GlobeNewswire Inc | Oct 1, 2020 06:30AM EDT

October 01, 2020

WAYNE, Pa., Oct. 01, 2020 (GLOBE NEWSWIRE) -- 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 patients 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 ArrowEZ-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 * Distal femur * Proximal tibia * Proximal humerus * Distal tibia * 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 * Distal femur * Proximal tibia * Proximal humerus * Distal tibia * 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 peoples 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, Rsch 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, Rsch, 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