Rachel Klemovitch, Assistant Editor04.26.24
Roivios, a clinical-stage medical device company focusing on kidney health, has been awarded the Breakthrough Device Designation by the FDA for its JuxtaFlow Renal Assist Device (RAD), thanks to the BIPASS-AKI feasibility study. This marks a leap forward in safeguarding kidney function for patients undergoing cardiac surgeries and addresses a key challenge in cardiothoracic surgery and critical care.
The JuxtaFlow RAD uses a negative pressure technique on the kidneys’ urine collecting system to improve function and shield against hypoxia-induced damage under acute conditions. This device aims to change the treatment paradigm for patients facing kidney disease during cardiac surgery.
Roivios CEO John Erbey said, “Securing the Breakthrough Device Designation marks a crucial milestone for Roivios and underscores our dedication to advancing kidney health innovation. We eagerly anticipate sharing the BIPASS-AKI clinical data soon. We are proud to lead with innovative solutions like the JuxtaFlow RAD, which not only supports our unique approach but also our commitment to improving outcomes across a wide spectrum of conditions."
Dr. Mark Stafford-Smith, a leading Professor of Cardiothoracic Anesthesiology at Duke University, commented: "It's become clear that low oxygen levels in the kidneys during heart surgery are increasingly recognized as a predictor of acute kidney injury (AKI) and other complications after the operation. Despite numerous attempts with medications to address this issue, we've seen limited success. However, in our research where we replicated heart surgery on pigs, the JuxtaFlow RAD device reduced both the intensity and duration of decreased kidney oxygen levels. This discovery opens up exciting new avenues for research and strategies to safeguard the kidneys in patients undergoing heart surgery."
Roivios will showcase the JuxtaFlow RAD at the Society of Cardiovascular Anesthesiologists (SCA) Annual Meeting. According the the company, this device is poised to reduce ICU stays, minimize the need for emergency dialysis, and generate substantial savings for healthcare providers.
JuxtaFlow RAD is expacted to launch in the US in late 2025, and Roivios is set to expand the device's application beyond cardiac thoracic surgery, aiming to revolutionize kidney health management throughout the intensive care unit.
The JuxtaFlow RAD uses a negative pressure technique on the kidneys’ urine collecting system to improve function and shield against hypoxia-induced damage under acute conditions. This device aims to change the treatment paradigm for patients facing kidney disease during cardiac surgery.
Roivios CEO John Erbey said, “Securing the Breakthrough Device Designation marks a crucial milestone for Roivios and underscores our dedication to advancing kidney health innovation. We eagerly anticipate sharing the BIPASS-AKI clinical data soon. We are proud to lead with innovative solutions like the JuxtaFlow RAD, which not only supports our unique approach but also our commitment to improving outcomes across a wide spectrum of conditions."
Dr. Mark Stafford-Smith, a leading Professor of Cardiothoracic Anesthesiology at Duke University, commented: "It's become clear that low oxygen levels in the kidneys during heart surgery are increasingly recognized as a predictor of acute kidney injury (AKI) and other complications after the operation. Despite numerous attempts with medications to address this issue, we've seen limited success. However, in our research where we replicated heart surgery on pigs, the JuxtaFlow RAD device reduced both the intensity and duration of decreased kidney oxygen levels. This discovery opens up exciting new avenues for research and strategies to safeguard the kidneys in patients undergoing heart surgery."
Roivios will showcase the JuxtaFlow RAD at the Society of Cardiovascular Anesthesiologists (SCA) Annual Meeting. According the the company, this device is poised to reduce ICU stays, minimize the need for emergency dialysis, and generate substantial savings for healthcare providers.
JuxtaFlow RAD is expacted to launch in the US in late 2025, and Roivios is set to expand the device's application beyond cardiac thoracic surgery, aiming to revolutionize kidney health management throughout the intensive care unit.