Teleflex receives expanded indications for Arrow EZ-IO Intraosseous Vascular Access System

October 2, 2020  –  Teleflex Incorporated (Wayne, PA) 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.

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, the company says.

Expanded indications for use of the Arrow EZ-IO System now include “For intraosseous access anytime in which vascular access is difficult to obtain in emergent, urgent or medically necessary cases for up to 24 hours.”

Use of the device may be extended for up to 48 hours when alternate intravenous access is not available or reliably established.

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