- Centinel Backbone stays the clear worldwide chief within the lumbar whole disc alternative (LTDR) market1, and its professionaldisc L system is the one LTDR system within the U.S. authorised for one- and two-level use within the lumbar spine.
- The LTDR market stays one of many quickest rising segments in all of orthopedics, exhibiting a compound annual development price (CAGR) of over 25% within the U.S. over the past 5 years.1
- A landmark 20-year consecutive-series retrospective examine with over 2,000 sufferers helps the sturdiness and reliability of LTDR gadgets, demonstrated via a low 1.26% revision price.2
- Sturdy sustained development within the LTDR market is anticipated to proceed as extra long-term information is revealed, the reimbursement panorama strengthens, and affected person demand for the process continues to extend.
WEST CHESTER, Pa., Aug. 22, 2024 /PRNewswire/ — Centinel Backbone®, LLC (“the Firm”), the main world medical system firm targeted solely on treating cervical and lumbar spinal illness with probably the most full and clinically-proven whole disc alternative (TDR) know-how platform on the earth (professionaldisc®), right this moment introduced information supporting sturdy market development and the long-term sturdiness and reliability of the lumbar whole disc alternative (LTDR) process.
Knowledge from a landmark long-term LTDR examine out of the Texas Again Institute (Plano, Texas) helps the sturdiness and reliability of the LTDR process, demonstrated via a low 1.26% elimination/revision price throughout 20 years.2 The examine collected information starting within the 12 months 2000 for a consecutive sequence of two,141 LTDR sufferers, with a imply follow-up of 78.6 months. Of the 258 sufferers with better than or equal to 15-year follow-up, just one affected person underwent elimination/revision. The examine concluded that the low elimination/revision price over a 20-year interval helps the security of LTDR.
In line with Dr. Richard Guyer, orthopedic spine surgeon with the Heart for Disc Alternative, Texas Again Institute, and lead writer of the examine, “The aim of this examine was to analyze the survival charges for lumbar whole disc alternative. Once we started to make the most of this process within the early 2000s, there have been questions concerning long-term efficacy—notably the necessity for future system elimination or revision. The extremely low elimination/revision price on this information throughout 1000’s of sufferers far exceeded our expectations and, we consider, is considerably higher than knee and hip alternative revision charges over the identical time frame. Lumbar whole disc alternative has been an especially efficient process in our follow.”
Centinel Backbone is the quickest rising firm of scale within the spine trade3 and is devoted solely to cervical and lumbar whole disc alternative. The LTDR market is likely one of the quickest rising segments in orthopedics, exhibiting a compound annual development price (CAGR) of greater than 25% within the U.S. over the past 5 years.1 Additional, the Firm has outperformed the general LTDR market development for over 5 years and expects sturdy sustained future LTDR development on account of:
- Continued publication of long-term LTDR information: An increasing number of information with constructive long-term implant survivorship—such because the 20-year LTDR examine out of the Texas Again Institute—is anticipated to be revealed, now that nearly 20 years have handed for the reason that professionaldisc L U.S. IDE trial was accomplished. Equally constructive information from a world long-term professionaldisc L examine of as much as 21 years, throughout a big affected person cohort, has been reported.4 The professionaldisc know-how is probably the most studied whole disc alternative system and has been validated throughout 540 revealed papers throughout its nearly 35 years of scientific utilization.
- Strengthening reimbursement protection: With a number of latest favorable payor protection choices, it’s estimated that industrial protection within the U.S. for one-level LTDR has grown to almost 95% right this moment.5 An analogous development in direction of common protection for two-level LTDR is anticipated as extra industrial payers think about the constructive long-term scientific information that continues to be revealed.
- Growing affected person demand: As public consciousness of the potential advantages of LTDR builds and sufferers naturally search motion-preserving surgical options, demand for the LTDR process is anticipated to be pushed on the affected person degree. Based mostly on inside affected person search information from the Firm, sufferers searching for LTDR surgical care has elevated by over 70% in 2024 versus 2023.6 Dr. Richard Guyer provides, “Sufferers present process the lumbar whole disc alternative process are amongst our most grateful and happiest sufferers.”
Centinel Backbone CEO Steve Murray concludes, “We see ongoing development within the lumbar whole disc alternative marketplace for years to come back, with professionaldisc L main the best way. More and more, sufferers are sharing the life-changing influence this process has on their welfare and high quality of life. Moreover, the scientific proof and long-term success of the lumbar whole disc alternative process and know-how speaks for itself versus spinal fusion and plenty of different joint alternative surgical procedures.”
The primary-generation of the professionaldisc know-how was invented as a motion-sparing various to interbody fusion and, in 1990, the primary professionaldisc L LTDR system was implanted. After nearly 35 years and over 120,000 professionaldisc L LTDR gadgets implanted worldwide, the professionaldisc know-how has been validated with a reported reoperation price of lower than 1%.7 The professionaldisc L LTDR know-how portfolio now contains FDA approvals for one-level indications, two-level indications and, most lately, for the Anatomic Endplate™ model of professionaldisc L.
1 This fall’23 ADR MedSKU Replace, iData Analysis and Knowledge on File.
2 Richard D. Guyer MD, Scott L. Blumenthal MD, Jessica L. Shellock MD, Jack E. Zigler MD, and Donna D. Ohnmeiss PhD. Lumbar Whole Disk Alternative System Removals and Revisions Carried out Throughout a 20-Yr Expertise with 2141 Sufferers. Backbone. 2024;49(10):671-676. Observe: Centinel Backbone’s professionaldisc L system is authorised within the U.S. for one- and two-level use within the lumbar spine and isn’t indicated for all procedures overviewed within the examine.
3 Based mostly on publicly accessible info.
4 Marnay, Thierry. “7 to 21 12 months scientific outcomes of 1,187 sufferers handled with one and two degree lumbar whole disc arthroplasty”, ISASS 2021 Annual Assembly, Might 14, 2021, Miami, FL.
5 Knowledge on File, estimate primarily based on mixed constructive and impartial insurance policies.
6 Knowledge on File, primarily based on Centinel Backbone Surgeon Locator search information in 1H-2024 vs 1H-2023.
7 Based mostly upon U.S. grievance dealing with models for professionaldisc since launch in 2006.
About Centinel Backbone, LLC
Centinel Backbone®, LLC is the main world medical system firm solely targeted on addressing cervical and lumbar spinal illness with professionaldisc®, probably the most full whole disc alternative (TDR) know-how platform on the earth.
The Firm’s professionaldisc know-how is probably the most studied and clinically-proven TDR system throughout the globe, validated by over 540 revealed papers and greater than 250,000 implantations. Centinel Backbone’s professionaldisc is the one TDR know-how with a number of motion-preserving anatomic options, permitting the surgeon to Match-the-Disc™ to every affected person’s anatomy for each cervical and lumbar whole disc alternative.
For extra info, please go to the corporate’s web site at www.CentinelSpine.com or contact:
Varun Gandhi
Chief Monetary Officer
900 Airport Street, Suite 3B
West Chester, PA 19380
Telephone: 484-887-8871
Electronic mail: v.gandhi@centinelspine.com
SOURCE Centinel Backbone, LLC
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