FDA clears 150cm length Arrow GPSCath balloon dilatation catheters


Teleflex Incorporated has announced that its subsidiary Hotspur Technologies received FDA 510(k) clearance to market the Arrow GPSCath balloon dilatation catheters designed for use with .014” guide wires and in 150cm length.

These novel products enable 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.

The Arrow GPSCath balloon dilatation catheter is the first dual functional balloon dilatation catheter that combines angioplasty with the proprietary VisioValve injection system. This innovative combination enables physicians to perform peripheral below-the-knee angioplasty and inject physician selected fluids, such as contrast media, while maintaining guide wire position.

“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,” says Benson Smith, chairman, president and chief executive officer of Teleflex. Smith adds, “We are excited to bring this innovative product for use in below-the-knee peripheral interventions to the market.”