Teleflex Incorporated, a leading global provider of medical technologies, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of an expansion to the Indications for Use of the QuikClot Control+™ Hemostatic Device to include all grades of internal and external bleeding. The QuikClot Control+™ Device was previously indicated for temporary control of class III and class IV internal organ space bleeding, severely bleeding surgical wounds, mild and moderate bleeding in cardiac surgical procedures, and bone surfaces following sternotomy.

“Bleeding remains a major contributor to mortality and morbidity in the United States,” said Kevin Robinson, President and General Manager, Anesthesia and Emergency Medicine, Teleflex. “Uncontrolled, disruptive bleeding can significantly impact the clinical and economic outcomes of surgery.1 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.2”

To support the labeling change, Teleflex used real-world evidence (RWE) from a retrospective, statistically powered, observational study of 603 emergency, trauma, and surgical patients. The study assessed the effectiveness and safety of the QuikClot Control+™ Device to control all grades of bleeding in multiple and varied anatomical sites during surgical procedures and in bleeding due to injuries. The RWE, representing a broad patient population from multiple sites across the U.S., led to the FDA clearance of the expanded indications.

“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 QuikClot Control+™ Hemostatic Device is now indicated for temporary control of external and identifiable sites of internal mild, moderate, severe, and life-threatening bleeding in the United States.

The QuikClot Control+™ Hemostatic Device is indicated for temporary control of internal and external mild, moderate, severe, and traumatic bleeding due to injuries and/or surgical wounds in the European Union (EU) and was commercialized in the EU in 2024.

 

Source: globenewswire.com

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