Centinel Spine recently announced, via a press release, data supporting strong market growth and the long-term durability and reliability of the lumbar total disc replacement (LTDR) procedure.
Data from a landmark long-term LTDR study out of the Texas Back Institute supports the durability and reliability of the LTDR procedure, demonstrated through a low 1.26% removal/revision rate across 20 years.1 The study collected data beginning in the year 2000 for a consecutive series of 2,141 LTDR patients, with a mean follow-up of 78.6 months. Of the 258 patients with greater than or equal to 15-year follow-up, only one patient underwent removal/revision. The study concluded that the low removal/revision rate over a 20-year period supports the safety of LTDR.
"The purpose of this study was to investigate the survival rates for lumbar total disc replacement. When we began to utilize this procedure in the early 2000s, there were questions regarding long-term efficacy—particularly the need for future device removal or revision. The incredibly low removal/revision rate in this data across thousands of patients far exceeded our expectations and, we believe, is significantly better than knee and hip replacement revision rates over the same period of time. Lumbar total disc replacement has been an extremely effective procedure in our practice. Patients undergoing the lumbar total disc replacement procedure are among our most grateful and happiest patients."
-Dr. Richard Guyer, Orthopedic Spine Surgeon with the Center for Disc Replacement, Texas Back Institute, and Lead Author of the Study
The LTDR market is one of the fastest growing segments in orthopedics, exhibiting a compound annual growth rate (CAGR) of more than 25% in the U.S. over the last five years.2 Further, the Company has outperformed the overall LTDR market growth for over five years and expects strong sustained future LTDR growth due to continued publication of long-term LTDR data, strengthening reimbursement coverage, and increasing patient demand.
References:
- Richard D. Guyer MD, Scott L. Blumenthal MD, Jessica L. Shellock MD, Jack E. Zigler MD, and Donna D. Ohnmeiss PhD. Lumbar Total Disk Replacement Device Removals and Revisions Performed During a 20-Year Experience with 2141 Patients. Spine. 2024;49(10):671-676. Note: Centinel Spine’s prodisc L device is approved in the U.S. for one- and two-level use in the lumbar spine and is not indicated for all procedures overviewed in the study.
- Q4'23 ADR MedSKU Update, iData Research and Data on File.