Teleflex catheters, coronary guidewires gain expanded indication for CTO-PCI
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Teleflex Inc. announced that the FDA has granted an expanded indication for its specialty catheters and coronary guidewires for use in PCI for chronic total occlusions.
According to a company press release, the expanded indication includes multiple devices (Teleflex GuideLiner V3 Catheter, TrapLiner Catheter, Turnpike Catheters, Spectre Guidewire, Raider Guidewire, Bandit Guidewire, Warrior Guidewire and R350 Guidewire).
The expanded indication is based on the results of the CTO-PCI prospective, single-arm study that enrolled 150 patients across 13 investigational centers in the U.S. According to the release, technical success, defined as successful guidewire recanalization, was achieved in 93.3% of cases, and procedural success, defined as no MACE, was achieved in more than 75% 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 of interventional cardiology, chief of the Piedmont Heart Institute and Cardiovascular Service Line in Atlanta and principal investigator of the CTO-PCI study, said in the release. “Given the challenging patient population, the high technical success rate in this most demanding PCI environment is particularly notable.”
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