Nathaniel Bool and Kamran Zamanian, iData Research05.20.24
The landscape o
f spinal care in the United States is continuously evolving, with various trends shaping the trajectory of the US spine implant and vertebral compression fracture (VCF) market. Among these trends, vertebral body tethering emerges as a revolutionary approach to addressing idiopathic scoliosis, a challenging spinal curvature that often manifests during adolescence. Unlike traditional spinal fusion methods, which restrict spinal mobility, vertebral body tethering preserves movement through a flexible cord, offering dynamic correction while accommodating the evolving needs of a growing spine. This article explores the nuances of vertebral body tethering, including its unique attributes, market dynamics and promising future within the realm of spinal interventions.
The procedure involves strategically placing screws into the affected vertebrae and securing them with a flexible cord. This cord, often made of a durable material, acts as a guide for the spine's growth, gently nudging it into the correct alignment over time. What sets vertebral body tethering apart is its adaptability – rather than locking the spine in place, it allows for gradual correction, accommodating the natural progression of a patient's growth.
There are only two VBT devices approved for use by the FDA. Zimmer Biomet's spine unit, which was spun out to form ZimVie and is now HighRidge Medical, received FDA approval for The Tether in 2019. This product represented the only competitor in the market until Globus Medical received FDA approval for its REFLECT scoliosis correction system in 2023.
One of the key drivers of the VBT market lies in its motion preservation capabilities. Traditional spinal fusion procedures, while effective in straightening the spine, can limit the range of motion and flexibility. Vertebral body tethering, however, aims to strike a balance by rectifying the curvature without compromising the natural movement of the spine. This approach is particularly beneficial for adolescents who are still growing and active, as it allows them to maintain a more natural range of motion.
While vertebral body tethering presents a promising non-fusion option in the treatment of idiopathic scoliosis, the market currently grapples with limitations attributed to its status as a relatively new procedure. As with any innovative medical intervention, the initial stages are often characterized by a restricted adoption rate and a cautious approach from both healthcare professionals and patients.
One significant limitation is the learning curve associated with performing vertebral body tethering procedures. This procedure is dynamic and may require adjustments outside the standard course. Some cases may utilize extra cords, tension on both sides on the spine or even partial fusion in some cases. Additionally, the limited clinical data available, as compared to more established procedures like spinal fusion, may contribute to hesitancy among medical professionals and patients alike. Another factor to consider is the fact that the procedure is quite expensive relative to spinal fusion. A study shows that the total discounted costs for a VBT procedure were nearly $97,000, whereas the total costs for a spinal fusion were estimated to be just over $51,000 (Polly et al. 2021).
However, despite these current limitations, the trajectory of vertebral body tethering in the market is one of growth and evolution. As the procedure and its benefits gain more acceptance, it is likely that the market will expand. Ongoing research, improvements in surgical techniques and a growing body of evidence supporting the effectiveness of vertebral body tethering will contribute to overcoming these initial limitations. The future holds the promise of a more robust market for this innovative non-fusion option, providing a valuable alternative in the landscape of spinal interventions.
Chart 1: Vertebral Body Tethering Market Value by Segment, U.S., 2020-2030
![](https://images.rodpub.com/images/306/945_main.jpg)
What sets this procedure apart is not only its clinical success but also its integration into various healthcare settings. The notable traction within ambulatory surgical centers is indicative of its increasing prevalence and acceptance among both healthcare providers and patients. This shift toward ambulatory surgical centers not only streamlines the procedure but also underscores its suitability for outpatient settings, reflecting a significant volume of cases and a more patient-centric approach to spinal interventions.
Simultaneously, the lumbar artificial disc market is experiencing rapid expansion, with Centinel Spine and Aesculap emerging as key players dominating the U.S. market. Overcoming historical obstacles where the technology was viewed as experimental and investigational, lumbar artificial discs have successfully transitioned into a mainstream option for spinal care.
A crucial driver in this evolution is the substantial increase in insurance coverage for single-level lumbar total disc replacement, now reaching an impressive 95% of insurers. Two-level coverage is also starting to be accepted by select insurance providers, further showing the acceptance of lumbar total disc replacement within the U.S. market. This remarkable shift in perception and the concurrent increase in coverage not only signify a growing confidence in lumbar artificial discs but also position them as a well-established and widely accepted intervention in the realm of spinal care.
