Teleflex Completes Enrollment in CTO-PCI IDE Study

Rhea-AI Summary

Teleflex Incorporated (NYSE: TFX) has successfully completed patient enrollment ahead of schedule in its clinical study evaluating specialty catheters and coronary guidewires for Chronic Total Occlusion (CTO) percutaneous coronary interventions. The study enrolled 150 patients across 13 US sites, concluding three months early. CTOs affect nearly 20% of patients undergoing coronary angiography, often leading to severe ischemia and cardiac dysfunction. The study aims to assess device performance and safety, with expectations for results to inform clinical practices in CTO procedures.

Positive

• Enrollment completed three months ahead of schedule.
• Study involves 150 patients, indicating strong interest in CTO procedures.
• Enrolling physicians are reputable experts in interventional cardiology.

Negative

• None.

Enrollment Completed Ahead of Schedule in Study Evaluating the Performance of Teleflex Specialty Catheters and Coronary Guidewires in Patients Undergoing Chronic Total Occlusion Percutaneous Coronary Interventions

WAYNE, Pa., Feb. 17, 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 Teleflex specialty catheters and coronary guidewires in Chronic Total Occlusion (CTO) percutaneous coronary intervention (PCI) procedures—currently an investigational indication for these products. The study enrolled 150 patients across 13 investigational sites in the US and completed enrollment three months ahead of schedule. 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 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, MD³, Director, Interventional Cardiology and Chief of the Piedmont Heart Institute and Cardiovascular Service Line, Atlanta, GA, and Dimitri Karmpaliotis, MD, Director of CTO, Complex and High-Risk PCI at Columbia University Irving Medical Center. “The fast enrollment in the CTO-PCI study reflects the strong interest in further advancing contemporary techniques in CTO revascularization—the most demanding PCI environment,” said Dr. Kandzari.

In addition to measuring procedure success and the absence of major adverse cardiac events (MACE), the study is evaluating 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).

Enrolling 30 of the 150 patients, Khaldoon Alaswad, MD³, Director, Cardiac Catheterization Laboratory at Henry Ford Hospital, Detroit, MI, was the lead enroller in the study. “The study results will enhance the CTO-PCI skill set and inform interventionalists about the performance of the Teleflex product line in CTO procedures,” said Dr. Alaswad.

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.

“We are very encouraged by the brisk enrollment in the CTO-PCI IDE study and look forward to the results,” said Teleflex Medical Director, Dr. Christopher Buller.

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.

© 2021 Teleflex Incorporated. All rights reserved. MC-007026 Rev 0.1

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.

3. Drs. Kandzari and Alaswad are paid consultants of Teleflex or its affiliates.

Source:

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

FAQ

What is the significance of the enrollment completion in Teleflex's CTO-PCI study?

The early completion indicates strong interest and may enhance the understanding of device performance in treating CTOs.

How many patients were enrolled in the Teleflex CTO-PCI study?

The study enrolled 150 patients across 13 investigational sites.

What is the expected outcome of the Teleflex CTO-PCI study?

The study aims to assess the safety and effectiveness of Teleflex's catheter and guidewire devices in CTO PCI procedures.

What is TFX's role in the CTO-PCI study?

TFX, or Teleflex, is the company providing the specialty catheters and guidewires being evaluated in the clinical study.

When was the Teleflex CTO-PCI study enrollment completed?

The enrollment was completed on February 17, 2021.