FDAnews Device Daily Bulletin

ARTHROCARE RECEIVES FDA CLEARANCE FOR CARTRIDGE

April 3, 2006
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ArthroCare, a multi-business device company that develops minimally invasive surgical products, announced it received FDA clearance to market its Parallax Acrylic Resin Cartridge with TRACERS that works with the Parallax Integrated Delivery System (IDS).

The Parallax IDS is the industry's first fully enclosed device used to mix and deliver bone cement during vertebroplasty and kyphoplasty procedures, according to ArthroCare.

Vertebroplasty has been used for more than a decade in the U.S. to treat painful vertebral compression fractures, which can result from severe osteoporosis or benign (hemangioma) or malignant lesions (metastatic cancers, myleoma). It is estimated that more than 750,000 people per year suffer from vertebral compression fractures.