X-STOP IPD System - Preoperative Considerations

Patients

Preoperative Considerations

Are you a candidate for the X-STOP^{PK ®} IPD^® Procedure?

The X-STOP^{PK ®} Interspinous Process Decompression procedure is indicated for patients who have mild to moderate lumbar spinal stenosis. A diagnosis of lumbar spinal stenosis should be confirmed by a doctor.

The X-STOP^PK^® IPD^® procedure 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^PK^® IPD^® procedure should have already been under a doctor's care and getting non-surgical treatment for their symptoms for at least 6 months.

The X-STOP^PK^® device may be implanted at one or two levels of the lumbar spine.

Who should not receive it?

The X-STOP^PK ^® device should not be used if you have:

Has unremitting pain in any spinal position.
Has cauda equina syndrome defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder (bladder retention or incontinence) dysfunction.
Has significant scoliosis (Cobb angle greater than 25°).
Has isthmic spondylolisthesis. Has degenerative spondylolisthesis greater than grade 1.5 (on a scale of 1 to 4) at the affected level.
Has sustained pathologic fractures of the vertebrae or multiple fractures of the vertebrae and/or hips.
Is obese, Body Mass Index (BMI) greater than 40kg/m2. BMI is determined by: [weight (kg) / height (cm) / height (cm)] X 10,000.
Has Paget’s disease at the involved segment or metastasis to the vertebrae.
Has an active infection.
Has spinal anatomy such as an ankylosed segment that would prevent implantation of the device or whose spinal anatomy would result in the device being unstable after implantation.

Understanding the risks

As with any surgical procedure, there are potential risks. The procedure is designed to avoid these risks as much as possible, but there is a chance that complications may occur.
You and your doctor should discuss the possible risks associated with this treatment and if this treatment is right for you.
Please note that not all patients will benefit from this procedure. Only your doctor can determine the appropriate treatment for your individual condition.