Teleflex Incorporated (TFX) revealed the receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) for restated Indications for use of the Arrow EZ-IO Vascular Access System. The restated indication for the EZ-IO Vascular Access System allows distal femur insertion in pediatric patients.
Distal femur fractures are cracks or breakage in the thighbone that occur just above the knee joint. Such fractures usually occur either in elderly people with weak bones or in children who suffer high energy injuries, resulting either from sports or vehicular trauma.
Medical practitioners believe that the distal femur is a viable location for intraosseous (inside the bone) access in pediatric patients. According to them, rapid identification and treatment of pediatric patients with difficult vascular access is very important across all settings. Based on such inputs from clinicians, Teleflex pursued the indication expansion for its vascular system.
EZ-IO Vascular Access System, now approved for pediatric distal femur insertion, helps streamline care for healthcare professionals when vascular access is difficult to obtain in urgent or medically necessary cases.
EZ-IO Vascular Access System has been developed by Vidacare Corporation – a leading provider of intraosseous access devices, which was acquired by Teleflex in December last year.
In March this year, Teleflex received FDA clearance for another restated Indication for use of the EZ-IO Vascular Access System. The restated indication helps clinicians assess the tissue depth and select the correct needle size for treating patients, thus avoiding confusion and streamlining care.
In keeping with its efforts to simplify vascular access, Teleflex is consistently improving its technologies for enhancing treatment procedures with the EZ-IO Vascular Access System.
Currently, Teleflex carries a Zacks Rank #2 (Buy). Other well-performing medical instrument stocks include Alphatec Holdings, Inc. (ATEC), ERBA Diagnostics, Inc. (ERB) and RTI Surgical Inc. (RTIX). All these stocks sport a Zacks Rank #1 (Strong Buy).
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