Now Approved for Pediatric Distal Femur Insertion
WAYNE, Pa.--(BUSINESS WIRE)--Sep. 8, 2014--
Teleflex Incorporated (NYSE: TFX), a leading global provider of medical
devices for critical care and surgery, has announced FDA 510(k)
clearance for restated Indications for Use of the Arrow® EZ-IO®
Vascular Access System.
The EZ-IO® Vascular Access System is now indicated to include
the distal femur for pediatric patients. Teleflex acquired Vidacare
Corporation (Vidacare LLC) in December 2013. As the manufacturer of the
EZ-IO Vascular Access System, Vidacare LLC is a leading provider of
intraosseous (IO), or inside the bone, access devices.
“In my clinical work in a free-standing, academic pediatric emergency
department and Level 1 trauma center, as well as in a large community
hospital emergency department, rapid identification and treatment of
pediatric patients with difficult vascular access is paramount,” said
Mark L. Waltzman, MD, FAAP, Chief of Pediatrics, South Shore Hospital,
Assistant Professor, Department of Pediatrics at Harvard Medical School
and an attending physician with the Division of Emergency Medicine at
Boston Children’s Hospital. Dr. Waltzman is a paid consultant for
Vidacare LLC.
Added Dr. Waltzman, “The restated indication for the EZ-IO®
Vascular Access System that allows distal femur insertion in pediatric
patients helps streamline care for healthcare professionals when time is
critical. We, in the medical community, believe that the distal femur is
a viable location for pediatric intraosseous access and I am grateful
Teleflex has heard our feedback on this matter and pushed for this
change.”
Restated Indications for Use of the EZ-IO®
Vascular Access System are now as follows:
For intraosseous access anytime in which vascular access is difficult to
obtain in emergent, urgent or medically necessary cases for up to 24
hours.
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Adults
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Pediatrics
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-- Distal femur (NEW)
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-- Proximal humerus
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-- Proximal humerus
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-- Proximal tibia
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-- Proximal tibia
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-- Distal tibia
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-- Distal tibia
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“We pursued this indication expansion based on input from our clinicians
and we are excited about its clearance, allowing clinicians expanded
options for pediatric vascular access in appropriate clinical
situations,” said Jay White, President and General Manager, Vascular
Access Division, Teleflex.
About Teleflex Incorporated
Teleflex is a leading global provider of specialty medical devices for a
range of procedures in critical care and surgery. Our mission is to
provide solutions that enable healthcare providers to improve outcomes
and enhance patient and provider safety. Headquartered in Wayne, PA,
Teleflex employs approximately 11,500 people worldwide and serves
healthcare providers in more than 150 countries. Additional information
about Teleflex can be obtained from the company's website at 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.
Teleflex, Arrow, EZ-IO and Vidacare are trademarks or registered
trademarks of Teleflex Incorporated or its affiliates.
© 2014 Teleflex Incorporated. All rights reserved. MC-000313
Source: Teleflex Incorporated
Teleflex Incorporated
Jake Elguicze
Treasurer and Vice
President, Investor Relations
610-948-2836
jake.elguicze@teleflex.com
www.teleflex.com