26 December 2017 - - The US Food and Drug Administration has granted approval of Monmouth Junction, New Jersey-based blood purification specialist CytoSorbents Corp.'s (NASDAQ: CTSO) REFRESH 2 investigational device exemption (IDE) application, with conditions, the company said.
These conditions relate to requested clarifications and changes to the patient consent form and instructions for use document, which have now been modified.
Based on FDA guidance, study initiation and patient enrollment can now begin at each clinical center with site institutional review board approval and the revised documentation.
The REFRESH 2 trial is a randomized, controlled, multi-center, clinical trial designed to evaluate intraoperative CytoSorb use as a therapy to reduce acute kidney injury, as measured by Kidney Disease Improving Global Outcomes (KDIGO) criteria, following complex cardiac surgery.
The trial will enroll up to 400 patients undergoing elective, non-emergent open heart surgery for either valve replacement, or aortic reconstruction with hypothermic cardiac arrest.
Control patients will receive standard of care during surgery, while treatment patients will receive standard of care with dual parallel CytoSorb cartridges in a heart-lung machine bypass circuit that are intended to reduce toxic inflammatory mediators and renal toxins such as plasma free hemoglobin and activated complement, during surgery.
Other secondary and exploratory endpoints include time on mechanical ventilation, the use of vasopressors or other hemodynamic support, days in the intensive care unit, reduction in inflammatory mediators, and mortality at 30 days.
CytoSorbents is a critical care focused immunotherapy company that engages in the research, development, and commercialisation of medical devices with its platform blood purification technology incorporating a proprietary adsorbent, porous polymer technology.