Teleflex Reports Restated Indications For Arrow EZ-IO Vascular Access SystemA

(RTTNews) - Teleflex Inc. (TFX), a 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 currently indicated to include the distal femur for pediatric patients. Teleflex acquired Vidacare Corp. in December 2013. As the manufacturer of the EZ-IO Vascular Access System, Vidacare LLC is a provider of intraosseous, 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 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. Waltzman is a paid consultant for Vidacare LLC.

He added, "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."