European Union Expands CE Mark Approval

Vidacare Corporation’s EZ-IO Intraosseous Infusion System has received expanded EU CE mark approval for an extended dwell time of no greater than 72 hours for intraosseous (inside the bone) vascular access placements and for IO insertion in pediatric patients in the distal femur. These expanded CE mark approvals apply to the use of the EZ-IO System in participating European Union countries only and do not apply in the US.

Extended dwell times mean that intraosseous vascular access placements can remain in patients for up to but no more than 72 hours, allowing medical personnel additional time to use the IO route for vascular access. Previously, the maximum dwell time was 24 hours.

Expanded clearance to include distal femur insertions in pediatric patients allows physicians an additional site for consideration when assessing patients.

“The expanded CE mark approvals for the EZ-IO System in Europe allows clinicians additional opportunities to use the IO route to establish and maintain vascular access and enhance patient outcomes, and potentially reducing the use of more invasive central lines,” commented Michael Voss, Vidacare’s Chief Operating Officer.

Vidacare’s EZ-IO Intraosseous Infusion System, the market leader in IO technology, provides immediate vascular access for patients in multiple clinical settings, using the intraosseous (inside the bone) space. The EZ-IO is used by 90 percent of US advanced life support ambulances and over half of US Emergency Departments, as well as the US Military.

Established in 2001, Vidacare Corporation is the developer of a broad technology platform that is defining the field of intraosseous medicine. Current products include the EZ-IO Intraosseous Infusion System, the OnControl Bone Marrow System and the OnControl Bone Access System, and applications include vascular access, emergency and disaster medicine, oncology and spinal surgery. Vidacare’s focus on enhancing clinical efficacy, patient safety and comfort, and reducing complications and their associated costs, has resulted in its devices becoming the recognized technology standard. Privately held, the company is based in San Antonio, Texas, and its products are marketed in over 50 countries worldwide.

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