Teleflex Announces Expanded Indications for the Arrow® EZ-IO® Intraosseous Vascular Access System
October 01 2020 - 6:30AM
Teleflex Incorporated (NYSE: TFX), a leading global provider of
medical devices for critical care and surgery, has announced it has
received 510(k) clearance from the U.S. Food and Drug
Administration (FDA) to expand the Indications for Use of the
Arrow® EZ-IO® Intraosseous Vascular Access System. This device can
be used when intravenous access is difficult or impossible to
obtain in emergent, urgent, or medically necessary cases.
The Arrow® EZ-IO® System is now available with the expanded
indication stating use of the device may be extended for up to 48
hours when alternate intravenous access is not available or
reliably established in adults, and in pediatric patients 12 years
and older.
“Vascular access is one of the most basic, yet critical,
components of patient care,” said Michelle Fox, Corporate Vice
President and Chief Medical Officer, Teleflex. “The ability to use
the EZ-IO® System for a longer dwell time provides clinicians the
option to utilize intraosseous (IO) access for the entire duration
of therapy in patients with difficult vascular access where therapy
is required for up to 48 hours.”
In patients who require longer-term access, the expanded
indication gives clinicians additional time to establish vascular
access safely, choosing the appropriate device and optimal site of
insertion to meet the patient’s clinical needs. “These benefits are
of particular importance in a time of constrained resources and
patient surge,” said Ms. Fox.
Expanded Indications for Use of the
Arrow®
EZ-IO® 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 (≤21 years old) |
- Proximal humerus
- Proximal tibia
- Distal tibia
|
- Distal femur
- Proximal humerus
- Proximal tibia
- Distal tibia
|
Use of the device may be extended for up to 48 hours when
alternate intravenous access is not available or reliably
established.
Adults |
Pediatrics (≥12 years through 21 years old): |
- Proximal humerus
- Proximal tibia
- Distal tibia
|
- Distal femur
- Proximal humerus
- Proximal tibia
- Distal tibia
|
“We pursued this indication expansion with the FDA based on
input from clinicians, who were seeking a longer dwell time,” said
Kevin Robinson, Vice President and General Manager, Anesthesia and
Emergency Medicine Division, Teleflex. “We are pleased to make this
announcement now, allowing clinicians expanded options for managing
patients with difficult vascular access.”
About Teleflex IncorporatedTeleflex 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®, Rüsch® and Weck® – trusted brands united by a common
sense of purpose.
Forward-Looking StatementsAny 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, EZ-IO, Deknatel, Hudson RCI,
LMA, Pilling, Rüsch, and Weck are trademarks or registered
trademarks of Teleflex Incorporated or its affiliates, in the U.S.
and/or other countries.© 2020 Teleflex Incorporated. All rights
reserved. MC-006543
Source: Teleflex IncorporatedJake
ElguiczeTreasurer and Vice President, Investor
Relations610-948-2836
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