February 17, 2004
DePuy Spine, Inc., Files FDA Application For CHARITÉ® Artificial Disc
(RAYNHAM, Mass., February 17, 2004) -- DePuy Spine, Inc., a Johnson & Johnson company, reported Tuesday it has submitted a Premarket Approval Application (PMA) to the U.S. Food and Drug Administration (FDA) for review of its CHARITÉ® Artificial Disc.
The company's submission includes results of a 375-patient clinical study comparing implantation of the CHARITÉ® Artificial Disc to spinal fusion surgery for the treatment of degenerative disc disease.
"We believe the CHARITÉ® 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, Inc. "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 CHARITÉ® 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 CHARITÉ® 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, Inc. "The primary outcome results for the CHARITÉ® patients compared well with the results of patients within the clinical study's fusion control group."
The CHARITÉ® 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, Inc., acquired Link Spine Group and the CHARITÉ® Artificial Disc, including exclusive worldwide rights to the product, in May 2003.