Teleflex secures FDA 510(k) clearance for dialysis catheters

10 June 2013 (Last Updated June 10th, 2013 18:30)

Teleflex, a US-based firm that provides medical devices for critical care and surgery, has secured US FDA 510(k) clearance for its Arrow NextStep retrograde femoral length dialysis catheter.

Teleflex, a US-based firm that provides medical devices for critical care and surgery, has secured US FDA 510(k) clearance for its Arrow NextStep retrograde femoral length dialysis catheter.

The catheter adds to the company's existing NextStep hemodialysis catheter portfolio and is designed for ease of insertion and sustained high flow rates.

Teleflex Specialty Division president and general manager Linda Beneze said that the Arrow NextStep is the latest in a series of new product introductions that demonstrate the company's commitment to enhancing patient outcomes and improving ease of use for clinicians.

"We are proud to add the Arrow NextStep retrograde femoral length catheter to our portfolio," Beneze said.

"The catheter adds to the company's existing NextStep hemodialysis catheter portfolio and is designed for ease of insertion and sustained high flow rates."

The Arrow NextStep retrograde hemodialysis catheter is claimed to be the first of its kind to take better advantage of the blood flow dynamics within the heart through its reversed port configuration, where the venous port is located in the superior vena cava and the arterial port in the right atrium, resulting in minimised recirculation and high flow rates.

The NextStep Tip is meant for smooth, over-the-wire transitions during catheter insertions and exchanges.

In April, Teleflex's anesthesia and respiratory business division received 510(k) clearance for the ISO-Gard mask with ClearAir technology, a product that aims to reduce clinician exposure to hazardous waste anesthetic gases.

Headquartered in Limerick, Pennsylvania, Teleflax is a provider of specialty medical devices for several procedures in critical care and surgery.

It serves healthcare providers in more than 140 countries and employs 11,700 people internationally.