Teleflex Gets FDA’s 510(k) Clearance for Expanded Indication for Specialty Catheter

Teleflex has received the FDA’s 510(k) clearance for an expanded indication for several specialty catheters and coronary guidewires for use in crossing chronic total occlusions in coronary arteries.

The agency granted the expanded indication to the Teleflex GuideLiner V3, TrapLiner and Turnpike catheters, and to the Spectre, Raider, Bandit, Warrior and R350 guidewires, the company said.

The devices were evaluated in an investigational device exemption study that enrolled 150 patients in 13 sites across the U.S. Technical success, defined as successful guidewire recanalization, was achieved in 93.3 percent of cases, and procedural success — freedom from major adverse cardiovascular events — was achieved in more than 75 percent of cases, the company said.