Teleflex Incorporated (NYSE: TFX) has secured a significant regulatory win with the U.S. Food and Drug Administration (FDA) granting 510(k) clearance for expanded indications of its QuikClot Control+ Hemostatic Device. The device is now approved for temporary control of all grades of internal and external bleeding, substantially broadening its clinical applications beyond its previous indications.
Previously, the QuikClot Control+ was primarily indicated for controlling severe bleeding scenarios, including class III and IV internal organ space bleeding, severely bleeding surgical wounds, and procedures involving cardiac surgery or the sternum. The new clearance extends its use to mild and moderate bleeding cases across various surgical specialties.
Addressing a Critical Healthcare Need
"Bleeding remains a major contributor to mortality and morbidity in the United States," stated Kevin Robinson, President and General Manager of Anesthesia and Emergency Medicine at Teleflex. "Uncontrolled, disruptive bleeding can significantly impact the clinical and economic outcomes of surgery."
The expanded indication allows Teleflex to target more procedures where rapid and effective control of bleeding could benefit patients, clinicians, and health systems. While trauma remains the primary focus, the device will now support procedures in general surgery, gynecologic surgery, orthopedic surgery, and other specialties.
According to company estimates, these additional clinical applications add more than $150 million to Teleflex's serviceable addressable market in the United States alone.
Real-World Evidence Supports Expanded Use
The FDA clearance was supported by compelling real-world evidence derived from a retrospective, statistically powered observational study involving 603 emergency, trauma, and surgical patients. This comprehensive U.S.-based study assessed the device's effectiveness and safety in controlling all grades of bleeding across multiple anatomical sites during surgical procedures and in bleeding due to injuries.
"Real-world evidence was leveraged by Teleflex to obtain FDA clearance for this clinically important, expanded indication," explained Michelle Fox, Corporate Vice President and Chief Medical Officer at Teleflex. "This means we are able to bring the technology of the QuikClot Control+ Device portfolio to more clinicians who will benefit from its ability to provide improved bleeding control for all grades of bleeding, from surgery to resuscitation."
Global Availability and Market Position
The QuikClot Control+ Hemostatic Device is now indicated in the United States for temporary control of external and identifiable sites of internal mild, moderate, severe, and life-threatening bleeding. The device has been commercially available in the European Union since 2024, where it is indicated for temporary control of internal and external mild, moderate, severe, and traumatic bleeding due to injuries and/or surgical wounds.
Clinical and Economic Impact
Uncontrolled bleeding during surgical procedures can lead to significant complications, extended hospital stays, and increased healthcare costs. Effective hemostatic devices like QuikClot Control+ can potentially reduce these adverse outcomes by providing faster and more reliable bleeding control.
The expanded indications position Teleflex to enhance patient outcomes across a wider range of medical procedures while addressing a growing healthcare market need. By extending the reach of its innovative hemostatic solutions, Teleflex demonstrates its commitment to advancing clinical practices and improving surgical care worldwide.
About Teleflex
Teleflex Incorporated is a global provider of medical technologies focused on improving the health and quality of people's lives. The company offers a diverse portfolio with solutions in anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology.
Teleflex is the home of several trusted medical brands including Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift, and Weck. The company continues to focus on purpose-driven innovation and developing world-class products that can shape the future direction of healthcare.
