Teleflex, a US-based provider of medical devices for critical care and surgery, has received the US Food and Drug Administration (FDA) 510(k) approval for its Arrow EZ-IO Needle.
According to the company, Arrow is the first and only Intraosseous (IO) Needle to receive FDA approval for MR Conditional labelling.
The EZ-IO Needle is a key component of its Arrow EZ-IO Intraosseous Vascular Access System, with a patented diamond tip designed for rapid, precise and steady insertion.
The system can be used in emergent, urgent, or medically necessary cases, when obtaining intravenous access is difficult or impossible.
The new FDA approval allows the clinician to continuously care for patients who need MRI scans without interruption to the established site for vascular access, said the company.
Teleflex corporate vice president and chief medical officer Michelle Fox said: “Clinical and Medical Affairs is committed to supporting the expanded use of Teleflex medical devices in a continuous effort to improve patient care.
Teleflex anaesthesia and emergency medicine president and general manager Kevin Robinson said: “Teleflex continues to innovate on behalf of clinicians who are seeking to provide continuous care during critical situations.
“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.”
Teleflex provides medical devices in the fields of vascular access, interventional cardiology and radiology, anaesthesia, emergency medicine, surgical, urology and respiratory care.
Last month, the company rolled out two new Arrow family of medical devices to improve peripherally inserted central catheter (PICC) insertion procedures.
The new devices, Arrow VPS Rhythm DLX Device and NaviCurve Stylet, are designed to enable effective and predictable PICC placement, while reducing the risk of complications.
According to the company, the new-generation VPS Rhythm DLX Device provides real-time catheter tip location information using the patient’s cardiac electrical activity.
It works with the Arrow PICC, preloaded with the NaviCurve Stylet, to provide advanced tip navigation technology, said the medical device maker.
