For Release: 7:00 am EST
on December 12, 2007
Central Texas Spine Institute Successfully Completes First Anatomic
Facet Replacement System Implantation
Austin, Texas (December 12, 2007) – Central Texas Spine
Institute announced today
that a patient diagnosed with severe lumbar spinal stenosis was
successfully implanted
with the Anatomic Facet Replacement System (AFRS™).
This was the first patient in the
state of Texas to receive this new technology. The surgery
was performed as part of an
FDA Investigational Device Exemption (IDE) pilot study at
Central Texas Spine Institute
by spine surgeon, Randall Dryer, M.D.
The AFRS™ is the first facet joint replacement device
anatomically designed to provide
lumbar spinal stenosis and facet degeneration patients with
an alternative to spinal
fusion. A fusion uses metal rods and screws to join vertebrae
together. While most
patients report pain relief after a spinal fusion, the surgery
often eliminates flexibility
and range of motion, and can cause unnecessary wear on other
spinal levels. By
contrast, the AFRS™ is designed to mimic normal motion
and prevent adjacent level
degeneration.
The AFRS™ is made of two highly polished cobalt chrome
implants that articulate similar
to other total joints that have been used successfully in hip
and knee replacements for
several decades.
Dr. Dryer, a board certified orthopedic spine surgeon and principal
investigator for the
AFRS™ IDE study said, “Spinal stenosis afflicts
more than 400,000 Americans and is the
most common indication for surgery on patients over the age
of 60. With the
development of new anatomically designed total facet joint
devices (AFRS™), I now
have a clear alternative for my spinal stenosis patients who
may have otherwise
received a fusion.”
The results of the AFRS™ study
will be submitted to the FDA to support the approval of
the device in the United States. In Europe, the AFRS™ has
already obtained a CE Mark
and is approved for use.
Central Texas Spine Institute is one of eight centers in
the U.S. involved in this study.
They invite patients who are interested in learning more
about the AFRS™ clinical trial to
visit www.stenosisrelief.com.
To determine if they are eligible to participate in the trial,
patients can also call CLINICAL TRIAL RECUITING HAS CLOSED.
*Note: AFRS™ is an investigational device in the United
States. It is limited by United
States (U.S.) Federal Law for investigational use only.
About Central Texas Spine Institute, LLP
Central Texas Spine Institute, located in Austin, Texas,
offers comprehensive diagnostic
and treatment options for problems of the neck (cervical
spine) and low back (lumbar
spine). Our fellowship-trained specialists utilize
the latest technology, coupled with years
of experience, to diagnose and treat spinal disorders.
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Press Contact
James Gdula
Administrator
Central Texas Spine Institute
512 795-2225
jgdula@spine-ctsi.com
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