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Lower Back: X-Stop® Spacer

What is the X-STOP Spacer?

The X-STOP Spacer is the only interspinous spacer approved by the FDA in the United States to treat the symptoms of lumbar spinal stenosis (LSS). LSS is the most common reason for back surgery in people aged 65 years and older in the United States.¹ An estimated 6 million Americans suffer from LSS, with approximately 1.4 million being diagnosed annually.²

Approximately half of the patients who received the X-STOP Spacer in a two-year research study experienced a degree of pain relief and ability to increase their activity levels that was sufficient to be considered a successful outcome at two years after the surgery.³ The clinical benefit beyond two years has not been measured.

Am I an Appropriate Candidate for the X-STOP System?

The X-STOP System is indicated for patients aged 50 or older who have LSS. A diagnosis of LSS should be confirmed by a doctor with X-ray, MRI or CT scans. The X-STOP System is indicated for patients with moderately impaired ability to function, who experience relief from their pain symptoms when bending forward. Patients receiving the X-STOP Spacer should have already been under a doctor's care and getting nonsurgical treatment for their symptoms for at least 6 months. The X-STOP Spacer may be implanted at one or two levels of the lumbar spine.

The X-STOP System should not be used if you have:

• an allergy to titanium or titanium alloy
• spinal anatomy that would prevent implantation of the device or cause the device to be unstable in your body
• cauda equina syndrome, which is a spinal nerve compression that causes bowel or bladder dysfunction
• bone fractures or a diagnosis of severe osteoporosis
• an infection in your blood or anywhere near your lower back where the surgery is planned.

1. Ciol MA, Deyo RA, Howell E, Kreif S. An assessment of surgery for spinal stenosis; time trends, geographic variations, complications and reoperations. J Am Geriatr Soc 1996:44:285-90.

2. US Census data and "Prevalence of Symptoms of Cervical and Lumbar Stenosis Among Participants in the Osteoporotic Fractures in Men Study" (Vogt, et al) SPINE 2006 Vol.31, Num 13, pp. 1445 - 1451

3. Zucherman JF, Hsu KY, Hartjen CA, Mehalic TF, Implicito DA, Martin MJ, Johnson DR 2nd, Skidmore GA, Vessa PP, Dwyer JW, Puccio ST, Cauthen JC, Ozuna RM. 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):1351-8.

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