Cardio Flow Granted FDA Clearance for Its FreedomFlow Peripheral Guidewire

Cardio Flow has received the FDA’s 510(k) clearance for its FreedomFlow guidewire, intended to treat peripheral artery disease.

The guidewire, which has a stainless-steel core with a silicone-coated distal-spring coil, was developed to support other diagnostic and therapeutic devices that treat plaque blockages in arteries both above and below the knee.

The guidewire features a silicone coating on the distal 200 centimeters that eases the crossing of difficult blockages. The 0.014-inch core-to-tip design provides better torque transmission and precise control when delivering therapeutic devices, the company said.

St. Paul, Minn.-based Cardio Flow specializes in minimally invasive vascular devices to treat peripheral artery disease.