Teleflex Incorporated has achieved a significant regulatory milestone with the FDA’s expanded clearance of its QuikClot Control+™ Hemostatic Device, which is now approved for managing all classifications of internal and external bleeding. Due to this development, surgeons across various specialties gain access to a versatile bleeding control solution with demonstrated effectiveness in both emergency and elective settings.

This development broadens the device’s clinical utility beyond its original trauma and surgical applications to include general, gynecologic, and orthopedic procedures. According to Teleflex Incorporated, this may potentially increase the QuikClot Control+™ Hemostatic Device’s addressable market by $150 million in the U.S. alone. The clearance was supported by a robust retrospective study involving 603 patients across multiple medical centers. The study demonstrated the product’s efficacy across diverse bleeding scenarios.

Notably, this marks one of the first instances where real-world evidence has successfully facilitated an FDA indication expansion for a hemostatic device.

Image Credit: Teleflex Incorporated