What's Happening?
CytoSorbents Corporation has received an FDA appeal decision regarding its De Novo application for DrugSorb-ATR, a device aimed at reducing perioperative bleeding in CABG patients on ticagrelor. The FDA upheld its denial, citing the need for additional information to support the label indication. Despite the denial, the FDA found no issues with device safety and proposed a potential path forward for market authorization. CytoSorbents is evaluating further appeal options within the FDA and continues discussions to clarify the proposed path. The company remains committed to bringing DrugSorb-ATR to U.S. patients, addressing the risk of severe bleeding associated with blood thinners.
Why It's Important?
The FDA's decision impacts CytoSorbents' ability to market DrugSorb-ATR in the U.S., potentially delaying access to a device that could benefit heart attack patients requiring urgent surgery. The denial highlights the challenges companies face in obtaining FDA approval, emphasizing the need for comprehensive data to support new medical devices. The proposed path forward offers hope for eventual approval, which could improve surgical outcomes and reduce bleeding risks for patients on blood thinners. The decision also underscores the importance of ongoing collaboration between companies and regulatory agencies to address safety and efficacy concerns.
What's Next?
CytoSorbents is considering filing an appeal to a higher level within the FDA, which must be done within 30 days of the decision. The company will continue discussions with the FDA to explore the proposed path forward for DrugSorb-ATR's market authorization. If successful, this could lead to the device's approval and commercialization in the U.S., providing a new treatment option for patients undergoing CABG surgery. The outcome of these discussions and potential appeal will be closely watched by stakeholders, including healthcare providers and patients, who stand to benefit from improved surgical safety.
