Teleflex Announces the Arrow® EZ-IO® Needle Is Now FDA Cleared For Use in an MRI Environment
06 Junho 2023 - 7:30AM
Teleflex Incorporated (NYSE: TFX), a leading global provider of
medical devices for critical care and surgery, today announced that
the Arrow® EZ-IO® Needle is the first and only Intraosseous (IO)
Needle to receive 510(k) clearance from the U.S. Food and Drug
Administration (FDA) for MR Conditional labeling. The EZ-IO®
Needle, a critical component of the Arrow® EZ-IO® Intraosseous
Vascular Access System, has a patented diamond tip designed for
fast,1 precise and steady insertion.
The EZ-IO® System can be used when intravenous access is
difficult or impossible to obtain in emergent, urgent, or medically
necessary cases. The new labeling allows the clinician to
continuously care for patients who require MRI scans without
interruption to the established site for vascular
access.
“Clinical and Medical Affairs is committed to supporting the
expanded use of Teleflex medical devices in a continuous effort to
improve patient care,” said Michelle Fox, Corporate Vice President
and Chief Medical Officer, Teleflex. “Patients who require emergent
or urgent MRI now have an additional vascular access
option.”
“Teleflex continues to innovate on behalf of clinicians who are
seeking to provide continuous care during critical situations,”
said Kevin Robinson, President and General Manager, Anesthesia and
Emergency Medicine, Teleflex. “We are excited to have the Arrow®
EZ-IO® Needle cleared as MR Conditional and look forward to finding
new ways to deliver outstanding care solutions for patients and
providers.”
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 access, interventional
cardiology and radiology, anesthesia, emergency medicine, surgical,
urology 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®, LMA®, Pilling®,
QuikClot®, Rüsch®, UroLift® 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, LMA,
Pilling, QuikClot, Rüsch, UroLift, and Weck are trademarks or
registered trademarks of Teleflex Incorporated or its affiliates,
in the U.S. and/or other countries.© 2023 Teleflex Incorporated.
All rights reserved. MC-007250rev1
References: 1. Davidoff J, Fowler R, Gordon D,
et al. Clinical evaluation of a novel intraosseous device for
adults: prospective, 250-patient, multi-center trial. JEMS
2005;30(10):s20-3. Research sponsored by Teleflex Incorporated.
Contacts:Teleflex Incorporated:Lawrence
KeuschVice President, Investor Relations and Strategy
Development
investors.teleflex.com610-948-2836
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