Teleflex receives FDA 510(k) Clearance for Expanded Indications of the QuikClot Control+™ Hemostatic Device
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.
Teleflex ha ottenuto l'autorizzazione FDA 510(k) per l'ampliamento delle indicazioni del suo Dispositivo Emostatico QuikClot Control+™, ora approvato per tutti i tipi di sanguinamento interno ed esterno. Questa estensione amplia notevolmente le applicazioni del dispositivo oltre le precedenti indicazioni specifiche per alcune procedure chirurgiche e tipi di sanguinamento.
L'autorizzazione è stata supportata da dati reali provenienti da uno studio su 603 pazienti in situazioni di emergenza, trauma e chirurgia in diversi centri degli Stati Uniti. Si prevede che la nuova indicazione possa aggiungere oltre 150 milioni di dollari al mercato indirizzabile di Teleflex negli Stati Uniti.
Il dispositivo può ora essere utilizzato per il controllo temporaneo di sanguinamenti esterni e interni, da lievi a casi potenzialmente letali. Già commercializzato nell'Unione Europea nel 2024, questo sviluppo consente a Teleflex di rivolgersi a ulteriori procedure in trauma, chirurgia generale, ginecologia e ortopedia, migliorando potenzialmente i risultati clinici ed economici.
Teleflex ha recibido la autorización FDA 510(k) para ampliar las indicaciones de su Dispositivo Hemostático QuikClot Control+™, ahora aprobado para todos los grados de sangrado interno y externo. Esta expansión amplía significativamente las aplicaciones del dispositivo más allá de sus indicaciones anteriores para procedimientos quirúrgicos específicos y tipos de sangrado.
La autorización se basó en evidencia del mundo real obtenida en un estudio con 603 pacientes de emergencia, trauma y cirugía en múltiples sitios de EE. UU. Se espera que la nueva indicación añada más de 150 millones de dólares al mercado direccionable de Teleflex en Estados Unidos.
El dispositivo ahora puede usarse para el control temporal de sangrados externos e internos, desde casos leves hasta potencialmente mortales. Ya comercializado en la Unión Europea en 2024, este avance permite a Teleflex dirigirse a procedimientos adicionales en trauma, cirugía general, cirugía ginecológica y ortopédica, mejorando potencialmente los resultados clínicos y económicos.
텔레플렉스는 자사의 QuikClot Control+™ 지혈 장치에 대해 FDA 510(k) 승인을 받아 내외부 모든 등급의 출혈에 대한 적응증을 확장하였습니다. 이번 확장으로 장치는 이전의 특정 수술 절차 및 출혈 유형에 한정된 적응증을 넘어 그 적용 범위가 크게 확대되었습니다.
이번 승인은 미국 내 여러 병원에서 응급, 외상, 수술 환자 603명을 대상으로 한 실제 데이터에 기반하였습니다. 확장된 적응증은 미국 내 텔레플렉스의 서비스 가능 시장에 1억 5천만 달러 이상의 추가 가치를 가져올 것으로 예상됩니다.
이 장치는 이제 경미한 출혈부터 생명을 위협하는 출혈까지 내외부 출혈의 일시적 제어에 사용할 수 있습니다. 2024년 유럽연합에서 이미 상용화된 이 개발은 텔레플렉스가 외상, 일반 수술, 부인과 수술, 정형외과 수술 등 추가 절차를 대상으로 하여 임상 및 경제적 성과를 향상시킬 수 있게 합니다.
Teleflex a obtenu l'autorisation FDA 510(k) pour étendre les indications de son Dispositif hémostatique QuikClot Control+™, désormais approuvé pour tous les grades de saignement interne et externe. Cette extension élargit considérablement les applications du dispositif au-delà de ses indications précédentes pour des procédures chirurgicales spécifiques et certains types de saignements.
Cette autorisation a été appuyée par des données du monde réel issues d'une étude menée auprès de 603 patients en situation d'urgence, de traumatologie et de chirurgie dans plusieurs sites aux États-Unis. L'indication élargie devrait ajouter plus de 150 millions de dollars au marché adressable de Teleflex aux États-Unis.
