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For Release: 7:00 am EST on December 12, 2007


Central Texas Spine Institute Successfully Completes First ACADIA™ 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 ACADIA™ Facet Replacement System (ACADIA™). 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 ACADIA™ 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 ACADIA™ is designed to mimic normal motion and prevent adjacent level degeneration.

The ACADIA™ 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 ACADIA™ 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 (ACADIA™), I now have a clear alternative for my spinal stenosis patients who may have otherwise received a fusion.”

The results of the ACADIA™ study will be submitted to the FDA to support the approval of the device in the United States. In Europe, the ACADIA™ 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 ACADIA™ 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: ACADIA™ 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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