The History of ProDisc-L Total Disc Replacement
The ProDisc concept was developed in the late 1980’s by Dr. Thierry Marnay, a French orthopedic surgeon. In early 1990, Dr. Marnay and one other surgeon started implanting a series of ProDisc implants in the lumbar spine. A total of 64 patients were implanted between 1990 and 1993.
A retrospective analysis of 58 of the original 64 patients showed the following results 7 to 11 years post-operatively:
- Significant decrease in:
- Low back pain
- Lower limb pain
- Impairment scale
- All implants were intact
- Ninety-one percent (91%) of the patients report they were entirely satisfied or satisfied with the procedure
- There was no evidence of osteolysis (degeneration of bone tissue)
Based on the long term results of this 7-11 year study, the ProDisc-L total disc replacement was launched in Europe and has been in clinical use there since 1999. In the United States, an IDE study was initiated and the first procedure was performed in October 2001. Most recently, the ProDisc-L total disc replacement was approved for use in the United States based on the results of this prospective, randomized, multi-center clinical trial of the investigational device (IDE study).