BALEX Bone Expander System - Kyphoplasty balloon catheterDefinition: A sterile, flexible tube designed to be used for the creation of a void within a vertebral body during a minimally invasive procedure commonly known as balloon kyphoplasty. It is manually inserted percutaneously through an access channel under fluoroscopic guidance to a vertebral compression fracture (VCF) site (e.g., in the lumbar or thoracic region of the spine) where its balloon is inflated with a medium (e.g., a liquid contrast medium) to force the vertebrae apart for insertion of bone cement;thereafter it is deflated and removed via the access channel. This is a single-use device.
2026-05-11