The CHARITÉ® Artificial Disc the first and most clinically tested total disc replacement in the world. The FDA approved the CHARITÉ® Artificial Disc in October of 2004 after extensive review of the results of a two year U.S. clinical trial. In addition to this study, total disc replacement with the CHARITÉ® Artificial Disc has been performed in Europe for over 17 years and has been used in treating thousands of patients worldwide with successful results.
The CHARITÉ® Artificial Disc is comprised of proven orthopaedic materials; cobalt chromium Endplates and an Ultra-High Molecular Weight Polyethylene (UHMWPE) Sliding Core. Preclinical testing indicates that the unique mobile core design incorporates a floating center of rotation (FCOR), enabling independent translation & rotation, key components of physiologic motion. The mobile core moves dorsally during flexion and ventrally during extension.
The CHARITÉ® Artificial Disc System includes an extensive range of core heights, endplate sizes and endplate angles providing surgeons with numerous options to help ensure proper sizing, placement, and segmental lordosis. The CENTRELINE™ TDR Instrumentation aids in midline placement for optimal performance. Preclinical testing indicates that this system is designed to:
Maintain motion of the operative spinal segment
Maintain segmental stability
Restore proper disc height
Re-establish lordotic alignment
Reduce discogenic pain
The treatment of degenerative lumbar disc disease does not depend solely on the CHARITÉ® Artificial Disc. Other important considerations include:
Completion of a company-sponsored training program on use of the
CHARITÉ® Artificial Disc and CENTRELINE™ TDR Instruments
Proper patient selection
Safe and adequate surgical approach and exposure to the appropriate
degenerative disc level
Complete discectomy and meticulous endplate preparation
Optimal implant size, height and lordosis selection and proper placement
