FDA grants ArthroCare marketing clearance for Parallax Contour Vertebral Augmentation Device

Sep 24 2010

ArthroCare Corp. (NASDAQ: ARTC), a leader in developing state-of-the-art, minimally invasive surgical products, announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its Parallax^® Contour^® Vertebral Augmentation Device (Contour) specifically for void creation in a vertebral body followed by injection of bone cement. Vertebral body void creation followed by bone cement augmentation is commonly used to treat painful vertebral compression fractures.

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). Pathological vertebral body compression fractures may result from osteoporosis, benign or malignant lesions such as metastatic cancers and myeloma.

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.