- 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.
- The prodisc® technology is the most studied and clinically-proven TDR system in the world, validated after 30 years of clinical use and by over 540 published papers.*
West Chester, PA, October 11, 2022 – 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 to be presented during the North American Spine Society (NASS) 37th Annual Meeting on Thursday, October 13, 2022. Thierry Marnay, MD will present results from the study that support long-term mobility superiority of Centinel Spine’s prodisc® L Lumbar Total Disc Replacement (TDR) device compared to two-level hybrid reconstruction.**
The study expands the evidence validating the clinical efficacy of prodisc L and is one of the first long-term mobility comparisons between two-level lumbar TDR and hybrid constructs consisting of one-level lumbar TDR combined with one-level anterior lumbar interbody fusion (ALIF). A total of 235 patients who underwent lumbar surgery from 2003 to 2013 were followed—consisting of 170 patients receiving L4-S1 two-level lumbar TDR and 65 patients receiving L5-S1 fusion and L4-L5 TDR hybrid construct.
According to the study, after a minimum of 24 months follow-up, the two-level prodisc L TDR demonstrates superiority in absolute lumbar mobility and pelvic motion. The hybrid construct demonstrates an overall lack of compensation in lumbar mobility and pelvic motion as compared to the two-level lumbar TDR. Although measures of activity and pain were equivalent between the study groups, the two-level TDR also demonstrated functional superiority versus the hybrid construct (Marnay, Thierry. “Mobility Parameters in Two-Level Lumbar TDR vs Hybrid Construct: Clinical Results in 235 Patients”, NASS 2022 Annual Meeting, Thursday, October 13, 2022, Chicago, Illinois).
ACCORDING TO STEVE MURRAY
CEO, Centinel Spine:
“This study further reinforces the long-term effectiveness of the prodisc system, a proven technology that supports the advancement of patient care. The system was engineered with proven design principles, and this is another study that demonstrates continued positive results of prodisc L after over 30 years of clinical use.”
The prodisc L Lumbar TDR system, along with the newly-approved prodisc cervical TDR portfolio that allows the disc to be matched to patient anatomy, will be featured at the Centinel Spine booth (#4224) during NASS 2022.
* Search performed on Pubmed, Embase, Ovid Medline® covering 1988 – 2021.
** prodisc L is indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease at one or two contiguous intervertebral level(s) from L3-S1. Please refer to the prodisc IFU012, Rev 2 04/20 for the complete indications, contraindications, and precautions for prodisc L. The safety and effectiveness of the prodisc L has not been established in patients using a hybrid (TDR/ALIF) implant construct.
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