FDA clears ArthroCare's Parallax Contour-enhanced Vertebral Augmentation Device

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 second-generation Parallax® Contour® -enhanced Vertebral Augmentation Device specifically for void creation in a vertebral body followed by injection of bone cement. Vertebral augmentation, also referred to as vertebroplasty or kyphoplasty, is commonly used to treat painful vertebral compression fractures. This new lower profile device makes it easier for surgeons to operate in tight spaces and to provide additional tactile and audible feedback to improve ease of use during the void creation process.

The Contour-enhanced utilizes a curved, movable stylet to displace cancellous bone within vertebrae, creating a void. This void is then filled with bone cement to stabilize the fracture. The Contour-enhanced is indicated for 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.



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