Restated Indications for Use modify the weight range for the EZ-IO®
25 mm Needle Set for patients 3 kg or over
WAYNE, Pa.--(BUSINESS WIRE)--Mar. 17, 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 EZ-IO®
Vascular Access System. The EZ-IO® 25 mm Needle Set is now
indicated for patients 3 kg or over. Teleflex recently announced its
acquisition of Vidacare Corporation, developer of the EZ-IO®
Vascular Access System. Vidacare 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
serious conditions is paramount,” states Mark L. Waltzman, MD, FAAP,
Chief of Pediatrics, South Shore Hospital, Assistant Professor,
Department of Pediatrics at Harvard Medical School and affiliation with
the Division of Emergency Medicine at Boston Children’s Hospital. Dr.
Waltzman is also a paid consultant for Teleflex. “The restated
indication for the EZ-IO® 25 mm Needle Set to be used in
patients 3 kg or over will help to avoid confusion and streamline care.
Clinicians now will simply assess the tissue depth and choose the
correct needle size. This is something we ‘in the trenches’ clinicians
have requested from the company and I am gratified they have heard our
feedback and pushed for this change.”
New weight ranges for the EZ-IO® Vascular Access System are
now as follows:
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Description:
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Weight Classification
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EZ-IO® 45 mm Needle
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40 kg or over
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EZ-IO® 25 mm Needle
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3 kg or over
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EZ-IO® 15 mm Needle
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3 – 39 kg
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“As part of our fight for zero complications in vascular access, we are
committed to continuously improving our technologies, enhancing our
training and educational initiatives, and partnering with healthcare
professionals to provide innovative solutions for treating difficult
vascular access patients with the EZ-IO® Vascular Access
System,” states Jay White, President and General Manager, Vascular
Access Division, Teleflex. “We’re excited about the restated Indications
for Use, because we’ve made it even easier for clinicians to select the
right needle for their patient.”
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 11,400 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 and EZ-IO are trademarks or registered trademarks of
Teleflex Incorporated or its affiliates.
© 2014 Teleflex
Incorporated. All rights reserved. 2014-2900
Source: Teleflex Incorporated
Teleflex Incorporated
Jake Elguicze
Treasurer and Vice
President, Investor Relations
610-948-2836