Teleflex subsidiary receives 510(k) clearance for balloon dilatation catheters

30 July 2013 (Last Updated July 30th, 2013 18:30)

US-based Teleflex’s subsidiary Hotspur Technologies has received US regulatory clearance to market its ARROW GPSCath balloon dilatation catheters in higher rated burst pressure (RBP) and 80cm in length.

US-based Teleflex's subsidiary Hotspur Technologies has received US regulatory clearance to market its ARROW GPSCath balloon dilatation catheters in higher rated burst pressure (RBP) and 80cm in length.

The device would allow multiple vascular procedures to be performed with one dual-function balloon dilatation catheter, which in turn minimises the procedure time and costs for both patients and hospitals.

The dual functional balloon dilatation catheter in combination with VisioValve injection system allows surgeons to perform high-pressure angioplasty and inject specified fluids such as contrast, while simultaneously maintaining the guidewire position too.

"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."

Teleflex chairman president and CEO Benson Smith said the company was committed to enabling medical professionals to perform peripheral access procedures with devices that both simplify and improve the doctors' and patients' experiences.

"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," Smith said.

"The ARROW GPSCath balloon dilatation catheter with VisioValve technology is setting a higher bar for peripheral and dialysis access angioplasty performance."

In June 2012, Teleflex acquired Hotspur Technologies, a provider of catheter-based technologies for restoring blood flow in patients with obstructed vessels, in a deal worth $15m.

Last month, Teleflex received 510(k) clearance for its Arrow NextStep retrograde femoral length dialysis catheter, designed for ease of insertion and sustained high flow rates.