According to GlobalData the global spinal nonfusion market valued $696m in 2016 and is expected to grow to $1.3bn in 2023 propelled by the adoption of cervical ADR systems.These nonfusion devices include the pedicle screw-based dynamic stabilisation systems among others (ADR systems, interspinous process decompression (IPD) devices). Only cervical artificial disc replacement systems have collected a body of evidence ample enough to support their use beyond investigational status in the US and as a viable treatment option in Europe. These devices are expected to drive growth in the spinal nonfusion market over the next five years.
1.- The pedicle screw-based dynamic stabilisation systems: How big is the market?
GlobalData considered that the Pedicle screw-based dynamic stabilization market accounted for 27,10% of the global nonfusion market (188 million) and will grow to 323 million in 2023.Although Spinal fusion is currently considered the gold standard in degenerative spine treatment, accomplishing both deformity correction and stabilization, the posterior pedicle screw-based dynamic stabilization systems are still an alternative to the rigid stabilization of spinal fusion for patients with back pain due to spinal instability. They evoked interest in their infancy, but their promise has tapered in the wake of insufficient clinical efficacy.
2.- Which are the most relevant Pedicle screw-based dynamic stabilisation systems?
We have included in our list, the 45 most relevant systems taking into account that many of them are no longer in the market. To know the 45 most relevant Pedicle Screw Dynamic Stabilization Devices please visit: https://thespinemarketgroup.com/category/dynamic/
3.- Which Devices have been approved by the FDA?
No dynamic stabilization devices have received approval from the U.S. Food and Drug Administration (FDA) for use other than as an adjunct to spinal fusion. The FDA has specified that separate approval is required for “off-label” marketing of these devices, including but not limited to use as a stand-alone device for spinal stabilization in the absence of fusion.
4.- How are the Dynamic Posterior systems used outside US?
Outside the United States, they are used in treating multi-level spinal surgeries requiring fusion at one or more levels and neutral stabilization (non fusion) at an adjacent level for common spine conditions such as spinal stenosis and early stage degenerative disc disease.
5.- What is Posterior Dynamic Stabilization?
Dynamic stabilization is a surgical technique designed to allow for some movement of the spine, while maintaining enough stability to prevent too much movement.If your spine is unstable, excessive motion can cause the nerves adjacent to the spinal column to become pinched. This can lead to leg pain, numbness, and weakness. By stabilizing the spinal column, the idea is to limit abnormal motion of the spinal segments, and prevent nerve impingement.
6.-Dynamic Stabilization vs. Lumbar Fusion?
Traditionally, stabilization of the lumbar spine was accomplished with fusion. Fusion surgery of the spine is accomplished by stimulating bone to grow between two or more adjacent spinal segments to prevent future motion. Often metal instrumentation is used to stabilize the spinal segments while bone eventually forms between the vertebrae.Dynamic stabilization is an alternative to fusion. The instrumentation used in dynamic stabilization is designed to control the amount of motion between adjacent vertebrae, but it does not completely eliminate this movement.
7.- Why Dynamic Stabilization?
One of the major problems with spinal fusion is that even when all goes well and the spinal segments fuse, problems can arise down the road. Once two spinal segments have fused, extra stresses are transferred to the discs above and below the fusion. These segments tend to wear out more quickly, which can necessitate additional surgical procedures down the road. This is especially problematic in younger, more active patients.
8.- Which are the Indications for Posterior Dynamic Systems?
Although the indications for PDS are still being identified, there are several disorders in which the devices are expected to play a role. These are detailed in the sections that follow.
Controlled Motion in the Iatrogenically Destabilized Spine
Spinal surgery for neural entrapment syndromes typically involves a partial or complete laminectomy with some element of facet joint removal. Although minimal access procedures such as microdiscectomy require very little bone removal, the treatment of lumbar spinal stenosis accompanied by lateral recess stenosis and superior facet encroachment can result in significant facet joint resection. In some instances this results in iatrogenic destabilization,1 requiring the surgeon to decide whether to fuse the patient’s spine primarily or watch expectantly for the finite possibility of sagittal plane imbalance or deformity. One possible role of PDS devices would be to limit and control motion after a potentially destabilizing laminectomy, avoiding the need for arthrodesis and reducing the likelihood of iatrogenic destabilization.
