FDA grants marketing clearance for Teleflex Arrow NextStep Antegrade Chronic Hemodialysis Catheter

Teleflex Incorporated (NYSE:TFX), a global provider of medical technology products, announced today that its Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheter has received market clearance from the U.S. Food and Drug Administration (FDA). The NextStep Antegrade Chronic Hemodialysis Catheter is designed to attain long-term vascular access for hemodialysis and apheresis. It is indicated for use in adult patients. Teleflex expects to launch the product in the United States later this year.

“We are confident that it will become a preferred option for clinicians who use the antegrade tunneling procedure to insert chronic hemodialysis catheters.”

"The Arrow NextStep Antegrade Catheter is designed to provide some of the benefits of step-tip and split-tip catheters in a single solution," said Benson Smith, Teleflex Chairman, President and CEO. "We are confident that it will become a preferred option for clinicians who use the antegrade tunneling procedure to insert chronic hemodialysis catheters."

The Arrow NextStep Antegrade Chronic Hemodialysis Catheter includes a step-tip catheter's ease of insertion and a split-tip catheter's sustained high flow. Compared to traditional chronic hemodialysis catheters, the ports are reversed to match the heart's natural blood flow dynamics. The venous port releases blood into the superior vena cava. The arterial port draws blood from the right atrium. Side holes on the tip of the catheter are designed to pull blood from all sides of the catheter. The ports are significantly separated to enhance flow and minimize recirculation.

The Arrow family of vascular access products includes the ARROWg+ard Blue PLUS^® central venous catheters with a Chlorhexidine-based technology, the recently introduced Arrow EVOLUTION™ PICC with Chlorag+ard™ antimicrobial technology and the NextStep Retrograde, NextStep Antegrade, Edge and Cannon II Plus chronic hemodialysis catheter product lines. Arrow central venous access catheters, peripherally inserted central catheters, multi access catheters and acute hemodialysis catheters are now available in ErgoPack Maximal Barrier Precautions Trays, a system designed to support compliance with best practice and guidelines for catheter insertion.

Teleflex also recently expanded its vascular access product offerings with the acquisition of the VasoNova VPS vascular positioning system, a central venous catheter tip navigation system.