Vertebroplasty, Kyphoplasty Receive FDA Clearance

Austin, TX - ArthroCare Corp. received notice from the U.S. Food and Drug Administration (FDA) that its Parallax Acrylic Resin with TRACERS-Ta Bone Cement Opacifier has been cleared for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures.

"The clearance of Tantalum opacified cement for use in vertebroplasty and kyphoplasty procedures further strengthens ArthroCare's position as a leading innovator in the treatment of spine diseases," said David Applegate, vice president and general manager of ArthroCare Spine.

Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myleoma). It is estimated that over 750,000 people a year are diagnosed with vertebral compression fractures (National Osteoporosis Society).

This product is designed to enhance the physician's ability to track the flow of bone cement under fluoroscopy and consists of premeasured Polymethyl-methacrylate (PMMA), Barium Sulfate and proprietary tantalum disk opacifiers. These particles create visible dark dots that clearly show cement flow and placement within the bone cavity, increasing patient and procedure safety.

"The addition of Tantalum as an opacifier in acrylic bone cement may improve the safety profile for patients undergoing vertebroplasty and kyphoplasty procedures. As the only tantalum opacifed cement approved for these procedures, Parallax Acrylic Resin with Tracers is important and extremely helpful for cases where imaging and visibility of the opacified cement is critical," stated Dr. Huy M. Do, Interventional Neuroradiologist, Associate Professor of Radiology and Neurosurgery, Stanford University Medical Center.

SOURCE: ArthroCare