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

Rhea-AI Summary

Teleflex has received FDA 510(k) clearance for expanded indications of its QuikClot Control+™ Hemostatic Device, now approved for all grades of internal and external bleeding. This expansion significantly broadens the device's applications beyond its previous indications for specific surgical procedures and bleeding types.

The clearance was supported by real-world evidence from a study of 603 emergency, trauma, and surgical patients across multiple U.S. sites. The expanded indication is expected to add over $150 million to Teleflex's serviceable addressable market in the United States.

The device can now be used for temporary control of external and internal bleeding ranging from mild to life-threatening cases. Already commercialized in the European Union in 2024, this development allows Teleflex to target additional procedures in trauma, general surgery, gynecologic surgery, and orthopedic surgery, potentially improving clinical and economic outcomes.

Positive

• FDA 510(k) clearance expands QuikClot Control+ usage to all grades of internal and external bleeding
• Expanded indications add over $150M to serviceable addressable market in US
• Large real-world evidence study with 603 patients supported FDA approval
• Product already commercialized in EU market since 2024

Negative

• None.

WAYNE, Pa., April 30, 2025 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), 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.

About Teleflex Incorporated
As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose driven innovation, and world-class products can shape the future direction of healthcare.

Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.

At Teleflex, we are empowering the future of healthcare. For more information, please visit www.teleflex.com.

Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management's current beliefs and expectations, but are subject to a number of risks, uncertainties, and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. These risks and uncertainties are identified and described in more detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K.

Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, QuikClot Control+, Rüsch, UroLift, and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.
© 2025 Teleflex Incorporated. All rights reserved. MC-010730

References:

1. Johnston, SS, Afolabi, M, Tewari, R, Danker, W. ClinicoEconomics and Outcomes Research. 2023;15:535-547.
2. Internal estimate.

Contacts:
Teleflex
Lawrence Keusch
Vice President, Investor Relations and Strategy Development
investor.relations@teleflex.com
610-948-2836

FAQ

What new FDA clearance did Teleflex (TFX) receive for QuikClot Control+ in April 2025?

Teleflex received FDA 510(k) clearance to expand QuikClot Control+ usage to include all grades of internal and external bleeding, broadening from its previous limited indications for specific surgical procedures and organ space bleeding.

How much market value does the expanded QuikClot Control+ indication add for Teleflex (TFX)?

The expanded clinical applications add more than $150 million to Teleflex's serviceable addressable market in the United States.

What clinical evidence supported Teleflex's (TFX) QuikClot Control+ FDA expansion?

Teleflex used real-world evidence from a retrospective observational study of 603 emergency, trauma, and surgical patients across multiple U.S. sites, demonstrating effectiveness and safety in controlling all grades of bleeding.

Where can Teleflex's (TFX) QuikClot Control+ device now be used after FDA clearance?

QuikClot Control+ can now be used for temporary control of external and internal bleeding across multiple procedures including trauma, general surgery, gynecologic surgery, orthopedic surgery, and other surgical areas.

What's the difference between QuikClot Control+ approval in the US vs EU for Teleflex (TFX)?

In the EU, QuikClot Control+ was commercialized in 2024 for internal and external mild, moderate, severe, and traumatic bleeding, while the US approval in 2025 expanded to similar comprehensive bleeding control indications.