Spinal-Stabilization - Model PerQdisc - Nucleus Replacement System
The SST PerQdisc Nucleus Replacement System is intended to replace the nucleus pulposus of the intervertebral disc in the L1-S1 spinal region in patients with single-level discogenic pain. The patient may have single or multi-level degenerative disc changes but the discogenic pain must be limited to a single level. The patient must be skeletally mature, at least 21 years of age, presenting with moderate to severe low back pain (with or without leg pain) that is unresponsive to non-surgical conservative treatments. The patient should not have a history of prior lumbar spine surgery. The patient should have a minimum disc height of 6 mm.
Products Details
Spinal Stabilization Technologies™ introduces a potentially less invasive surgical treatment when compared to spinal fusion or total disc replacement: The PerQdisc™ Nucleus Replacement System. A technique where only a small portion of the outer disc needs to be exposed, the PerQdisc system replaces the diseased and dysfunctional nucleus pulposus in an effort to recreate physiological motion and redistribute the weight bearing forces and mechanical properties of the disc in a more natural fashion.
Spinal Stabilization Technologies™ introduces a potentially less invasive surgical treatment when compared to spinal fusion or total disc replacement: The PerQdisc™ Nucleus Replacement System. A technique where only a small portion of the outer disc needs to be exposed, the PerQdisc system replaces the diseased and dysfunctional nucleus pulposus in an effort to recreate physiological motion and redistribute the weight bearing forces and mechanical properties of the disc in a more natural fashion.
PerQdisc Mechanism of Action
The PerQdisc (Figure 2) acts by replacing the physical space of the nucleus with an implant that aims to behave in a similar fashion to a healthy native nucleus. The PerQdisc™ is comprised of an incompressible material which, when contained by the annulus provides 50% of the load bearing requirements of the motion segment.
Treatment Options
Historically, conservative treatment options for Discogenic Low Back Pain (dLBP) have included physical therapy, pharmaceutical pain management, and various intradiscal injections. While conservative therapies have shown efficacy, some patients may be unresponsive, and a surgeon might consider more invasive surgical options after failed conservative treatment.
Spinal Fusion and Total Disc Replacement have been surgical treatment options for latter stages of symptomatic Disc Degeneration. Spinal Stabilization Technologies™ introduces a potentially less invasive alternative surgical treatment: The PerQdisc™ Nucleus Replacement System.
PerQdisc Nucleus Replacement
Nucleus replacement is a surgical procedure that limits tissue disruption to the intervertebral disc. Unlike fusion techniques, and TDR procedures that require aggressive resection of all or a portion of the disc, the PerQdisc surgical procedure aims to preserve the annulus fibrosus (AF) and cartilaginous endplates.
The PerQdisc Nucleus Replacement offers an anatomical and biomechanical, motion-preserving, surgical alternative to fusion and total disc replacement. The PerQdisc replaces the physical space of the nucleus, in an effort to recreate physiological motion, and redistribute the weight bearing forces and mechanical properties of the disc in a more natural fashion.
The PerQdisc is thought to treat dLBP by removing the damaged nucleus tissue while the nucleus replacement implant supports the annulus fibers and nearby tissue. The PerQdisc surgical technique requires a small dilation into the AF, which facilitates access and resection of the nucleus pulposus, allowing for a focused area of attention with minimal damage to surrounding tissue.
The PerQdisc’s innovative technology provides a patient-specific, form-fitting, custom implant, unique to each individual patient. (See figure 1.)
Spinal Fusion
Spinal Fusion is a surgical procedure where two or more of the vertebrae of the spine are joined together using different combinations of implants and hardware. There are several varied surgical techniques, and devices that may be used to perform a spinal fusion. The procedure is designed to restrict movement in the involved segment in order to relieve pain by preventing abnormal motion in the degenerated disc that leads to inflammation and irritation. This lack of mobility has caused concern about degeneration at adjacent levels that need to make up the difference in the loss of flexibility in the spine.
Total Disc Replacement
A Total Disc Replacement (TDR) is an alternative to fusion surgery. A TDR surgery involves removing the intervertebral disc and replacing it with an articulating device that is intended to allow for movement in the affected segment. The goal of motion preserving devices is to remove the affected disc while decreasing the incident of adjacent segment degeneration. Although a TDR is designed to preserve motion, total resection of the disc is required, the resulting movements are not fully physiological, and there are limited sizing options available.
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