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Teleflex Announces FDA 510(k) Market Clearance of Its ArrowEVOLUTIONa" Pressure Injectable Peripherally Inserted Central Cathet


Published on 2010-09-07 09:41:08 - Market Wire
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LIMERICK, Pa.--([ BUSINESS WIRE ])--Teleflex Incorporated (NYSE:TFX) today announced that it has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for the companya™s ArrowEVOLUTIONa" PICC with Chlorag+arda" technology, a peripherally inserted central catheter with a Chlorhexedine-based solution that has been chemically-bonded into the surface of the catheter both intra- and extralumenally. Teleflex will launch the product for general availability in the United States in the fourth quarter.

"Market clearance from FDA for the ArrowEVOLUTION PICC with Chlorag+ard technology represents another significant milestone for Teleflex as we continue to provide innovative technologies to support healthcare providers who are working to improve patient outcomes through infection prevention"

"Market clearance from FDA for the ArrowEVOLUTION PICC with Chlorag+ard technology represents another significant milestone for Teleflex as we continue to provide innovative technologies to support healthcare providers who are working to improve patient outcomes through infection prevention,a commented Jeff Black, Teleflex Chairman and Chief Executive Officer. "We believe the ArrowEVOLUTION PICC with its anti-microbial coating will provide a technological advancement and unique option to clinicians in their efforts to protect against central line-associated bloodstream infections, a major contributor to hospital acquired infections.a

Through its Arrow brand, Teleflex is one of the leading global providers of vascular access technology with a commitment to helping healthcare providers in their efforts toward attaining and sustaining zero central line-associated bloodstream infections. The Arrow family of products also includes ARROWg+ard Blue PLUS® acute central venous catheters with a Chlorhexedine-based technology and Maximal Barrier Precautions Trays designed to support compliance with practice recommendations and guidelines.

About Teleflex Incorporated

Teleflex Incorporated (NYSE: TFX) 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 12,600 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 managementa™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.