US-based medical device company Teleflex has received the US Food and Drug Administration (FDA) expanded 510(k) approval for its QuikClot Control+ Hemostatic Device.
Previously, the device was limited to class three and four internal organ space bleeding, severely bleeding surgical wounds, and mild to moderate bleeding in cardiac procedures.
The approval expands its indications to include all internal and external bleeding grades.
In the US, the QuikClot Control+ Hemostatic Device is now approved for temporary control of external and identifiable internal bleeding, ranging from mild to life-threatening.
In the European Union (EU), the device is indicated for managing internal and external bleeding due to injuries or surgical wounds and was commercialised in 2024.
Teleflex anaesthesia and emergency medicine president and general manager Kevin Robinson said: “Bleeding remains a major contributor to mortality and morbidity in the United States. 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, gynaecologic surgery, orthopaedic 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 expanded approval was supported by real-world evidence from a retrospective study involving 603 emergency, trauma, and surgical patients.
The study evaluated the device’s effectiveness and safety in controlling various bleeding scenarios across multiple anatomical sites during surgeries and injury-related bleeding.
The data, reflecting a broad US patient population, was instrumental in securing FDA approval for the expanded indications.
Teleflex corporate vice president and chief medical officer Michelle Fox said: “Real-world evidence was leveraged by Teleflex to obtain FDA clearance for this clinically important, expanded indication.
“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.”
Recently, Teleflex received the US FDA 510(k) clearance for its AC3 Range Intra-Aortic Balloon Pump (IABP), designed based on the company’s AC3 Optimus IABP.