The cervical disc replacement portion of this market narrative encapsulates not only the clinical effectiveness of cervical disc replacement but also its seamless integration into diverse healthcare settings, showcasing a transformative journey toward becoming a standard procedure. The convergence of clinical data, expanded insurance coverage and heightened patient awareness collectively propel the artificial disc market forward, setting the stage for continued growth and advancements in the field of spinal care.
Chart 2: Artificial Disc Market Value by Segment, U.S., 2020-2030
![](https://images.rodpub.com/images/306/947_main.jpg)
Vertebral body tethering offers a dynamic solution for idiopathic scoliosis, marking a significant shift in spinal treatment methods. Despite initial challenges, its trajectory is one of growth and evolution, positioning it as a transformative approach in spinal care.
Simultaneously, the artificial disc market, focusing on both cervical and lumbar regions, showcases progress in motion preservation and adaptability. Cervical disc replacement, gaining popularity across various healthcare settings, demonstrates its effectiveness and potential for widespread use. Similarly, the lumbar artificial disc market has overcome past obstacles and now sees dominance from key manufacturers, along with increased insurance coverage. These advancements highlight the growing acceptance and effectiveness of artificial disc procedures, providing a nuanced and patient-centered approach to spinal health.
Nathaniel Bool is a research analyst at iData Research. He develops and composes syndicated research projects regarding the medical device industry, publishing the U.S. Spinal Implant, and the Minimally Invasive Spinal Implant report series.
Kamran Zamanian, Ph.D., is CEO and founding partner of iData Research. He has spent over 20 years working in the market research industry with a dedication to the study of medical devices used in the health of patients all over the globe.
Vertebral Body Tethering
Vertebral body tethering is a cutting-edge surgical procedure designed to address idiopathic scoliosis, a curvature of the spine that typically emerges during adolescence. Unlike traditional spinal fusion, which limits the movement of the spine, tethering preserves spinal mobility by using a flexible cord to guide the growth of the spine as the patient continues to develop. This dynamic approach not only corrects the curvature but also allows for ongoing adjustments, catering to the changing needs of a growing spine.The procedure involves strategically placing screws into the affected vertebrae and securing them with a flexible cord. This cord, often made of a durable material, acts as a guide for the spine's growth, gently nudging it into the correct alignment over time. What sets vertebral body tethering apart is its adaptability – rather than locking the spine in place, it allows for gradual correction, accommodating the natural progression of a patient's growth.
There are only two VBT devices approved for use by the FDA. Zimmer Biomet's spine unit, which was spun out to form ZimVie and is now HighRidge Medical, received FDA approval for The Tether in 2019. This product represented the only competitor in the market until Globus Medical received FDA approval for its REFLECT scoliosis correction system in 2023.
One of the key drivers of the VBT market lies in its motion preservation capabilities. Traditional spinal fusion procedures, while effective in straightening the spine, can limit the range of motion and flexibility. Vertebral body tethering, however, aims to strike a balance by rectifying the curvature without compromising the natural movement of the spine. This approach is particularly beneficial for adolescents who are still growing and active, as it allows them to maintain a more natural range of motion.
While vertebral body tethering presents a promising non-fusion option in the treatment of idiopathic scoliosis, the market currently grapples with limitations attributed to its status as a relatively new procedure. As with any innovative medical intervention, the initial stages are often characterized by a restricted adoption rate and a cautious approach from both healthcare professionals and patients.
One significant limitation is the learning curve associated with performing vertebral body tethering procedures. This procedure is dynamic and may require adjustments outside the standard course. Some cases may utilize extra cords, tension on both sides on the spine or even partial fusion in some cases. Additionally, the limited clinical data available, as compared to more established procedures like spinal fusion, may contribute to hesitancy among medical professionals and patients alike. Another factor to consider is the fact that the procedure is quite expensive relative to spinal fusion. A study shows that the total discounted costs for a VBT procedure were nearly $97,000, whereas the total costs for a spinal fusion were estimated to be just over $51,000 (Polly et al. 2021).
