Teleflex Receives FDA Clearance for Expanded Indication for QuikClot Control+™ Hemostatic Device Usage in Cardiac Surgical Procedures

Rhea-AI Summary

Teleflex Incorporated (NYSE: TFX) announces FDA clearance for expanded use of QuikClot Control+™ Hemostatic Device in cardiac surgical procedures, offering a new solution for intraoperative bleeding control. The device also received expanded intended uses to include patients on anticoagulation/antiplatelet medication, use with or without autotransfusion equipment, and use with or without cardiopulmonary bypass systems.

Positive

• The FDA clearance for expanded use of the QuikClot Control+™ Hemostatic Device opens up a significant market opportunity, with over 600,000 open cardiothoracic procedures performed in the U.S. each year. Teleflex's research showing the device's superiority in achieving clinical hemostasis for mild and moderate cardiac surgery bleeding, with a more than 20% higher proportion of achieving hemostasis at both 5 and 10 minute intervals compared to standard gauze, is a positive indicator for potential increased adoption and usage of the device.

Negative

• None.

WAYNE, Pa., Aug. 01, 2023 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced the U.S Food and Drug Administration (FDA) has cleared the QuikClot Control+^™ Hemostatic Device to include mild and moderate bleeding in cardiac surgical procedures and bone surface bleeding following a sternotomy. This allows clinicians to use the QuikClot Control+^™ Device to control all bleeding in cardiac surgical procedures.

The expanded indications enable device utilization across a wider patient population and breadth of surgical procedures. With Teleflex research showing more than 600,000 open cardiothoracic procedures are performed in the U.S. each year, cardiovascular and cardiothoracic surgeons now have an additional solution for intraoperative bleeding control. The QuikClot Control+^™ Hemostatic Device also received expanded intended uses to include use with patients on anticoagulation/antiplatelet medication, use with or without autotransfusion (blood salvage) equipment, and use with or without cardiopulmonary bypass systems.

The FDA clearance follows the completion and analysis of the 2021 cardiac investigational device exemption (IDE) study, which examined the percentage of patients who achieved hemostasis in the first 10 minutes of hemostatic application and compression at the bleeding site, as well as safety outcomes. The study, recently published in The Journal of Thoracic and Cardiovascular Surgery (JTCVS) Open, concluded that the QuikClot Control+^™ Hemostatic Device was superior to standard gauze in achieving clinical hemostasis for mild and moderate cardiac surgery bleeding.¹ Additionally, there was no significant difference in safety outcomes. Study participants receiving the QuikClot Control+^™ Hemostatic Device achieved hemostasis at more than 20% higher proportion at both 5 and 10 minute intervals when compared to those receiving standard gauze.¹

“We are excited to provide an additional tool to address bleeding control for cardiac surgeons,” said Kevin Robinson, President and General Manager, Anesthesia and Emergency Medicine Division, Teleflex. “We look forward to supporting positive patient outcomes in these procedures through the expanded use potential of our QuikClot Control+^™ Devices.”

About Teleflex Incorporated
Teleflex is a global provider of medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular access, interventional cardiology and radiology, anesthesia, emergency medicine, surgical, urology and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.

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

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, 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.
© 2023 Teleflex Incorporated. All rights reserved. MC-008284

References:

1. Mumtaz M, Thompson RB, Moon MR, Sultan I, Reece TB, Keeling WB, DeLaRosa J. (2023). Safety and efficacy of a kaolin-impregnated hemostatic gauze in cardiac surgery: A randomized trial. JTCVS Open. 2023;14:134-144.
   
   

Contacts:
Teleflex Incorporated:
Lawrence Keusch
Vice President, Investor Relations and Strategy Development

investors.teleflex.com
610-948-2836

 

FAQ

What is the news about Teleflex Incorporated (NYSE: TFX)?

Teleflex Incorporated (NYSE: TFX) announces FDA clearance for expanded use of QuikClot Control+™ Hemostatic Device in cardiac surgical procedures, offering a new solution for intraoperative bleeding control.

What are the expanded intended uses of the QuikClot Control+™ Hemostatic Device?

The device received expanded intended uses to include patients on anticoagulation/antiplatelet medication, use with or without autotransfusion equipment, and use with or without cardiopulmonary bypass systems.

What is the potential market impact of the FDA clearance for the QuikClot Control+™ Hemostatic Device?

The FDA clearance for expanded use of the QuikClot Control+™ Hemostatic Device opens up a significant market opportunity, with over 600,000 open cardiothoracic procedures performed in the U.S. each year. Teleflex's research showing the device's superiority in achieving clinical hemostasis for mild and moderate cardiac surgery bleeding, with a more than 20% higher proportion of achieving hemostasis at both 5 and 10 minute intervals compared to standard gauze, is a positive indicator for potential increased adoption and usage of the device.