Le dispositif peut désormais être utilisé pour le contrôle temporaire des saignements externes et internes, allant des cas légers aux situations potentiellement mortelles. Déjà commercialisé dans l'Union européenne en 2024, ce développement permet à Teleflex de cibler des procédures supplémentaires en traumatologie, chirurgie générale, gynécologie et chirurgie orthopédique, améliorant potentiellement les résultats cliniques et économiques.
Teleflex hat die FDA 510(k)-Zulassung für erweiterte Anwendungsgebiete seines QuikClot Control+™ Hämostase-Geräts erhalten, das nun für alle Grade von inneren und äußeren Blutungen zugelassen ist. Diese Erweiterung vergrößert die Einsatzmöglichkeiten des Geräts erheblich über die bisherigen Indikationen für spezifische chirurgische Eingriffe und Blutungsarten hinaus.
Die Zulassung wurde durch Real-World-Daten aus einer Studie mit 603 Notfall-, Trauma- und chirurgischen Patienten an mehreren Standorten in den USA gestützt. Die erweiterte Indikation wird erwartet, den adressierbaren Service-Markt von Teleflex in den USA um über 150 Millionen US-Dollar zu erhöhen.
Das Gerät kann nun zur temporären Kontrolle von äußeren und inneren Blutungen eingesetzt werden, von milden bis hin zu lebensbedrohlichen Fällen. Bereits 2024 in der Europäischen Union kommerzialisiert, ermöglicht diese Entwicklung Teleflex, zusätzliche Verfahren in Trauma-, Allgemein-, Gynäkologie- und Orthopädiechirurgie anzusprechen und möglicherweise klinische und wirtschaftliche Ergebnisse zu verbessern.
- 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
- None.
Insights
Teleflex's FDA clearance expands QuikClot device market by $150M+ in US, opening new surgical applications beyond trauma.
Teleflex has secured a significant regulatory win with FDA 510(k) clearance expanding the indications for its QuikClot Control+™ Hemostatic Device to include all grades of internal and external bleeding, substantially broadening its clinical applications. This regulatory milestone directly expands Teleflex's
The expanded indication strategically positions the company to target additional lucrative procedural segments beyond trauma, including general surgery, gynecologic surgery, and orthopedic surgery. Notably, Teleflex achieved this expansion through an efficient regulatory pathway using real-world evidence (RWE) from a retrospective study of 603 patients rather than conducting costly new clinical trials.
This approval harmonizes the US labeling with existing European Union authorization, where the expanded indication was already commercialized in 2024. From a market perspective, this creates immediate access to high-volume surgical specialties where effective bleeding control directly impacts clinical and economic outcomes of procedures. The ability to address bleeding across the severity spectrum with a single device aligns with healthcare systems' needs for cost-effective, versatile solutions that can improve operational efficiency.
FDA clearance enables QuikClot device to address all bleeding severities across multiple specialties, improving treatment options for clinicians.
The expanded FDA clearance for Teleflex's QuikClot Control+™ Device represents meaningful clinical progress in bleeding management. Previously limited to class III and IV internal organ bleeding and specific surgical applications, the device can now be utilized across the complete spectrum of bleeding severities from mild to life-threatening.
Uncontrolled bleeding remains a significant contributor to mortality and morbidity across multiple clinical scenarios. The expanded indication provides clinicians with a consistent hemostatic solution applicable across diverse anatomical sites and bleeding scenarios. The real-world evidence supporting this clearance came from a substantial cohort of 603 emergency, trauma, and surgical patients, demonstrating effectiveness across multiple anatomical sites.
From a clinical workflow perspective, having a single hemostatic solution applicable to multiple bleeding scenarios creates procedural consistency for surgical teams. The device's versatility across specialties including trauma, general surgery, gynecologic surgery, and orthopedic procedures simplifies inventory management while providing standardized approaches to bleeding management. This expanded indication directly addresses critical needs in bleeding control from emergency resuscitation to planned surgical interventions, potentially streamlining treatment protocols across departments.
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
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
FAQ
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