However, despite these current limitations, the trajectory of vertebral body tethering in the market is one of growth and evolution. As the procedure and its benefits gain more acceptance, it is likely that the market will expand. Ongoing research, improvements in surgical techniques and a growing body of evidence supporting the effectiveness of vertebral body tethering will contribute to overcoming these initial limitations. The future holds the promise of a more robust market for this innovative non-fusion option, providing a valuable alternative in the landscape of spinal interventions.
Chart 1: Vertebral Body Tethering Market Value by Segment, U.S., 2020-2030
![](https://images.rodpub.com/images/306/945_main.jpg)
Disc Replacement Growth
Motion preservation within spinal care is undergoing a notable transformation, and artificial discs have emerged as a pivotal segment in this evolutionary trajectory. The surge in popularity of cervical disc replacement is a striking testament to the growing acceptance and efficacy of this innovative intervention. A wealth of literature has substantiated its effectiveness, positioning cervical disc replacement on the trajectory to becoming a standard procedure in spinal care.What sets this procedure apart is not only its clinical success but also its integration into various healthcare settings. The notable traction within ambulatory surgical centers is indicative of its increasing prevalence and acceptance among both healthcare providers and patients. This shift toward ambulatory surgical centers not only streamlines the procedure but also underscores its suitability for outpatient settings, reflecting a significant volume of cases and a more patient-centric approach to spinal interventions.
Simultaneously, the lumbar artificial disc market is experiencing rapid expansion, with Centinel Spine and Aesculap emerging as key players dominating the U.S. market. Overcoming historical obstacles where the technology was viewed as experimental and investigational, lumbar artificial discs have successfully transitioned into a mainstream option for spinal care.
A crucial driver in this evolution is the substantial increase in insurance coverage for single-level lumbar total disc replacement, now reaching an impressive 95% of insurers. Two-level coverage is also starting to be accepted by select insurance providers, further showing the acceptance of lumbar total disc replacement within the U.S. market. This remarkable shift in perception and the concurrent increase in coverage not only signify a growing confidence in lumbar artificial discs but also position them as a well-established and widely accepted intervention in the realm of spinal care.
The cervical disc replacement portion of this market narrative encapsulates not only the clinical effectiveness of cervical disc replacement but also its seamless integration into diverse healthcare settings, showcasing a transformative journey toward becoming a standard procedure. The convergence of clinical data, expanded insurance coverage and heightened patient awareness collectively propel the artificial disc market forward, setting the stage for continued growth and advancements in the field of spinal care.
Chart 2: Artificial Disc Market Value by Segment, U.S., 2020-2030
![](https://images.rodpub.com/images/306/947_main.jpg)
Conclusion
In summary, advancements in spinal care present exciting opportunities for innovation, particularly through techniques like vertebral body tethering and disc replacement.Vertebral body tethering offers a dynamic solution for idiopathic scoliosis, marking a significant shift in spinal treatment methods. Despite initial challenges, its trajectory is one of growth and evolution, positioning it as a transformative approach in spinal care.
Simultaneously, the artificial disc market, focusing on both cervical and lumbar regions, showcases progress in motion preservation and adaptability. Cervical disc replacement, gaining popularity across various healthcare settings, demonstrates its effectiveness and potential for widespread use. Similarly, the lumbar artificial disc market has overcome past obstacles and now sees dominance from key manufacturers, along with increased insurance coverage. These advancements highlight the growing acceptance and effectiveness of artificial disc procedures, providing a nuanced and patient-centered approach to spinal health.
Sources:
Polly DW, Larson AN, Samdani AF, Rawlinson W, Brechka H, Porteous A, Marsh W, Ditto R. Cost-Utility Analysis of Anterior Vertebral Body Tethering versus Spinal Fusion in Idiopathic Scoliosis from a US Integrated Healthcare Delivery System Perspective. Clinicoecon Outcomes Res. 2021 Mar 15;13:175-190. doi: 10.2147/CEOR.S289459. PMID: 33758521; PMCID: PMC7979350.Nathaniel Bool is a research analyst at iData Research. He develops and composes syndicated research projects regarding the medical device industry, publishing the U.S. Spinal Implant, and the Minimally Invasive Spinal Implant report series.
Kamran Zamanian, Ph.D., is CEO and founding partner of iData Research. He has spent over 20 years working in the market research industry with a dedication to the study of medical devices used in the health of patients all over the globe.