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

February 25, 2022 – Teleflex Incorporated, 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.”

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.

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