Healthcare Industry News:  Ampion 

Devices FDA

 News Release - October 17, 2016

Teleflex Receives FDA Clearance for the Arrow(R) Midline with Chlorag+ard(R) Technology

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® Midline with Chlorag+ard® Technology.

Arrow® Midline with Chlorag+ard® Technology is an antithrombogenic1 and antimicrobial2 peripheral venous catheter designed to minimize common midline catheter complications such as catheter intraluminal occlusion, thrombus accumulation and microbial colonization on the catheter surface for a minimum of 30 days.1,2,3 Additionally, the new midline is also designed for use with high-pressure injection for diagnostic studies. The Arrow® Midline with Chlorag+ard® Technology will enable caregivers to effectively and economically protect the catheter from potential costly complications.

“Clinicians are faced with a multitude of vascular access challenges. Development of new technology to ensure the patient receives the safest, most effective IV therapy possible should drive all medical device manufacturers. We at Teleflex continue to promote the message of ‘The Right Line for the Right Patient at the Right Time™.’ and through this belief we continue to develop products that help clinicians to chAmpion better care,” said Jay White, president and general manager of the Vascular Access Division of Teleflex. “The Arrow® Midline with Chlorag+ard® Technology continues to build upon this belief.”

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.com.

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.

Teleflex, the Teleflex logo, Arrow, Chlorag+ard, Deknatel, Hudson RCI, LMA, Pilling, Right Line, Right Patient, Right Time, Rusch and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates. © 2016 Teleflex Incorporated. All rights reserved. MC-002488

References

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.

Rx only

Contraindication:

The Arrow® PICC with Chlorag+ard® Technology is contraindicated for patients with known hypersensitivity to chlorhexidine.


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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