Teleflex has announced that the US 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 ischaemia. Importantly, clinically significant CTOs are found in nearly 20% of patients undergoing diagnostic coronary angiography for suspected ischaemic 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 USA.
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 centres across the USA. 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, Teleflex said in a press release.
David Kandzari, (Piedmont Heart Institute, Atlanta, USA) was one of the study’s principal investigators. He commented: “Considering the complexity of both anatomy and procedural strategy in this study, the very favourable 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. 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, 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.”