FDA says yes to Teleflex’s new Arrow GPSCath balloon dilatation catheters


Teleflex has announced that it has received given 510(k) clearance for its Arrow GPSCath balloon dilatation catheters in higher rated burst pressure and 80cm lengths. These new 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.

According to a company press release, the Arrow GPSCath catheter is the first dual-functional balloon dilatation catheter that combines angioplasty and the proprietary VisioValve injection system. It reported that this combination enables physicians to perform high-pressure angioplasty and inject physician-specified fluids, such as contrast, all while maintaining the guidewire position.

Benson Smith, chairman, president and chief executive officer of Teleflex, said: “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.”