Roivios has announced that they have enrolled the final patient for the BIPASS-AKI study for the JuxtaFlow renal assist device (RAD). The American Heart Hospital in Bielsko Biala, Poland, The Institute for Cardiovascular Disease Dedinje, Serbia, and The Institute of Cardiovascular Disease, Sremska Kamenica in Serbia were all included as sites for the study. This final site was the highest enrolling, and was led by principal investigator Milovan Petrovic (Institute of Cardiovascular Diseases, Sremska Kamenica, Serbia) et al.
Cardiac surgery-associated acute kidney injury (CSA-AKI) was documented in 73% of patients who were identified as having pre-existing renal insufficiency as part of their standard pre-surgical workup. CSA-AKI can then impact a patient’s ability to recover from surgery, which then leads to a longer hospital stay and a higher cost. As well as this, it can also lead to a higher risk of morbidity and mortality, and can increase the need for more frequent chronic dialysis treatment. The JuxtaFlow RAD is intended to be used in a hospital setting, with the intention of enabling the kidneys to function optimally, thereby leading to better overall patient outcomes.
When asked to comment, Petrovic said: “When we began this feasibility trial, we anticipated the use of the JuxtaFlow RAD to be an exciting moment. We frequently perform cardiac surgery on patients with renal impairment and they are among our most complicated cases, so we are proud to have enrolled several patients into this study to contribute insights into this novel therapy in advance of its pivotal trial.”
John Erbey, chief executive officer of Roivios, also commented that: “The mission of Roivios is to give clinicians the tools to protect, preserve and improve kidney function. Cardiac surgery is a major stress on the kidneys, and today these patients have few options. Our team is inspired to design a system that would assist critical renal function during times of acute stress, employing an innovative solution that enhances the kidneys’ own natural function to support recovery.” He continued, adding that they are “incredibly excited” to have completed the first step in providing this novel therapy for at-risk patients and serve as “the bridge to their successful recovery”.
“We look forward to sharing this BIPASS-AKI data shortly and then continuing to partner with hospitals, surgeons, and critical care teams around the world who share our vision for reducing this all-too-frequent adverse event of surgery.”
