Landmark Lumbar Total Disc Replacement Study of Nearly 1,200 Patients Supports Long-term Clinical Success and Durability of Centinel Spine's prodisc® L System

• Posted electronically prior to print publication by The Journal of Bone & Joint Surgery, the retrospective study assesses one of the largest evaluated cohorts of patients who underwent lumbar total disc replacement (LTDR), demonstrating the robust long-term clinical success of the prodisc L LTDR system.¹
  
  
• This study expands the evidence validating the fixed-core design of the prodisc L device and includes 1,187 patients undergoing 1- or 2-level LTDR, with and without prior surgery, and followed from 7 to 21 years (mean of 11 years and 8 months).
  
  
• The study results demonstrate extremely low long-term rates of index-level revision (0.67%) and adjacent-level surgery (1.85%), while showing statistically equivalent outcomes for 1-level LTDR, 2-level LTDR, and for patients with and without prior surgery.
  
  
• After almost 35 years of proven, durable clinical success, prodisc L now includes FDA approvals for one-level indications, two-level indications and, most recently, for the Anatomic Endplate^™ versions of the system.

WEST CHESTER, Pa., Dec. 12, 2024 /PRNewswire/ -- Centinel Spine^®, LLC ("the Company"), the leading global medical device company focused exclusively on treating cervical and lumbar spinal disease with the most complete and clinically-proven total disc replacement (TDR) technology platform in the world (prodisc^®), today announced the recent release of a landmark study supporting the long-term clinical success and durability of its prodisc L Lumbar Total Disc Replacement (LTDR) technology.¹ The study has been posted electronically prior to print publication by The Journal of Bone & Joint Surgery, considered the gold-standard in peer-reviewed orthopedic scientific information.

This retrospective study expands the evidence validating the fixed-core design of the prodisc L device and includes 1,187 patients that underwent LTDR surgery for chronic lumbar degenerative disc disease (DDD), making it one of the largest LTDR patient cohorts ever evaluated. The study was also one of the first of its kind to evaluate LTDR patients across such a long duration of follow-up—7 to 21 years (mean of 11 years and 8 months). The goal of the study was to evaluate the clinical outcomes of patients who underwent 1- or 2-level LTDR, as well as to evaluate patients with or without prior discectomy at the index level(s).

The study covered all eligible LTDR procedures performed at a single institution (Montpellier Spine Institute (CCV) Clinique du Parc, Castelnau-le-Lez, France) from 1999 to 2013, and included 772 patients that underwent a 1-level LTDR procedure and 415 that underwent a 2-level procedure. A total of 373 of the patients had prior discectomy surgery.

According to the long-term results of the study, there was statistically equivalent improvement in outcomes for 1-level LTDR and 2-level LTDR, for patients both with and without prior discectomy surgery. This study also demonstrates the robust long-term clinical success and implant survivorship of prodisc L through an extremely low index revision rate of 0.67%. Additionally, a low adjacent-level surgery rate of 1.85% confirmed that the prodisc L design coupled with LTDR mobility restoration supports long-term preservation of adjacent levels.

The lead author of the study is French orthopedic spine surgeon Thierry Marnay, MD, who invented the prodisc lumbar technology as a motion-sparing alternative to fusion. Speaking about the study, Dr. Marnay stated, "Total disc replacement, and especially the prodisc technology, is a concept we started to develop in the 1980s. This study was conducted with the clinical team in Clinique du Parc Montpellier over the last 25 years, and ultimately published in one of the most prestigious scientific journals. The quality and the robustness of its results are a major achievement that fundamentally confirms the long-term efficiency and safety of LTDR through an anterior approach and the positive clinical results for patients after surgery with prodisc L." Dr. Marnay continued, "It is no longer possible to ignore the fundamental positive outcomes through the preservation and/or restoration of spine mobility. There is a direct link between this recovered, pain-free mobility and everyday quality of life."

The prodisc L technology has been proven after almost 35 years of clinical use and over 125,000 devices implanted worldwide.² The prodisc L LTDR system now includes FDA approvals for one-level indications, two-level indications and, most recently, for Anatomic Endplate^™ versions of the implant.

¹ Marnay, Thierry P.; Geneste, Guillaume Y.; Edgard-Rosa, Gregory W.; Grau-Ortiz, Martin M.; Hirsch, Caroline C.; Negre, Georges G. Clinical Outcomes After 1 and 2-Level Lumbar Total Disc Arthroplasty: 1,187 Patients with 7 to 21-Year Follow-up. November 22, 2024. J Bone Joint Surg Am. 2024;00:1-13. http://dx.doi.org/10.2106/JBJS.23.00735
² Data on file for prodisc L.

About Centinel Spine, LLC

Centinel Spine^®, LLC is the leading global medical device company exclusively focused on addressing cervical and lumbar spinal disease with prodisc^®, the most complete total disc replacement (TDR) technology platform in the world.

The Company's prodisc technology is the most studied and clinically-proven TDR system across the globe, validated by over 540 published papers and more than 250,000 implantations. Centinel Spine's prodisc is the only TDR technology with multiple motion-preserving anatomic solutions, allowing the surgeon to Match-the-Disc^™ to each patient's anatomy for both cervical and lumbar total disc replacement.

For more information, please visit the company's website at www.CentinelSpine.com or contact:

Varun Gandhi
Chief Financial Officer
900 Airport Road, Suite 3B
West Chester, PA 19380
Phone: 484-887-8871
Email: [email protected]

SOURCE Centinel Spine, LLC