|
The X-STOP
Interspinous Process
Distraction System (IPD)
St. Francis
Medical Technologies, Inc. (SFMT) was founded to develop new, minimally invasive
technologies for use in spinal surgery. The Company’s first product is a
non-fusion implant, called the X STOP® Interspinous Process Decompression (IPD)
System. The X STOP is the world’s only minimally invasive implant system
designed to treat degenerative lumbar spinal stenosis (LSS).
Clinically,
the X STOP offers efficacy comparable to decompressive laminectomy with and
without fusion, with a safety profile similar to conservative, non-operative
care.
Biomechanically, the X STOP prevents spinal canal narrowing, reduces disc
pressure, reduces loading to the facets and limits extension without
significantly affecting adjacent levels, or limiting healthy spinal motion.
The X STOP
is a revolutionary alternative to the common procedures performed today for
lumbar spinal stenosis, degenerative disc disease and spondylolisthesis.
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 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
|
