Teleflex Receives FDA Clearance for ARROW®JACC with Chlorag+ard® Technology and Tunneler
October 10 2016 - 6:45AM
Business Wire
Teleflex Incorporated (NYSE: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.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.
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. MC-002423
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Teleflex IncorporatedJake ElguiczeTreasurer and Vice President,
Investor Relations610-948-2836
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