DePuy Spine’s Charite Artificial Disc for Replacement of Spinal Discs
October 26, 2004 by admin · Leave a Comment
On October 26, 2004 DePuy Spine Inc. announced that the FDA had approved the Charite™ Artificial Disc. The Charite Artificial Disc, a device made of two metallic endplates and a movable high-density plastic center, is the first FDA approved artificial replacement for spinal discs. The standard surgical intervention for this indication is lumbar fusion surgery which limits range of motion and may have consequences for discs above and below the fusion site. DePuy maintains that once implanted the Charite™ Artificial Disc is designed to help align the spine and preserve its ability to move. We have assigned this technology 90 points for innovation.
The burden of illness associated with low back pain in the United States is substantial. Back injuries have been the leading cause of disability in the United States in the under 45 age cohort and the most expensive health care problem for the 30 to 50-year-old age group. In 1995 low back pain accounted for almost a quarter or $8.8 billion of total workers’ compensation payments. Spinal fusion surgery, a common surgical treatment for low back pain or degenerative disc disease, is performed at least 200,000 times per year in the United States. This corresponds to a procedure incidence of 69/100 000 and a BioHorizon burden of illness score of 25.
In March 2004, clinical trial data comparing artificial disc replacement to spinal fusion surgery was presented at the 20th Annual Meeting of the AANS/CNS. DePuy indicated that patients treated with the Charite artificial disc maintained flexibility, experienced improvements in pain and function, and left the hospital sooner and were more satisfied with the procedure than spinal fusion treated patients. Data from this trial formed part of the Premarket Approval Application (PMA) submitted to the FDA earlier this year. Based upon FDA approval, we have scored the efficacy variable at 100.
Demand/Diffusion assessments around this emerging technology are problematic. Estimates by industry analysts span a range from between 100 million and 1 billion dollars per year. Competition from evolving minimally invasive fusion procedures may play a role. We currently score the demand/diffusion variable at 25.
The BioHorizon Emerging Health Technology Impact Score for the Charite artificial disc is currently 60, placing it in the Moderate/High Impact category. Health services delivery clients should commence preliminary assessment activities focusing on their spinal surgeons’ plans for integration of this disc replacement into practice.
Technology Details
Target Disease / Indication: Low Back Pain/Degenerative Disc Disease
Technology Classification: Device
Body System: Musculoskeletal
Program Area: Surgery/Orthopedics
Regulatory Status: Approved
BioHorizon Impact Score: 60/100-Moderate/High Impact