February 23, 2022 – Teleflex Incorporated 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. Often a source of limiting symptoms, CTOs may also contribute to cardiac dysfunction and are associated with poor prognosis. Approximately 57,000 CTO interventions are performed annually in the US.
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.