- The FDA has signed off, with conditions, on CytoSorbents' (NASDAQ:CTSO +4.1%) pivotal study, REFRESH 2, assessing the efficacy of intraoperative CytoSorb blood treatment on postoperative acute kidney injury, a common adverse event in patients undergoing complex cardiac surgery.
- The study will enroll up to 400 subjects undergoing elective, non-emergent open heart surgery for valve replacement or aortic reconstruction with hypothermic cardiac arrest (deliberately lowering body temperature to stop the heart and systemic blood flow).
- Control patients will receive standard-of-care (SOC) treatment during surgery while the test group will receive SOC with dual parallel CytoSorb cartridges in a heart-lung machine bypass circuit aimed at reducing toxins from the blood.
- The company says REFRESH 2 will begin shortly.