Zacks_Analysts' Blog : FDA Clears ArthroCare Device - Analyst Blog

Surgical products maker ArthroCare Corp (ARTC) has received the U.S. Food and Drug Administration’s (FDA) approval for its Parallax Contour Vertebral Augmentation Device, designed for vertebral body void (or space) creation followed by injection of bone cement, a commonly used treatment for painful vertebral compression fractures (VCF).



The approval enables ArthroCare to market the Parallax Contour device for use during kyphoplasty or vertebral augmentation procedures. The device uses a movable, curved stylet (a wire run through a catheter) to displace soft bone and create a void in the vertebral body, which can be filled with Parallax Acrylic resin (bone cement). The cement augmentation is performed to strengthen and stabilize the vertebrae.



VCF is a condition characterized by the collapse of the vertebral bone. It may occur due to trauma or a weakened vertebra in patients with osteoporosis or metastatic cancer. Roughly 750,000 people in the U.S are estimated to suffer from VCF with more than 250,000 people undergoing spine augmentation procedures annually to alleviate pain associated with this condition.



Austin-based ArthroCare develops and markets minimally-invasive, state-of-the-art surgical products, addressing a multi-billion dollar market opportunity across several medical specialties. Many of the company’s products leverage its proprietary Coblation technology, which uses low-temperature radiofrequency energy to dissolve soft tissue (instead of burning it), thereby minimizing damage to healthy tissue.



ArthroCare markets its Coblation-based products through three business units, namely, Sports Medicine, ENT and Spine. The company offers its Parallax products (including needles, bone biopsy and bone cement products) through its Spinal division (6.5% of fiscal 2009 sales).



ArthroCare obtained the Parallax product line following its acquisition of Parallax Medical, a leading provider of VCF treatments, in 2004 for $28 million. The company expanded the Parallax product range in mid-2008 with the launch of the Parallax Contour device, which is used to mechanically displace soft bone in fractured vertebrae. The FDA approval of the Contour device for the new indication has broadened the addressable market for this novel device.
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