Hotspur Technologies, a subsidiary of Teleflex, has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for the Arrow GPSCath PTA balloon dilatation catheters designed for use with .014” guide wires and in 150cm length.
Combining angioplasty with the proprietary VisioValve injection system, the Arrow GPSCath dual functional balloon dilatation catheter enables clinicians to perform peripheral below the knee angioplasty and inject physician selected fluids, such as contrast media, while maintaining guide wire position.
Teleflex president and CEO Benson Smith said: "With this latest product approval we continue our commitment to enabling medical professionals to perform peripheral access procedures that simplify and improve the doctor and patient experience while reducing health care costs.
"We are excited to bring this innovative product for use in below the knee peripheral interventions to the market."
The company claims that the device enables a variety of peripheral vascular procedures to be performed below the knee with one dual function catheter, potentially reducing procedure time, radiation dosage, and expense for both patients and medical professionals.