Teleflex Announces the Arrow® EZ-IO® Needle Is Now FDA Cleared For Use in an MRI Environment
First and Only IO Needle with MR Conditional Safety Status Labeling
WAYNE, Pa., June 06, 2023 (GLOBE NEWSWIRE) -- 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 Incorporated
Teleflex 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 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, 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 Keusch
Vice President, Investor Relations and Strategy Development
investors.teleflex.com
610-948-2836
