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Devices FDA

 News Release - October 10, 2016

Teleflex Receives FDA Clearance for ARROW(R)JACC with Chlorag+ard(R) Technology and Tunneler

WAYNE, Pa.--(Healthcare Sales & Marketing Network)--Teleflex Incorporated (TFX), a leading global provider of medical devices for critical care and surgery, has announced it has received FDA 510(k) clearance to market its Arrow® JACC with Chlorag+ard® Technology and TightTrack™ tunneler.

Arrow JACC with Chlorag+ard Technology is a long-term, tunneled, small french size antithrombogenic1 and antimicrobial2 central venous catheter designed to meet the needs of patients throughout their course of therapy or illness. The catheter is also designed for use with high-pressure injection for diagnostic studies. The Arrow JACC with Chlorag+ard Technology protects against catheter occlusion3, phlebitis4, and intimal hyperplasia4 for up to 30 days. The Arrow JACC with Chlorag+ard Technology will enable caregivers to effectively and economically preserve vessel access, and care for millions of end stage renal disease patients.

“At Teleflex, we are committed to providing the right line for the right patient at the right time™,” said Jay White, President of the Vascular Division. “We are proud to add the tunneled Arrow JACC to our line of vascular access products. By providing an antithromogenic1 and antimicrobial2 catheter that protects against catheter occlusion3, we are offering a technology that no one else can. This is especially important in patients with end stage renal disease where vessel health and preservation is essential to provide a future dialysis vascular access5.”

About Teleflex Incorporated

Teleflex is a global provider of medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, surgical, anesthesia, cardiac care, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rusch® and Weck® – trusted brands united by a common sense of purpose.

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.

1.Data on file. AS compared to uncoated catheters, intravascular ovine model inoculated with Staph aureus. No correlation between in vitro/in vivo testing methods and clinical outcomes have currently been ascertained.

2.In vitro data on file 2010. No correlation between in vitro / in vivo testing methods and clinical outcomes have currently been ascertained.

3. Occlusion - As compared to uncoated PICCs, in vitro model measuring flush pressure post exposure to human blood. No correlation between in vitro / in vivo testing methods and clinical outcomes have currently been ascertained.

4. Phlebitis and Intimal Hyperplasia - As compared to uncoated PICCs, intravascular ovine model. No correlation between in vitro / in vivo testing methods and clinical outcomes have currently been ascertained.

5. KDOQI Guidelines 2006.

KDOQI is a trademark or registered trademark of the National Kidney Foundation, Inc.

Teleflex, Arrow, Chlorag+ard, and the right line, right patient, right time are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other counties. All other trademarks are trademarks of their respective owners.

© 2016 Teleflex Incorporated. All rights reserved.

Source: Teleflex

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.

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