Teleflex Gains FDA Approval for Expanded Use of QuikClot Control+ Hemostatic Device

WAYNE, PA Teleflex Incorporated (NYSE: TFX) has been granted 510(k) approval by the U.S. Food and Drug Administration (FDA), which permits an expansion in the use indications for their QuikClot Control+™ Hemostatic Device. This new authorization enables the device to address both internal and external bleeding across all severity levels, thus increasing its range of medical uses. Prior to this update, the device had mainly been approved for managing significant blood loss during surgeries and traumatic incidents, particularly dealing with class III and IV injuries within body cavities as well as operations related to the breastbone or heart surgery.

“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 for the QuikClot Control+™ Device portfolio allows us to target more procedures where fast, effective control of bleeding could benefit patients, clinicians, and health systems. Our primary focus remains on trauma, but this expanded indication will also support procedures in general surgery, gynecologic surgery, orthopedic surgery, and other areas. We estimate that these additional clinical spaces add more than $150 million to our serviceable addressable market in the United States.”

The FDA clearance was supported by real-world evidence (RWE) derived from a rigorous observational study of 603 emergency, trauma, and surgical patients. This broad, U.S.-based study assessed the device’s safety and efficacy across multiple anatomical sites and various types of bleeding, providing a foundation for the labeling change.

“Real-world evidence was leveraged by Teleflex to obtain FDA clearance for this clinically important, expanded indication,” said Michelle Fox, Corporate Vice President and Chief Medical Officer, 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.”

The apparatus is currently approved in the U.S. for the provisional management of both minor and major internal as well as external bleeding, ranging from mild to severe and even life-threatening cases. Since 2024, this device, known as QuikClot Control+™, has been accessible for purchase within the European Union and has shown effectiveness in addressing bleeding associated with trauma and surgery.

With this regulatory milestone, Teleflex positions itself to enhance patient outcomes across a wider range of medical procedures while addressing a growing healthcare market. By extending the reach of its innovative hemostatic solutions, Teleflex demonstrates its commitment to advancing clinical practices and improving surgical care worldwide.