RAYNHAM, Mass., Feb. 17 /PRNewswire-FirstCall/ -- DePuy Spine, Inc., a Johnson & Johnson company, today reported it has submitted a Premarket Approval Application (PMA) to the U.S. Food and Drug Administration (FDA) for review of its CHARITE(TM) Artificial Disc.
DePuy Spine’s submission includes results of a 375-patient clinical study comparing implantation of the CHARITE Artificial Disc to spinal fusion surgery for the treatment of degenerative disc disease.
We believe the CHARITE Artificial Disc’s motion preservation technology has the potential to transform the treatment of spine disorders in the United States,” said Earl R. Fender, Worldwide President, DePuy Spine. “We also believe this first-ever submission for a total disc replacement device represents what could be the beginning of a promising era of new treatment of physiologically desirable options for degenerative disc disease.”
The CHARITE Artificial Disc has been used to treat more than 6,500 patients over the past 15 years in 30 countries outside the United States. FDA approval of the CHARITE Artificial Disc would provide doctors and patients an alternative to spinal fusion surgery*, which is performed on more than 300,000 people each year in the United States.
“We are pleased with the contents of the submission and feel that the data soundly supports the study hypothesis for outcome equivalency,” said Bill Christianson, Vice President, Clinical & Regulatory Affairs, DePuy Spine. “The primary outcome results for the CHARITE patients compared well with the results of patients within the clinical study’s fusion control group.”
The CHARITE Artificial Disc is made of two metallic endplates and a polyethylene core that articulates between them and has been the subject of clinical trials at 15 centers throughout the United States. DePuy Spine acquired Link Spine Group and the CHARITE Artificial Disc, including exclusive worldwide rights to the product, in May 2003.
About DePuy Spine, Inc.
DePuy Spine, a Johnson & Johnson company, has partnered with leading clinicians, researchers, and thought leaders to develop products to treat spine disorders for over 20 years. Today, DePuy Spine stands in the forefront of the worldwide spine market, with a substantial sales organization in the U.S. and an expanding worldwide distribution network. The company is committed to advancing the knowledge of all healthcare professionals and their patients in addressing spinal pathologies.
* Spinal fusion is a technique in which one or more unstable spinal vertebrae on the spine are immobilized, using bone graft material. While this may help reduce or stop back pain, spinal fusion limits the patient’s range of motion and may unnaturally stress the adjacent anatomy.
DePuy Spine, Inc.
CONTACT: Press: David Swearingen, +1-732-562-3132, or Investor: Helen E.Short, +1-732-524-6491, or Stan Panasewicz, +1-732-524-2524, all for DePuySpine, Inc.
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