Teleflex’s Specialty Catheters, Coronary Guidewires Gain Expanded FDA OK

Teleflex has received U.S. Food and Drug Administration (FDA) clearance to expand its specialty catheters and coronary guidewires to use in crossing chronic percutaneous coronary interventions (CTO PCI). CTOs are longstanding complete coronary artery blockages resulting in ischemia.
 
Devices earning the expanded indication include the Teleflex GuideLiner V3 catheter, TrapLiner catheter, Turnpike catheters, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire, and R350 guidewire.
 
The expanded indication was supported by the 150-patient CTO-PCI study, which reported successful guidewire recanalization in 93.3 percent or patients, and no major adverse cardiovascular events in over 75 percent of cases.
 
“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,” David E. Kandzari, MD, Director, Interventional Cardiology and Chief of the Piedmont Heart Institute and Cardiovascular Service Line and one of the study’s principal investigators, told the press. “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,” added 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.”