Teleflex Announces Restated Indications for Use for ARROW® EZ-IO® Vascular Access System

Now Approved for Pediatric Distal Femur Insertion

WAYNE, Pa.--()--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

Contacts

Teleflex Incorporated
Jake Elguicze
Treasurer and Vice President, Investor Relations
610-948-2836
jake.elguicze@teleflex.com
www.teleflex.com

Release Summary

Teleflex Announces Restated Indications for Use for Arrow EZ-IO Vascular Access System

Contacts

Teleflex Incorporated
Jake Elguicze
Treasurer and Vice President, Investor Relations
610-948-2836
jake.elguicze@teleflex.com
www.teleflex.com