intensity and duration of decreased kidney oxygen levels in research conducted on pigs. This discovery opens up new avenues for research and strategies to protect patients’ kidneys during heart surgery.
John Erbey, CEO of Roivios, emphasized the significance of securing the Breakthrough Device Designation, highlighting the company’s commitment to advancing kidney health innovation. He also mentioned the upcoming release of the BIPASS-AKI clinical data, which will further showcase the device’s effectiveness.
At the Society of Cardiovascular Anesthesiologists (SCA) Annual Meeting, Roivios will present compelling preclinical data demonstrating how the JuxtaFlow® RAD mitigates the harmful effects of cardiopulmonary bypass on the kidneys. The device has the potential to reduce ICU stays, minimize emergency dialysis requirements, and generate significant cost savings for healthcare providers.
With the planned U.S. launch of the JuxtaFlow® RAD in late 2025, Roivios aims to revolutionize kidney health management beyond cardiac thoracic surgery. The company aims to improve outcomes throughout the intensive care unit, offering a preemptive approach to managing kidney disease and enhancing patient quality of life.
For more information about Roivios and the JuxtaFlow® Renal Assist Device, please visit Roivios.com.
About Roivios:
Roivios is a clinical-stage medical device company dedicated to pioneering solutions for kidney health. Its flagship product, the JuxtaFlow® Renal Assist Device (RAD), is designed to preserve kidney function, reduce the need for dialysis, and lower healthcare costs. With plans to expand its application beyond kidney disease, Roivios aims to redefine kidney disease management and improve patient quality of life. Learn more at roivios.com.
This release contains forward-looking statements subject to risks and uncertainties. Actual results may differ significantly.
Media Contact: Kelly Krueger, Krueger PR, [email protected]
SOURCE Roivios, ltd
The article discusses Roivios, a medical device company that has received the Breakthrough Device Designation from the FDA for its JuxtaFlow® Renal Assist Device (RAD), which aims to safeguard kidney function during cardiac surgeries. Here are some additional facts and information to provide a more comprehensive discussion on the topic:
1. Current Market Trends:
– Kidney disease is a significant health issue globally, with an increasing number of people requiring dialysis or kidney transplantation.
– The demand for innovative technologies and devices that can improve kidney health and function during cardiac surgeries is on the rise.
– There is a growing focus on reducing complications and improving patient outcomes in the field of cardiac surgery, including the preservation of kidney function.
2. Forecasts:
– The global market for kidney health devices is expected to experience significant growth in the coming years, driven by the increasing prevalence of kidney disease and advancements in medical technology.
– The adoption of breakthrough devices like the JuxtaFlow® RAD has the potential to revolutionize kidney health management in cardiac surgery and could expand to other areas of healthcare, leading to improved patient outcomes and cost savings.
3. Key Challenges and Controversies:
– Despite advancements in medical technology, protecting kidney function during cardiac surgeries remains a challenge.
– Some controversies may arise regarding the cost-effectiveness of innovative devices like the JuxtaFlow® RAD and the extent of their impact on patient outcomes.
– Ensuring widespread adoption and integration of such breakthrough devices into clinical practice may face resistance due to existing healthcare protocols and practices.
Advantages of the JuxtaFlow® RAD:
– The use of gentle negative pressure on the urine-collecting system of the kidneys is a unique technique that enhances kidney function while protecting against damage caused by low oxygen levels.
– The device has shown promising results in preclinical studies, reducing the intensity and duration of decreased kidney oxygen levels.
– By preserving kidney function, the JuxtaFlow® RAD has the potential to reduce the need for emergency dialysis and decrease ICU stays, leading to improved patient outcomes and cost savings for healthcare providers.
Disadvantages of the JuxtaFlow® RAD:
– The specific limitations and potential disadvantages of the JuxtaFlow® RAD are not mentioned in the article.
– Without further information, it is difficult to determine any potential drawbacks or challenges associated with the device.
For more information about Roivios and the JuxtaFlow® Renal Assist Device, please visit Roivios.com.
Note: The provided link to Roivios.com is for reference only and should be verified for validity before use. The URL in this response has been modified for the format requested.