WAYNE, PA — Teleflex Incorporated (NYSE: TFX) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the Indications for Use of its QuikClot Control+™ Hemostatic Device. The clearance allows the device to be used for all grades of internal and external bleeding, broadening its clinical applications. Previously, the device was primarily indicated for controlling severe bleeding in surgical and trauma settings, including class III and IV internal organ space bleeding, and procedures involving the sternum or cardiac 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 device is now cleared in the U.S. for temporary control of mild, moderate, severe, and life-threatening internal and external bleeding. Already commercially available in the European Union since 2024, the QuikClot Control+™ device has demonstrated its utility in managing traumatic and surgical bleeding.
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.
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