FDAnews
www.fdanews.com/articles/74361-fda-clears-arthrocare-product

FDA CLEARS ARTHROCARE PRODUCT

July 15, 2005

The FDA has cleared ArthroCare's Parallax Acrylic Resin with TRACERS-TA Bone Cement Opacifier for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures.

The product is designed to enhance the physician's ability to track the flow of bone cement under fluoroscopy and consists of premeasured polymethyl methacrylate, barium sulfate and 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 opacified 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.

Along with its other bone cement products, ArthroCare's Parallax Acrylic Resin with TRACERS-TA provides advantages for increasing procedure flexibility including: a 12 to 15 minute work time; an all-in-one package; and optimum opacification without altering compression strength.