Teleflex Announces First Patient Enrollment in CTO-PCI IDE Study

Rhea-AI Summary

Teleflex Incorporated (NYSE: TFX) has announced the enrollment of the first patient in a pivotal clinical study evaluating the effectiveness of its coronary guidewires and specialty catheters in Chronic Total Occlusion (CTO) procedures. The CTO-PCI study aims to enroll up to 150 patients at roughly 15 sites across the US. The study will assess key metrics, including successful guidewire placement and major adverse cardiac events. The principal investigators from notable institutions emphasize the importance of this research in enhancing techniques for treating complex coronary blockages.

Positive

• Initiation of the CTO-PCI study could enhance Teleflex's reputation in interventional cardiology.
• The research may lead to improved clinical outcomes in treating Chronic Total Occlusions.
• Collaboration with respected institutions could validate Teleflex's technology and products.

Negative

• None.

WAYNE, Pa., June 02, 2020 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced the first patient enrollment in a clinical study that will evaluate the performance of Teleflex coronary guidewires and specialty catheters in Chronic Total Occlusion (CTO) percutaneous coronary intervention (PCI) procedures, which is currently an investigational indication for these products. Enrolling up to 150 patients across approximately 15 investigational sites in the US, the CTO-PCI Study is a prospective, single-arm IDE study employing the primary angiographic endpoint of successful (intralumenal) guidewire placement beyond the CTO.

CTOs are longstanding complete blockages in coronary arteries that usually result in profound regional reduction of coronary blood flow (ischemia). 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

The principal investigators of the study include David E. Kandzari, MD, Director, Interventional Cardiology and Chief Scientific Officer at Piedmont Heart Institute, Atlanta, GA, and Dimitrios Karmpaliotis, MD, Director of CTO, Complex and High-Risk PCI at Columbia University Irving Medical Center. “We’re excited to embark on the Teleflex CTO study,” said Dr. Kandzari. “We expect the study results to inform contemporary technique in CTO revascularization—a lesion complexity that has long been recognized as the most challenging in interventional cardiology.”

In addition to measuring procedure success and the absence of major adverse cardiac events (MACE), the study will evaluate the frequency of successful recanalization, frequency of MACE in-hospital and at 30 days post-procedure, frequency of clinically significant perforation, procedural success according to crossing technique, and technical success (defined as successful guidewire recanalization using Teleflex study devices).

Study devices include the GuideLiner® V3 catheter, TrapLiner® catheter, Turnpike® catheter, and a series of five coronary guidewires (Spectre^TM Guidewire, R350^TM Guidewire, Raider^TM Guidewire, Warrior^TM Guidewire and Bandit^TM Guidewire). Each study device is currently commercially available in the US under a more general indication. These products are investigational devices for clinical evaluation as used in the CTO-PCI study.

“The CTO-PCI study, led by Drs. Kandzari and Karmpaliotis, will evaluate the performance of the entire range of Teleflex complex PCI products in the most demanding PCI environment: chronic occlusive coronary disease,” said Teleflex Medical Director, Chris Buller, MD. “The resourcing of this study by Teleflex reflects our commitment to providing the most advanced tools for our customers and their patients.”

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^®, Hudson RCI^®, LMA^®, Pilling^®, 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, Hudson RCI, LMA, Pilling, Rusch, UroLift, and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

© 2020 Teleflex Incorporated. All rights reserved. MC-005909 Rev 1

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.

Source:

Teleflex Incorporated
Jake Elguicze
Treasurer and Vice President, Investor Relations
610-948-2836

FAQ

What is the CTO-PCI study initiated by Teleflex?

The CTO-PCI study is a clinical trial to evaluate the performance of Teleflex's coronary guidewires and catheters in treating Chronic Total Occlusions (CTOs).

How many patients are expected to enroll in the Teleflex CTO-PCI study?

The study aims to enroll up to 150 patients across approximately 15 investigational sites in the US.

Who are the principal investigators of the Teleflex CTO-PCI study?

The principal investigators include Dr. David E. Kandzari and Dr. Dimitrios Karmpaliotis.

What are the goals of the Teleflex CTO-PCI study?

The study aims to measure successful guidewire placement and evaluate major adverse cardiac events (MACE) among other key metrics.

What products are being evaluated in the Teleflex CTO-PCI study?

The study evaluates various Teleflex coronary guidewires and specialty catheters, including GuideLiner® V3 and TrapLiner® catheters.

When was the first patient enrolled in the Teleflex CTO-PCI study?

The first patient was enrolled in the study on June 02, 2020.