Teleflex receives FDA 510(k) Clearance for Expanded Indications of the QuikClot Control+™ Hemostatic Device

Core Insights - Teleflex Incorporated has received FDA 510(k) clearance for an expanded indication of the QuikClot Control+™ Hemostatic Device, now covering all grades of internal and external bleeding [1][2][3] Company Overview - Teleflex is a global provider of medical technologies, focusing on improving health and quality of life through innovative solutions in various therapy areas including anesthesia, emergency medicine, and surgical procedures [5][6] Product Expansion - The QuikClot Control+™ Device was previously limited to class III and IV internal organ space bleeding and has now been expanded to include mild, moderate, severe, and life-threatening bleeding [1][3] - The expansion is expected to add over $150 million to Teleflex's serviceable addressable market in the U.S. [2] Clinical Evidence - The FDA clearance was supported by real-world evidence from a study involving 603 patients, demonstrating the device's effectiveness and safety across multiple anatomical sites [2][3] Market Impact - The expanded indication allows Teleflex to target a broader range of surgical procedures, including general surgery, gynecologic surgery, and orthopedic surgery, enhancing the potential for improved clinical outcomes [2][3]