ArthroCare Corp has received clearance from the U.S. Food and Drug Administration (FDA) to market its Parallax Contour Vertebral Augmentation Device (Contour).
Contour creates a void in a vertebral body, which is then followed by an injection of bone cement. Vertebral body void creation followed by bone cement augmentation is commonly used to treat painful vertebral compression fractures.
Contour, previously marketed as an osteotome, uses a movable, curved stylet to displace bone. By displacing bone, a void is created which can be filled with the injection of Parallax bone cement. Contour utilizes a small access needle and is manually advanced and rotated to create the space.
Pathological vertebral body compression fractures may result from osteoporosis, benign or malignant lesions such as metastatic cancers and myeloma.
The newly cleared Indication Statement provides that the Contour device is indicated for use during kyphoplasty or vertebral augmentation procedures to create a void in the vertebral body and fill the void with Parallax Acrylic resin (bone cement).
(Source: Press Release)