This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: X STOP® Interspinous Process Decompression System (XSTOP)
PMA Applicant: St. Francis Medical Technologies, Inc.
Address: 960 Atlantic Avenue, Suite 102
Alameda, CA 94501
Approval Date: 11/21/05
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/p040001a.pdf
What is it? The X STOP ® Interspinous Process Decompression System (“X STOP”) is used to relieve symptoms of lumbar spinal stenosis, a narrowing of the passages for the spinal cord and nerves. The X STOP® is a titanium implant that fits between the spinous processes of the lower (lumbar) spine. It is made from titanium alloy and consists of two components: a spacer assembly and a wing assembly.
How does it work? The X STOP® implant is placed between the spinous processes of the symptomatic lumbar levels. Spinous processes are the thin projections from the back of the spinal bones to which muscle and ligaments are attached. The X STOP® is designed to limit extension of the spine in the affected area, which may relieve the symptoms of lumbar spinal stenosis.
When is it used? The X STOP® implant is indicated for treatment of patients aged 50 or older suffering from pain or cramping in the legs (neurogenic intermittent claudication) secondary to a confirmed diagnosis of lumbar spinal stenosis. The X STOP® is indicated for those patients with moderately impaired physical function who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of nonoperative treatment. The X STOP® may be implanted at one or two lumbar levels.
What will it accomplish? The X STOP® may relieve some or all of the symptoms of lumbar spinal stenosis and may improve a patient’s ability to function.
When should it not be used? The X STOP® should not be used in patients with:
- an allergy to titanium or titanium alloy;
- spinal anatomy or disease that would prevent implantation of the device or cause the device to be unstable in the body, such as:
- significant instability of the lumbar spine
- an ankylosed segment at the affected level(s)
- acute fracture of the spinous process or pars interarticularis
- significant scoliosis
- neural compression causing neurogenic bowel or bladder dysfunction;
- diagnosis of severe osteoporosis
- active systemic infection or infection localized to the site of implantation.
Additional information: Summary of Safety and Effectiveness and labeling are available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p040001