SPINE DOCTOR - Surgery

The X STOP Interspinous Process Distraction System (IPD)

For the Treatment of Lumbar Spinal Stenosis

Immediate and lasting relief of symptoms from lumbar stenosis with less cost and less morbidity

Decompressive surgery is the only surgical treatment available for symptomatic lumbar spinal stenosis (LSS). While clinical results can be satisfactory, patients require a long period of recovery and the surgery can result in a high rate of perioperative and postoperative complications. Because many stenosis patients are elderly, they may suffer from co-morbid conditions that can significantly increase their risk of complications.

Now there is a new surgical treatment for symptomatic lumbar spinal stenosis. For patients who suffer from symptoms at one or two contiguous levels, obtain relief from symptoms while sitting and who experience leg pain more than axial back pain, the X STOP IPD offers immediate and long-term relief of symptoms:

without the removal of any bone or soft tissue
without general anesthesia
without lengthy postoperative recovery
without the risk of significant complications
without significant costs

The X STOP Patented Design
The unique design of the X STOP allows it to be easily and quickly inserted, yet ensures it will remain safely and permanently in place without attachment to the bone or ligaments. The wings prevent forward and side-to-side movement while the supraspinous ligament prevents backward displacement.

The X STOP oval spacer swivels, making it self-aligning relative to the uneven surface of the spinous process. This ensures that no sharp edges come into contact with the spinous process and that compressive loads are distributed equally on the surface of the bone. X STOP is made of high strength titanium alloy and is available in five convenient diameters, 6 mm, 8 mm, 10 mm, 12mm and 14 mm, to meet the anatomical requirements of every patient.

The X STOP is comprised of two major parts:
the Main Body (with oval spacer & tissue expander) A the Universal Wing B

X STOP IPD: a revolutionary new therapy
Interspinous Process Distraction represents a significant breakthrough in the treatment of LSS. The X STOP is placed between the spinous processes of the symptomatic disc levels. This distracts the space and maintains it in a slightly flexed position, allowing patients to resume their normal posture rather than flex the entire spine to gain relief of symptoms. The X STOP IPD System incorporates the normal anatomy of the spine into a dynamic structure that prevents extension of the stenotic segment, preventing nerve root impingement.

The X STOP Interspinous Process Distraction System (IPD) For the Treatment of Lumbar Spinal Stenosis

An Elegant Yet Simple Solution to a Significant Clinical Problem

The size of the spinal canal changes with posture. The area can increase as much as 50% from extension to flexion. With extension, such as occurs during standing and walking, there is narrowing of the spinal canal that results from disks bulging posteriorly and from buckling of the ligamentum flavum. When the spine is flexed, the size of the spinal canal increases significantly.

The principal behind the X STOP (eXtension-STOP) is that by distracting the affected spinal segment and maintaining it in a slightly flexed position (and also preventing extension,) the symptoms of lumbar spinal stenosis can be relieved. In addition, it allows the patient to resume their normal posture rather than flex the entire spine.

Flexion Extension Myelongram Depicting Changes in Canal Volume.

Lumbar Spinous Processes High Breaking Strength / Low In Vivo Loads

The X STOP implant is designed to be placed between the spinous processes of the affected level(s). By placing the stenotic segment in slight flexion and by preventing extension, The X STOP relieves the symptoms of lumbar spinal stenosis.

Biomechanical tests confirm the ability of the spinous processes to support the X STOP even in patients with osteoporosis. The ratio of the breaking strength of the spinous process to the expected in vivo loads is almost 10 to 1.

Spinous Process Loading Characteristics In Vitro

The X STOP device is classified as an investigational device, under an Investigational Device Exemption issued by the U.S. Food and Drug Administration.