When we talk about Interspinous Devices, we refer to two categories of implants: Interspinous Distraction Devices and Interspinous fixation (fusion) devices.
Interspinous Distraction Devices
The Interspinous implants are intended to restrict painful motion while otherwise enabling normal motion. The devices, also known as spacers, distract the spinous processes and restrict extension. Theoretically, this enlarges the neural foramen in patients with spinal stenosis and neurogenic claudication.
In Europe, this IPD market, is still growing at a significant rate setting to rise to around $30.3 million in 2023 (annual growth rate of 6.3 percent) , according to research and consulting firm GlobalData. The key drivers of this relatively strong growth include the growing prevalence of degenerative spinal conditions due to aging populations and IPD’s advantages over traditional spinal fusion and laminectomy procedures, including motion preservation and a minimally invasive procedure with no bone removal.Also, the market for IPD devices is growing as a result of the procedure’s minimally invasive nature, its potential to be performed in the outpatient setting, and the motion-preserving technology incorporated in each implant,” explained GlobalData.
In US, the market for Interspinous Distraction Devices started in November 2005, when the X-STOP® Interspinous Process Decompression System was approved by the Food and Drug Administration (FDA) but was the unique device approved until in 2012 the coflex® Interlaminar (Paradigm Spine) finally achieved the FDA.
Which is the future of the Interspinous Devices? Are they useful?
According to the North American Spine Society (NASS), current evidence is insufficient to permit conclusions about whether any beneficial effect from interspinous process distraction or interlaminar stabilization spacers provides a significant advantage over surgical decompression, which is the current standard of care for surgical treatment of lumbar spinal stenosis.
But many European Studies, show that there is no convincing evidence that these devices provide any patient benefits but biomechanical studies have shown that IPDs significantly reduce intradiscal pressure, as well as the facet load, and prevent narrowing of the spinal canal and neural foramina.Additionally, for some patients with LSS, IPDs may be a viable alternative to the gold standard (Source:http://www.openaccessjournals.com/articles/efficacy-of-an-interspinous-decompression-device-versus-nonoperative-treatment-for-lumbar-spinal-stenosis-an-example-for.pdf).
Interspinous fixation (fusion) devices
Recently, the interest in interspinous devices has emerged again with a great focus on nonfusion.They are intended to be an alternative to pedicle screw and rod constructs and also to aid in the stabilization of the spine with interbody fusion. ISP fixation are increasingly gaining acceptance among treating physicians due to decreased surgical and hospitalization time, reduced complications rates and estimated blood loss, as well as the complimentary effect of decreased overall costs for the procedure.
Interspinous fixation (fusion) devices contrast with interspinous distraction devices (spacers), which are used alone for decompression and are typically not fixed to the spinous process. In addition, whereas interspinous distraction devices may use dynamic stabilization, interspinous fixation devices are rigid. However, the fixation devices might also be used to distract the spinous processes and decrease lordosis. Thus, the fixation devices might be used off-label without interbody fusion as decompression (distraction) devices in patients with spinal stenosis. If fixation devices are used alone as a spacer, there is a risk of spinous process fracture.
Which is the future of the Interspinous Devices? Are they useful?
For use in combination with fusion, it is proposed that interspinous fixation systems are less invasive and present fewer risks than pedicle or facet screws. However, while biomechanical studies indicate that interspinous fixation devices may be similar to pedicle screw-rod constructs in limiting the range of flexion-extension, they may be less effective than bilateral pedicle screw-rod fixation for limiting axial rotation and lateral bending. There is a potential for a negative impact on the interbody cage and bone graft due to focal kyphosis resulting from the interspinous device. There is also a potential for spinous process fracture. Given these uncertainties, studies are needed that compare health outcomes between interspinous fixation devices and pedicle screw-rod fixation.
Which are the 65 devices in the market?
In terms of key players, the IPD devices market is fairly consolidated, composed of a mix of orthopedic and spine conglomerates as well as small players with a sole focus on spinal non-fusion devices. Please find the 65 most important devices in:https://thespinemarketgroup.com/category/interspinous/
Sameer Kitab says
Patients frequently complained of back pain that negates the theory of reduced intradiscal or facet pressures . Interspinous spacers effects on the quality of lumbar movement and coupled motions are not physiological. Radicular pain may have improved.
Fabio says
Pecutaneous interspinous devices have been withdrawn from the market. Are they unuseless? Any reason?