Teleflex’s QuikClot Control+ Hemostatic Device cleared by FDA for expanded use

Teleflex (TFX) announced FDA 510(k) clearance of an expansion to the Indications for Use of the QuikClot Control+ Hemostatic Device to include all grades of internal and external bleeding. The QuikClot Control+ Device was previously indicated 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. To support the labeling change, Teleflex used real-world evidence from a retrospective, statistically powered, observational study of 603 emergency, trauma, and surgical patients. The study assessed the effectiveness and safety of the QuikClot Control+ Device to control all grades of bleeding in multiple and varied anatomical sites during surgical procedures and in bleeding due to injuries. The QuikClot Control+ Hemostatic Device is now indicated for temporary control of external and identifiable sites of internal mild, moderate, severe, and life-threatening bleeding in the U.S., and for temporary control of internal and external mild, moderate, severe, and traumatic bleeding due to injuries and/or surgical wounds in the EU and was commercialized in the EU in 2024.