Teleflex CTO PCI Specialty Catheters and Guidewires Receive FDA Clearance for Expanded Indication

February 23, 2022—Teleflex Incorporated announced that the FDA has cleared an expanded indication for its specialty catheters and coronary guidewires for use in crossing chronic total occlusion (CTO) during percutaneous coronary intervention (PCI).

According to the company, 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 investigational device exemption (IDE) study that enrolled 150 patients at 13 investigational centers across the United States.

Teleflex stated that in this very complicated cohort, technical success (defined as successful guidewire recanalization) was achieved in 93.3% of cases, and procedural success defined as freedom from major adverse cardiovascular events was achieved in > 75% of cases.

David E. Kandzari, MD, who is Director, Interventional Cardiology and Chief of the Piedmont Heart Institute and Cardiovascular Service Line in Atlanta, Georgia, 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,” commented Dr. Kandzari in the company’s press release. “Given the challenging patient population, the high technical success rate in this most demanding PCI environment is particularly notable.”

Teleflex Medical Director Christopher Buller, MD, added, “The CTO-PCI IDE study confirmed the safety and effectiveness of a range of these products in very complex CTO cases. 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.”