US FDA clears Stryker’s AVAflex balloon system

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Stryker has received US Food and Drug Administration (FDA) 510(k) clearance for its AVAflex balloon system. The device is available with Stryker’s bone cements and implants and the AutoPlex mixing and delivery system.

Chad Ludwig, marketing director at Stryker Instruments, says, “The AVAflex balloon system enables doctors to achieve bipedicular results with a unipedicular approach to vertebral augmentation.”

The AVAflex curved balloon system’s new 11-gauge size is designed to allow surgeons to achieve with one insertion and a smaller needle what had previously required two insertions, making procedures less invasive and potentially reducing the risk of patient trauma. Using a minimally invasive technique, physicians should be able to successfully create a midline cavity for targeted cement placement by accessing one pedicle.

AVAflex is now available with Stryker’s bone cements and implants and the AutoPlex mixer and delivery system, which is intended to provide consistent and thorough blending of components, helping eliminate human error and variability.