Teleflex Announces Restated Indications for Use for ARROW® EZ-IO® Vascular Access System
September 08 2014 - 7:00AM
Business Wire
Now Approved for Pediatric Distal Femur
Insertion
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.
Adults
Pediatrics
-- Distal femur (NEW)
-- Proximal humerus
-- Proximal humerus
-- Proximal tibia
-- Proximal tibia
-- Distal tibia
-- Distal tibia
“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
Teleflex IncorporatedJake ElguiczeTreasurer and Vice President,
Investor
Relations610-948-2836jake.elguicze@teleflex.comwww.teleflex.com
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