X-Stop Disc Decompression

The X-Stop device is a significant breakthrough. It is a minimally invasive device that allows one to treat focal spinal cord compression without hospitalization and without general anesthesia. The procedure IPD procedure (intraspinous process decompression) takes about 30 minutes and works 75 to 90 percent of the time. By separating the posterior parts of the vertebral bone (the spinous processes), the device gives the spinal cord and nerve roots more room, decreases pain, allows one to stand more easily, and improves walking tolerance. ^2-4 It is easily removed and is completely reversible.

X-Stop Features

1. Minimally Invasive/ No Removal of Bone
2. Shorter Procedure/ Faster Recovery & Rehabilitation
3. Local Anesthesia
4. Low Complication Rate
5. Non-fusion, Non-destructive, Reversible
6. Clinically Proven⁵

X-STOP DECOMPRESSES

Before After

The X STOP (“extension stop”) significantly prevents narrowing of the spinal canal and neural foramina in extension2, decompressing the individual degenerative spinal level(s) that provokes symptoms. The dimensions of the spinal canal and lateral neural foramen change significantly after placement of the device.

X STOP PRESERVES MOST STRUCTURE AND SOME MOVEMENT IT IS NOT A FUSION

Before After

Anatomical structures:

1. Supraspinous ligaments
2. Interspinous ligaments
3. No bone-removal:

a. -Direct decompression is not required
b. -Modification of the spinous processes and/or lamina is not required

Kinematics:
1. Extension is limited, flexion remains unchanged
2. Lateral bending and axial rotation remain unchanged¹

Sagittal Alignment:
1. Increases disc height
2. Restores sagittal balance

a. - Forward bending by patient no longer necessary
b. - Patients resume normal posture

Preserves Treatment options:
1. All alternative surgical options are still open; all of the original anatomy is intact

THE X-STOP UNLOADS THE PRESSURE ON THE NERVES

X-STOP redistributes spinal loading.^3,4 It unloads:

1. The posterior annulus pressure by 63% on average.
2. The posterior nucleus pulposus pressure 41% on average
3. The facet force by 68% on average

The X-STOP procedure offers several benefits compared to traditional surgery:

1. Safe and accurate / No risk to neural elements
2. Can be performed under local anaesthesia
3. Performed as same-day or short-stay routine

X STOP implant is constructed with a Titanium alloy body and a PEEK-OPITIMA® spacer.

1. Implant body of Ti-alloy:

a. Non-allergenic
b. Reliable
c. Superior fatigue performance
d. Excellent wear and impact resistance
e. Stiffness similar to cortical bone
f. Radiolucency
g. Resistance to effects from radiation
h. Stiff when wanted - at physiologic loading the X-STOP performs as a spacer
i. Flexible when needed - at excessive loads the X-STOP acts as a shock absorber

X-STOP INDICATIONS

The X-STOP is indicated for:

1. Neurogenic Intermittent Claudication (NIC; leg/buttock/groin pain that is relieved when the spine is flexed such as when sitting in a chair), due to Central and/or Lateral-Recess Lumbar Spinal Stenosis.
2. Spondylolisthesis up to grade 1.5 (of 4) (~35%), with NIC.
3. Baastrup’s Syndrome / ‘Kissing Spine’.
4. Axial-load induced back pain.
5. Facet Syndrome.
6. Degenerative and/or Iatrogenic (post-discectomy) Disc Syndrome.
7. Contained HNP.
8. Unloading of disc adjacent to a Lumbar Fusion Procedure, primary or secondary.

X-STOP REFERENCES

1. Lindsey DP, Swanson KE, Fuchs P, et al. The Effects of an Interspinous Implant on the Kinematics of the Instrumented and Adjacent Levels in the Lumbar Spine. Spine, 2003. 28(19): p. 2192-7.
2. Richards J, Majumdar S, Lindsey DP, et al. The Treatment Mechanism of an Interspinous Process Implant for Lumbar Neurogenic Intermittent Claudication. Spine. 2005 Apr 1;30(7):744-9.
3. Swanson KE, Lindsey DP, Hsu KY, et al. The Effects of an Interspinous Implant on Intervertebral Disc Pressures. Spine, 2003. 28(1): p. 26-32.
4. Wiseman C, Lindsey D, Fredrick A, et al. The Effect of an Interspinous Process Implant on Facet Loading During Extension. Spine. 2005 April 15;30(8):903-7.
5. Zucherman JF, Hsu KY, Hartjen CA, et al. A Multicenter, Prospective, Randomized Trial Evaluating the X STOP Interspinous Process Decompression System for the Treatment of Neurogenic Intermittent Claudication: Two-Year Follow-Up Results. Spine. 2005 Jun 15;30(12):1351-1358.

Go to the next chapter on major procedures.

Go to the chapter on medicines and orthotics.