Increased Anterior Load Sharing to Augment Interbody Fusion
Although pedicle screw/rod stabilization is typically used as an adjunct in these operations, concerns have arisen surrounding the highly rigid nature of these constructs. Stress shielding of the interbody graft is believed to be implicated in a certain percentage of pseudarthroses.Thus, PDS devices may play a role in limiting the extremes of motion, which could result in graft displacement, while allowing for maximal anterior load sharing and fusion.
Protection and Restoration of Degenerated Facet Joints and Intervertebral Discs
This is perhaps the most controversial and least understood indication for PDS. Contemporary surgical treatments for spinal pain generators, such as the intervertebral disc or facet joints, involve extirpation or complete destruction of the poorly functioning unit. In the case of what is believed to be discogenic pain, the disc is completely removed and replaced with an interbody fusion or arthroplasty device. Alternatively, a posterior fusion can be used to treat facet or disc disease, with the goal of preventing any motion in the diseased unit. The PDS devices may be able to shield the disc and facet joint structures from motion that is destructive, potentially allowing for a reduction in local inflammatory processes or permitting self-repair mechanisms.
In Combination With Anterior Motion Preservation for 360˚Circumferential Motion Segment Reconstruction
One of the major drawbacks of total disc arthroplasty is that facet disease remains a contraindication. In fact, it is believed that disc arthroplasty may accelerate facet degeneration.Using PDS technology, circumferential reconstruction of all the mobile units in a spinal segment (the intervertebral disc and two facet joints) becomes possible.
Adaptation of Stabilization Techniques to the Aging Spine
Current spinal stabilization devices (pedicle screws and rods or transfacet screws) provide a high degree of rigidity. Although this can be desirable, the use of these devices in the treatment of patients with osteopenia or osteoporosis can result in catastrophic destruction of host bone at metallic interfaces.The application of “softer stabilization” techniques may be more desirable in these settings, reducing the likelihood of construct failure.
Prevention of Fusion-Related Sequelae
Perhaps the most widely appreciated application of PDS lies in its theoretical advantages over rigid arthrodesis. Loss of spinal motion due to fusion can result in a number of sequelae, including accelerated adjacent-level degeneration, fusion into states of malalignment, and pseudarthrosis. With respect to adjacent-level disease, it is believed that the elimination of mobility can overload adjacent segments and lead to accelerated degeneration and arthrosis. This can result in axial pain, deformity and kyphosis, and neurological compression.Furthermore, loss of lumbar lordosis as a result of poorly contoured or excessive distraction of instrumentation can lead to flatback deformity or fixed sagittal imbalance. This syndrome can result in postoperative pain, hardware failure, fatigue, and gait disturbance characterized by an inability to stand erect without flexing the knees and extending the hips to compensate for loss of segmental lumbar lordosis.Finally, pseudarthrosis is a significant complication of fusion surgery, with a reported incidence that can reach 30% in certain circumstances.Frequently, it requires repeated operation, adding to patient morbidity and costs.
SOURCE:http://thejns.org/Classification of posterior dynamic stabilization devices
TONY BROWN says
Let’s talk about Access, all these systems wither there advantages are putting the cart before scalpel. Open, Freehand Minimally Invasive Surgery Access and computer/robotic assisted techniques are the standard excepted procedure for inpimentation. The latter seeks to level the field for the second and both of these seek to replace the first. There is no question MIS should bye used in most cases but it has turned into a million dollar solution for a hundred thousand dollar problem. For the most part this problem has frustrated surgeons much like the early pain management physicians of 20 years ago. Being a witness to the process that changed what use to be a 45 minute procedure into a 5 minute one, I can confidently say I have some Insite in the matter. Using a radiographic approach in dealing with proper skin entry placement and trajectories spicefic fir each site, will decrease the number of attempts and therefore reduce the procedure time but most importantly radiation exposure. Wish to know more contact us at info@marksmantargeting