Centinel Spine has announced findings of a new study that it says strongly support the long-term safety and effectiveness of its prodisc L total disc replacement system for the lumbar spine.
The study is one of the largest total disc replacement patient groups ever evaluated—demonstrating the robust long-term clinical success of one- and two-level lumbar total disc replacement (TDR) with prodisc L, as assessed at 7-21 years postoperatively, according to Centinel Spine.
A total of 1,187 patients who underwent lumbar TDR from 1999 to 2013 were followed. According to the study, patients had maintained reduction in disability and pain scores over time, with low rates of index revision/reoperation or adjacent level surgery when compared to long-term published fusion data.
Total TDR revision and adjacent level surgery rates over 7-21 years were 0.67% and 1.85%, respectively.
Steve Murray, Centinel Spine CEO, said: “This study reinforces the long-term safety and effectiveness of the prodisc system, a motion preservation technology that supports the advancement of patient care.
“The prodisc technology was designed on proven design principles and this study demonstrates continued positive results after over 30 years of clinical usage.”
Centinel Spine is the only company with FDA-approved cervical and lumbar total disc replacement devices. The prodisc L remains the only total disc replacement system in the US approved for two-level use in the lumbar spine, says the firm.