FDA OK for ARROW GPSCath Balloon Dilatation

Teleflex Inc. officials announce that its subsidiary Hotspur Technologies Inc., which Teleflex acquired in June 2012, received FDA 510(k) clearance to market the company’s ARROW GPSCath Balloon Dilatation Catheters in Higher Rated Burst Pressure (RBP) and 80 cm lengths. These novel products 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 the first dual-functional balloon dilatation catheter that combines angioplasty and the proprietary VisioValve Injection System. This innovative combination enables physicians to perform high-pressure angioplasty and inject physician-specified fluids, such as contrast, all 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,” says 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.”