Hotspur Technologies, a subsidiary of US-based Teleflex, has secured FDA 510(k) clearance to market its ARROW GPSCath Balloon Dilatation Catheters in higher rated burst pressure (RBP) and 80 cm lengths.
These products allow several vascular procedures to be performed with one dual-function catheter, thereby minimizing the procedure time and expense for patients as well as for medical professionals.
As dual-functional balloon dilatation catheter, it combines angioplasty and VisioValve Injection System, allowing surgeons to perform high-pressure angioplasty and inject physician-specified fluids, such as contrast, whilst maintaining the guidewire position.
Teleflex, chairman, president and CEO Benson Smith noted that the company is 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.
"The ARROW® GPSCath® Balloon Dilatation Catheter with VisioValve™ Technology is setting a higher bar for peripheral and dialysis access angioplasty performance," Smith added.