Preoperative Considerations

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

The X-STOP^® IPD^® Procedure is indicated for patients aged 50 or older who have lumbar spinal stenosis. A diagnosis of lumbar spinal stenosis should be confirmed by a doctor with X-ray, MRI or CT scans. The X-STOP^® 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^® 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^® IPD^® Device may be implanted at one or two levels of the lumbar spine.

Who should not receive it?

The X-STOP^® IPD^® Device 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.

Preparing for Surgery

If you and your surgeon elect to go ahead with the X-STOP^® IPD^® Procedure, there are several things you can do to help you achieve the best possible outcome for your surgery. You can increase the likelihood of a successful outcome by eating well-balanced nutritional meals as far in advance of your procedure as possible. Poor nutrition can reduce the body’s ability to heal itself.

Possible Complications

Spinal surgery is not without risk.

Specific information on the rates of complications for the X-STOP^®IPD^® System and spinal surgery should be discussed with your doctor.

Complications that may be associated with X-STOP^® IPD^® Procedure include, but are not limited to the following:

	implant dislodgement (movement out of place)
	implant not positioned correctly
	fracture of the spinous process
	foreign body reaction (ex. allergic reaction)
	additional surgery, which could include removal of the X-STOP® IPD® Implant
	mechanical failure of the implant

Complications related to any type of surgery may include, but are not limited to, the following:

	reactions to anesthesia
	heart attack
	infection, which could require medication or an operation
	blood vessel damage/bleeding
	bruising (hematoma)
	pneumonia
	blood clots
	wound closure problems
	spinal cord or nerve damage
	pain or discomfort
	paralysis
	stroke
	death

Please consult your doctor about the complication rates related to surgery.