Teleflex wins FDA clearance for expanded indications of CTO specialty catheters, guidewires

Teleflex (NYSE:TFX) today announced that it received FDA clearance for expanded indication for its specialty catheters and coronary guidewires for use in crossing chronic total occlusion percutaneous coronary interventions (CTO PCI).

Devices that are included in the expanded indication are the Teleflex GuideLiner V3 catheter, TrapLiner catheter, Turnpike catheters, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire and R350 guidewire.

Each device was evaluated as part of the CTO-PCI study, which was a peer-reviewed, prospective, single-arm IDE study that enrolled 150 patients across 13 investigational centers in the U.S. Successful guidewire recanalization was achieved in 93.3% of cases with procedural success in over 75% of cases.

“The CTO-PCI IDE study confirmed the safety and effectiveness of a range of these products in very complex CTO cases,” Teleflex medical director Christopher Biller said in a news release. “Interventional cardiologists who have evolved the techniques for these difficult procedures need innovative, enabling devices they can absolutely count on. We feel privileged to be a partner in this effort.”

CTOs are complete blockages in coronary arteries that result in a regional reduction of coronary blood flow. It is found in nearly 20% of patients who are undergoing diagnostic coronary angiography for suspected ischemic heart disease, according to Teleflex.

“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,” said David Kandzari, director of interventional cardiology and chief of the Piedmont Heart Institute and Cardiovascular Service Line in Atlanta and one of the CTO-PCI study’s principal investigators. “Given the challenging patient population, the high technical success rate in this most demanding PCI environment is particularly notable.”