ArthroCare’s Parallax Acrylic Resin Receives FDA Clearance For Vertebroplasty And Kyphoplasty

rthroCare(R) Corp. (Nasdaq:ARTC), a multi-business medical device company that develops minimally invasive surgical products, received notice from the U.S. Food and Drug Administration (FDA) today that its Parallax(R) Acrylic Resin with TRACERS(R) Bone Cement Opacifier has been cleared for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myleoma).

“While this development will not have any material impact on fourth quarter financials, it is a significant milestone for the company,” said Michael Baker, president and chief executive officer of ArthroCare. “This 510(k) clearance positions us well going into 2005 to be a strong competitor in the fast-growing vertebroplasty and kyphoplasty market segments.”

The FDA clearance also coincides with ArthroCare’s launch of a new version of its Parallax Acrylic Resin featuring a proprietary type of tantalum. This product, currently cleared for use in cranioplasty, is designed to enhance the physician’s ability to track the flow of bone cement under fluoroscopy. ArthroCare intends to seek 510(k) clearance for use of the tantalum opacified cement in vertebroplasty or kyphoplasty procedures during the first quarter of 2005.