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Teleflex Receives FDA Clearance for Expanded Indication for Specialty Catheter and Coronary Guidewire Use in CTO PCI Procedures
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., February 23, 2022—Teleflex Incorporated, a 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, SpectreTM Guidewire, RaiderTM Guidewire, BanditTM Guidewire, WarriorTM Guidewire, and R350TM 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.
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.
