Dynesys
Spinal System
Overview
Background
Description

Overview
Chronic back and leg pain in the lumbar region, caused by problems with the
intervertebral discs, are usually treated non-invasively for as long
as possible. When such treatment no longer provides relief, the primary
solution until now has included removal of the affected discs and fusion
of the vertebral segments. It is estimated that nearly 400,000 people
in the U.S. undergo spinal fusion procedures each year.
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Background
The first Dynesys device was implanted in Europe in 1994 and has treated
over 9,000 patients. The Dynesys Spinal System has recently been approved
for clinical trials at only 20 spine centers in the United States, including
the Spine Institute of New York. This procedure may provide an alternative
to patients suffering from spondylolisthesis and spinal stenosis, who
previously would have needed spinal fusion surgery to moderate pain from
compressed nerves.
The Spine Institute is one of the twenty hospitals enrolling patients into
this FDA controlled clinical trial to assess the safety and effectiveness
of the Dynesys Spinal System. This new treatment will be compared to the
current standard treatment to see which is more successful.
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Description
The Dynesys system consists
of external spacers made of surgical polyurethane (flexible plastic
tubing) surrounding a polyethylene (nylon-like) cord. The device
is attached to both sides of the vertebrae in the affected area
of the spine, stabilizing the spine without fusing and preserving
its natural curve, which allows the patient a greater degree of
mobility, in addition to reducing the pain caused by excess motion.
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