- The study is one of the largest single-site total disc patient groups ever evaluated
- The study expands the evidence of prodisc L with results up to 21 years across a large patient cohort
- prodisc L is the only total disc replacement system in the U.S. approved for two-level use in the lumbar spine
- Centinel Spine is the only company with FDA-approved cervical and lumbar total disc replacement devices
West Chester, PA, August 31, 2021 – Centinel Spine®, LLC, a leading global medical device company addressing cervical and lumbar spinal disease through anterior surgical access, today announced findings of a new study first presented at the annual meeting of the International Society for the Advancement of Spinal Surgery (ISASS) (May 13-15, 2021, Miami, FL). Thierry Marnay, MD reported results that strongly support the long-term safety and effectiveness of Centinel Spine’s prodisc L Total Disc Replacement System for the lumbar spine. Results from this study will be further presented during the Best Paper session at the upcoming North American Spine Society (NASS) 36th Annual Meeting on Thursday, September 30, 2021.
The study expands the evidence of prodisc L and 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. A total of 1,187 patients who underwent lumbar TDR from 1999 to 2013 were followed. Until this study, lumbar TDR published evidence was limited to 5-7 year follow up.
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 (Marnay, Thierry. “7 to 21 year clinical outcomes of 1,187 patients treated with one and two level lumbar total disc arthroplasty”, ISASS 2021 Annual Meeting, May 14, 2021, Miami, FL).
ACCORDING TO STEVE MURRAY,
CEO, Centinel Spine:
“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 continues to lead the total disc replacement market and 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 U.S. approved for two-level use in the lumbar spine.
About Centinel Spine, LLC
Centinel Spine®, LLC is a leading global medical device company addressing cervical and lumbar spinal disease through anterior surgical access. The company offers a continuum of trusted, brand-name, motion-preserving and fusion solutions backed by over 30 years of clinical success—providing the most robust and clinically-proven technology platforms in the world for total disc replacement (prodisc®) and Integrated Interbody™ fusion (STALIF®).
Centinel Spine continues to advance its pioneering culture and corporate mission to become a catalyst of change in the spine industry and alter the way spine surgery is perceived. Centinel Spine remains the only company with comprehensive motion-preserving and fusion solutions for both cervical and lumbar anterior column reconstruction.
For more information, please visit the company’s website at www.CentinelSpine.com or contact:
Chief Financial Officer
900 Airport Road, Suite 3B
West Chester, PA 19380