Teleflex Receives FDA Clearance for Expanded Indication for Specialty Catheter and Coronary Guidewire Use in CTO PCI Procedures

Rhea-AI Summary

Teleflex has received FDA clearance for expanded use of its specialty catheters and coronary guidewires in chronic total occlusion percutaneous coronary interventions (CTO PCI). CTOs, affecting nearly 20% of patients, are significant blockages that lead to ischemia. The CTO-PCI study demonstrated a 93.3% technical success rate and over 75% procedural success, emphasizing the effectiveness of Teleflex's devices in complex cases. This advancement reflects Teleflex's commitment to innovative medical technologies that enhance patient outcomes.

Positive

• FDA clearance for expanded indications increases market potential for Teleflex's specialty catheters and guidewires.
• 93.3% technical success and over 75% procedural success rate in the CTO-PCI study suggests high reliability of the products.
• Addressing a significant medical need as CTOs are prevalent in approximately 20% of patients undergoing coronary angiography.

Negative

• None.

Results of CTO-PCI IDE Study Demonstrate Procedural Success with Teleflex Specialty Catheters and Coronary Guidewires in Patients Undergoing Chronic Total Occlusion Percutaneous Coronary Interventions

WAYNE, Pa., Feb. 23, 2022 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced that the U.S. Food and Drug Administration (FDA) has cleared an expanded indication for its specialty catheters and coronary guidewires for use in crossing chronic total occlusion percutaneous coronary interventions (CTO PCI).

CTOs are longstanding complete blockages in coronary arteries that result in profound regional reduction of coronary blood flow (ischemia). Importantly, clinically significant CTOs are found in nearly 20% of patients undergoing diagnostic coronary angiography for suspected ischemic heart disease.¹ Often a source of limiting symptoms, CTOs may also contribute to cardiac dysfunction and are associated with poor prognosis.² Approximately 57,000 CTO interventions are performed annually in the US.³

Devices receiving the expanded indication include the Teleflex GuideLiner V3^® Catheter, TrapLiner^® Catheter, Turnpike^® Catheters, Spectre™ Guidewire, Raider™ Guidewire, Bandit™ Guidewire, Warrior™ Guidewire, and R350™ Guidewire. These products were evaluated as part of the CTO-PCI study, a peer-reviewed, prospective, single-arm IDE study that enrolled 150 patients across 13 investigational centers across the United States. In this very complicated cohort, technical success (defined as successful guidewire recanalization) was achieved in 93.3% of cases, and procedural success (i.e., free of major adverse cardiovascular events, MACE) was achieved in over 75% of cases.

David E. Kandzari, MD, Director, Interventional Cardiology and Chief of the Piedmont Heart Institute and Cardiovascular Service Line, Atlanta, GA, was one of the study’s principal investigators.^* “Considering the complexity of both anatomy and procedural strategy in this study, the very favorable success achieved underscores the need for an ‘interventional toolbox’ that features an array of enabling device technologies that include guidewires, guide catheter extensions and microcatheters,” he said. “Given the challenging patient population, the high technical success rate in this most demanding PCI environment is particularly notable.”

“The CTO-PCI IDE study confirmed the safety and effectiveness of a range of these products in very complex CTO cases,” said Teleflex Medical Director, Dr. Christopher Buller. “Interventional cardiologists who have evolved the techniques for these difficult procedures need innovative, enabling devices they can absolutely count on,” he said. “We feel privileged to be a partner in this effort.”

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^®, Rusch^®, 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, Bandit, GuideLiner, R350, Raider, Spectre, TrapLiner, Turnpike, Warrior, Arrow, Deknatel, LMA, Pilling, QuikClot, Rusch, UroLift, and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

© 2022 Teleflex Incorporated. All rights reserved. MC-007863 Rev 0

*Dr. Kandzari is a paid consultant of Teleflex Incorporated.

References:

1. Fefer, P. et al. Current Perspectives on Coronary Chronic Total Occlusions: The Canadian Multicenter Chronic Total Occlusions CTO Registry. Journal of the American College of Cardiology 2012;59 (11): 991-7.

2. Tajstra, P. et al. Impact of Chronic Total Occlusion of the Coronary Artery on Long-Term Prognosis in Patients With Ischemic Systolic Heart Failure: Insights From the COMMIT-HF Registry. JACC: Cardiovascular Interventions 2016; 9 (17): 1790-97.

3. iData Research, US Med Suite, 2020.

Contacts:

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

John Hsu, CFA
Vice President, Investor Relations

investor.relations@teleflex.com
610.948.2836

Source: Teleflex Incorporated

FAQ

What did the FDA clear for Teleflex on February 23, 2022?

The FDA cleared expanded indications for Teleflex's specialty catheters and coronary guidewires for chronic total occlusion percutaneous coronary interventions.

What are the success rates reported in the CTO-PCI study for Teleflex's devices?

The CTO-PCI study reported a 93.3% technical success rate and over 75% procedural success rate.

How many chronic total occlusion interventions are performed annually in the US?

Approximately 57,000 chronic total occlusion interventions are performed annually in the US.

What is the significance of chronic total occlusions in patients?

Chronic total occlusions are major blockages found in nearly 20% of patients and can lead to significant ischemia and cardiac dysfunction.

What is the stock symbol for Teleflex?

The stock symbol for Teleflex is TFX.