FDA Clearance for Teleflex ARROW® GPSCath® Balloon Dilatation Catheters in Higher RBP and 80 cm Lengths

Back in June, Teleflex, Inc., saw its Arrow® GPSCath® Balloon Dilatation Catheter CE marked. Now the company tells us it has received U.S. FDA 510(k) clearance to market the devices in Higher Rated Burst Pressure (RBP) and 80 cm lengths.

Background 

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.

Teleflex claims 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 announcement follows the company’s release of quarterly financial data showing 10% year on year revenue growth.

Company comments

“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. Added Smith, “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.”

Source: Teleflex, Inc., Business wire