FDA Clears Hotspur’s Balloon Dilation Catheter

Hotspur Technologies Inc., the Mountain View, Calif.-based subsidiary of critical care and surgical device company Teleflex Inc., has earned 510(k) clearance from the U.S. Food and Drug Administration for its Arrow GPSCath balloon dilation catheter in higher rated burst pressure (RBP) and 80 cm lengths. The product is designed to enable multiple vascular procedures to be performed with one dual-function catheter, potentially reducing procedure time and expense for both patients and medical professionals.

The Arrow GPSCath catheter is a dual-functional balloon dilatation catheter that combines angioplasty and Hotspur’s proprietary VisioValve injection system, intended to facilitate high-pressure angioplasty and the injection of physician-specified fluids, such as contrast, while maintaining the guidewire position.

“We are committed to enabling medical professionals to perform peripheral access procedures with devices that both simplify and improve the doctors’ and patients’ experiences,” said Benson Smith, chairman, president and CEO of Teleflex. “There are approximately 20 million patients with peripheral vascular disease who could benefit from this multi-purpose approach to catheter design, and we are excited to bring this innovative peripheral access product to market. The Arrow GPSCath balloon dilatation catheter with VisioValve technology is setting a higher bar for peripheral and dialysis access angioplasty performance.”

Hotspur makes catheter-based technologies aimed at restoring blood flow for patients with obstructed vessels.