Teleflex today said it received FDA 510(k) clearance for expanded indications of its Arrow EZ-IO intraosseous vascular access system.
The device is designed to be used when intravenous access is difficult or impossible to obtain in emergent, urgent or medically necessary cases. The expanded indication allows the device to be used for up to 48 hours when alternate intravenous access is not available or established in adults and pediatric patients 12 years and older.
“Vascular access is one of the most basic, yet critical, components of patient care,” corporate VP and chief medical officer Michelle Fox said in a news release. “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.”
EZ-IO is cleared for use in the proximal humerus, proximal tibia and distal tibia in adults and distal femur, proximal humerus, proximal tibia and distal tibia in pediatrics aged 12 through 21 years old.
“We pursued this indication expansion with the FDA based on input from clinicians, who were seeking a longer dwell time,” VP and GM of anesthesia and emergency medicine Kevin Robinson said. “We are pleased to make this announcement now, allowing clinicians expanded options for managing patients with difficult vascular access.”