WAYNE, PA — Teleflex Incorporated (NYSE: TFX) has been granted 510(k) approval by the U.S. Food and Drug Administration (FDA), expanding the range of uses for their QuikClot Control+™ Hemostatic Device. This new authorization enables the device to address both minor and major types of internal and external bleeding, thus increasing its potential medical applications. Prior to this expansion, the primary use of the device focused on managing critical bleeding during surgeries and traumatic incidents, such as class III and IV hemorrhaging within body cavities, along with operations related to the breastbone or heart surgery.
Bleeding continues to be a significant factor contributing to death and disease in the U.S.," said Kevin Robinson, President and General Manager of Anesthesia and Emergency Medicine at Teleflex. "Unmanaged, chaotic hemorrhaging can greatly affect both surgical outcomes and costs. Expanding the use indications for the QuikClot Control+™ Device lineup enables us to apply them in more medical scenarios where swift and efficient hemostasis would help patients, healthcare providers, and hospital networks. While we primarily aim at treating traumatic injuries, this broader application scope will also cover surgeries like those performed in general, gynecological, and orthopedic fields among others. This extended reach into various clinical settings boosts our potential market size within the country by over $150 million.
The FDA approval was backed by real-world evidence (RWE) obtained from an extensive observational study involving 603 emergency, trauma, and surgery patients in the U.S. This wide-ranging study evaluated the device's safety and effectiveness at different body locations and with varied forms of hemorrhaging, establishing a basis for updating the product information labels.
Teleflex utilized real-world evidence to secure FDA approval for this significant expansion in indications," stated Michelle Fox, Corporate Vice President and Chief Medical Officer at Teleflex. "This allows us to extend the benefits of the QuikClot Control+™ Device portfolio to a greater number of healthcare providers, enabling them to enhance bleeding management across various levels—from surgical procedures to emergency resuscitations.
The device is currently approved in the U.S. for temporarily controlling mild, moderate, severe, and even life-threatening internal and external bleeding. Since 2024, this QuikClot Control+™ device has been commercially accessible in the European Union and has shown its effectiveness in addressing both traumatic and surgical hemorrhaging.
This regulatory achievement allows Teleflex to improve patient results over an expanded array of medical procedures and cater to the expanding healthcare sector. Through broadening access to their advanced hemostatic products, Teleflex shows its dedication to progressing clinical standards and enhancing global surgical treatment.
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