Teleflex Announces FDA Clearance to Market Arrow NextStep Antegrade Catheter for Chronic Hemodialysis

LIMERICK, Pa.--()--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.

“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.

About Teleflex Incorporated

Teleflex Incorporated is a global provider of medical technology products that enable healthcare providers to improve patient outcomes, protect against infections and support patient and provider safety. Teleflex, which employs approximately 12,500 people worldwide, also has niche businesses that serve segments of the aerospace and commercial markets with specialty engineered products. Additional information about Teleflex can be obtained from the company’s website at www.teleflex.com.

Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management’s current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. These risks and uncertainties are identified and described in more detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K.

Contacts

Teleflex Incorporated
Jake Elguicze
Vice President Investor Relations
610-948-2836

Contacts

Teleflex Incorporated
Jake Elguicze
Vice President Investor Relations
610-948-2836