Teleflex receives FDA clearance to expand QuikClot Control+™ device indications for all grades of bleeding, enhancing patient care.
Quiver AI Summary
Teleflex Incorporated announced the FDA 510(k) clearance for an expansion of the QuikClot Control+™ Hemostatic Device's indications, now including all grades of internal and external bleeding. Previously, the device was only indicated for severe cases, but the expansion aims to address a broader range of bleeding scenarios, thereby enhancing clinical and economic outcomes, particularly in trauma, general surgery, gynecologic surgery, and orthopedics. The decision was supported by real-world evidence from a study involving 603 patients, confirming the device's effectiveness in varied scenarios. Teleflex estimates this expansion could increase their addressable market in the U.S. by over $150 million. The QuikClot Control+™ is now approved for temporary control of all levels of bleeding in both the U.S. and the EU.
Potential Positives
- FDA 510(k) clearance for the QuikClot Control+™ Hemostatic Device expands its indications to all grades of internal and external bleeding, enhancing its market applicability.
- Estimated additional $150 million serviceable addressable market in the U.S. due to the expanded indications, indicating strong revenue growth potential.
- Real-world evidence used for FDA clearance reinforces the product's effectiveness and safety across a broad patient population, strengthening credibility with clinicians.
Potential Negatives
- Expansion of the device's indications comes amid increasing scrutiny over the efficacy and safety of medical devices, which could raise questions about its reliability in the broader range of applications.
- Teleflex's reliance on real-world evidence (RWE) for FDA clearance may face skepticism, especially considering the inherent limitations and biases of observational studies compared to randomized controlled trials.
- While the expansion opens new market opportunities estimated at $150 million, there is a risk of over-promotion and possible overuse of the device, which may lead to negative outcomes or liability issues in clinical settings.
FAQ
What recent FDA clearance did Teleflex receive?
Teleflex received FDA 510(k) clearance to expand the Indications for Use of the QuikClot Control+™ Device for all grades of bleeding.
What is the QuikClot Control+™ Hemostatic Device used for?
The QuikClot Control+™ Device is used for temporary control of mild to life-threatening internal and external bleeding.
How does the new indication benefit healthcare providers?
The expanded indication allows healthcare providers to use the device in more surgical procedures, enhancing patient outcomes and safety.
What research supported the FDA clearance for the QuikClot Control+™ Device?
Real-world evidence from a study of 603 patients demonstrated the device's effectiveness and safety in controlling various grades of bleeding.
In what regions is the QuikClot Control+™ Device indicated?
The device is indicated in the United States and the European Union for managing mild to severe bleeding from injuries and surgical wounds.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$TFX Congressional Stock Trading
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Full Release
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.
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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.
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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:
Johnston, SS, Afolabi, M, Tewari, R, Danker, W.
ClinicoEconomics and Outcomes Research
. 2023;15:535-547.
Internal estimate.
Contacts:
Teleflex
Lawrence Keusch
Vice President, Investor Relations and Strategy Development
investor.relations@teleflex.com
610-948-2836
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