Teleflex Completes Enrollment in Cardiac IDE Study

Rhea-AI Summary

Teleflex (NYSE: TFX) has completed patient enrollment in a clinical study assessing the QuikClot Control+® Hemostatic Device for mild to moderate bleeding during cardiac surgeries. The study, which aimed to measure hemostasis rates, enrolled 231 patients across seven sites, finishing three months ahead of schedule. Principal investigators express optimism about sharing findings related to various cardiac procedures. The QuikClot Control+® is FDA-cleared for severe bleeding but is investigational in this study, with plans for a 510(k) filing upon analysis completion.

Positive

• Completed patient enrollment in study three months ahead of schedule.
• Study involves 231 patients across seven sites, indicating strong interest and participation.
• Potential for expanded use of QuikClot Control+® after analysis, improving market positioning.
• Primary and secondary endpoints focus on rapid hemostasis, supporting advanced patient care.

Negative

• None.

Study Evaluates Effectiveness of QuikClot Control+® Hemostatic Device in Patients Undergoing Cardiac Surgery

WAYNE, Pa., Oct. 27, 2021 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced the completion of patient enrollment in a clinical study evaluating the performance of the QuikClot Control+^® Hemostatic Device for mild to moderate (Class I and II) bleeding in cardiac procedures as compared to standard gauze. The primary efficacy endpoint of this prospective, randomized, controlled Cardiac IDE study is the rate at which subjects achieved hemostasis through 10 minutes of hemostatic application and compression at the bleeding site. The secondary efficacy endpoint is the proportion of subjects achieving hemostasis measured at 5 and 10 minutes. The study enrolled 231 patients across seven investigational sites in the U.S. and completed enrollment three months ahead of schedule.

The principal investigators of the Cardiac IDE study include Mubashir A. Mumtaz, MD, Chief of Cardiothoracic Surgery and Surgical Director of the Structural Heart Program at UPMC Central Pennsylvania, and Marc Moon, MD, Section Chief of Cardiac Surgery, at Washington University School of Medicine in St. Louis and past president of the American Association for Thoracic Surgery.

“We are pleased to participate in this study to explore the use of the QuikClot Control+^® Hemostatic Device in cardiac surgery,” said Dr. Mumtaz. “We look forward to sharing the results of its use in various aspects of cardiac surgery including coronary artery bypass grafting (CABG), valve repair/replacement, and thoracic aortic surgeries.*”

The QuikClot Control+^® Hemostatic Device is the first FDA-cleared hemostatic dressing indicated for severe (Class III and IV) bleeding in the internal organ space and is currently commercially available in the U.S. The product is considered an investigational device for clinical evaluation in the Cardiac IDE study.

“More than 600,000 cardiothoracic procedures are performed in the U.S. each year, according to Teleflex research,” said Kevin Robinson, President and General Manager, Anesthesia and Emergency Medicine Division, Teleflex. “Our goal is to offer surgeons another tool to support positive patient outcomes in these procedures. We anticipate submitting a 510(k) filing for expanded use of the QuikClot Control+^® Device following completion of the study analysis.”

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.
© 2021 Teleflex Incorporated. All rights reserved. MC-007626

References:
* Intended uses under IDE trial are pending FDA submission and clearance

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

John Hsu, CFA
Vice President, Investor Relations
investors.teleflex.com
610-948-2836

FAQ

What is the purpose of the QuikClot Control+® Hemostatic Device study involving TFX?

The study aims to evaluate the device's effectiveness in achieving hemostasis for mild to moderate bleeding during cardiac surgeries.

How many patients were enrolled in the TFX QuikClot study?

The study enrolled 231 patients across seven investigational sites in the U.S.

What are the key endpoints of the QuikClot Control+® study for TFX?

The primary endpoint is the rate of achieving hemostasis within 10 minutes, with secondary endpoints at 5 and 10 minutes.

When was the patient enrollment for the TFX study completed?

Patient enrollment was completed on October 27, 2021, three months ahead of schedule.

What is the future plan for the QuikClot Control+® Device after the TFX study?

Following the study analysis, Teleflex anticipates filing for expanded use through a 510(k) submission.