The expanded indications now include all grades of internal and external bleeding. QuikClot Control+ previously had clearance for temporary control of class III and class IV internal organ space bleeding, severely bleeding surgical wounds, mild and moderate bleeding in cardiac surgical procedures and bone surfaces following sternotomy.

Wayne, Pennsylvania-based Teleflex used real-world evidence to support the label change. Data from a study of 603 emergency, trauma and surgical patients backed the expansion. The study assessed the effectiveness and safety of QuikClot Control+ to control all grades of bleeding. It evaluated multiple and varied anatomical sites during surgical procedures and bleeding due to ijuries.

Teleflex said the real-world evidence represented a broad patient population across multiple U.S. sites.