X-Stop Spacer

How It Works

Lumbar spinal stenosis, or LSS, is one manifestation of the natural process of spinal degeneration that occurs with aging, and often becomes symptomatic in the fifth and sixth decades of life. With increases in life expectancy and the aging of the baby boom generation, more people are living to an age where this condition becomes symptomatic, presenting as neurogenic intermittent claudication, and requiring surgical intervention. LSS is a narrowing of the spinal canal or neural foramina resulting from the gradual degeneration of the intervertebral disc; a loss of disc height, causing the affected spinal segment to adopt a position of hyper-extension, leading to a bulging of the annulus, hypertrophy of the facets, spondylolisthesis; and a thickening of the interspinous ligaments, in particular the ligamentum flavum. The narrowing of the spinal canal and neural foramina produce root ischemia and neurogenic claudication.

The posture of patients with LSS while walking is, typically, kyphotic. Extension of the spine often provokes symptoms while flexion relieves them.

Typically, x-rays are taken to assess the alignment of the spine and the extent of any degenerative bony changes. CT scans are effective in showing the shape and dimensions of the canal and its bony components. MRI scanning is helpful in defining nerve root impingement, disc bulging, ligamentum flavum hypertrophy, disc degeneration and other soft tissue conditions.

Radiological evidence of stenosis must be correlated with the patient’s symptoms before the diagnosis can be confirmed.

Once a positive diagnosis has been made, the process of treating LSS begins with a regimen of nonsurgical medical management. While some patients respond to this treatment, many do not and become candidates for surgical intervention. The most common surgical procedure for LSS is decompressive laminectomy, which entails the removal of the lamina and other anatomical elements to relieve pressure on the neural structures. When spinal instability may result from a laminectomy procedure, a fusion is also performed.

X-Stop Interspinous Spacer System – An Alternative to Decompression for Neurogenic Intermittent Claudication (NIC)

Interspinous Process Decompression is a minimally invasive surgical procedure in which an implant is placed between the spinous processes of the symptomatic disc levels. The X-Stop Interspinous Spacer System was developed for patients who have LSS, suffer symptoms of neurogenic intermittent claudication, and who are able to relieve their symptoms when they bend forward or flex their spines. The X-Stop Spacer is an implant that is designed to limit pathologic extension of the spinal segments and maintain them in a neutral or slightly flexed position, which may allow patients to resume their normal posture rather than flex the entire spine to gain symptom relief.

The unique design of the X-Stop Spacer allows it to be implanted with a straight-forward approach without fixation to bones or ligaments.

The potential advantages of treatment using the X-Stop Interspinous Spacer procedure over decompressive laminectomy are:

• The procedure usually can be performed using a local anesthetic, so patients with comorbidities that prohibit the use of general anesthesia can be treated.
• The procedure usually can be performed on an outpatient basis.
• There is usually no tissue or bone resection.
• The spinal canal is not compromised.
• OR time is usually under 60 minutes.
• Morbidity or complications occurred at a low rate in the clinical trial.
• Most patients experience rapid relief of LSS symptoms and improvement of physical function.