Teleflex announces US FDA clearance of Arrow EZ-IO Needle for use with MRI

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teleflex featuredTeleflex has announced in a press release that the Arrow EZ-IO Needle is the first and only intraosseous (IO) needle to receive 510(k) clearance from the US Food and Drug Administration (FDA) for magnetic resonance (MR) conditional labelling. The EZ-IO Needle, a critical component of the Arrow EZ-IO intraosseous vascular access system, has a patented diamond tip designed for fast, 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 labelling allows the clinician to care continuously for patients who require magnetic resonance imaging (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, Anaesthesia 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.”

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