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Join Date: Jun 2004 Location: PA
Posts: 128
| Re: Artificial disc for cervies
I found this article on the approval of the artificial disc, but I think too it is only for one level and this one is for the lumbar. I traveled far and wide this summer in search of an artificial disc. I was not considered a candidate because of multi-level disease. I have heard they are doing two level, but not three.
http://www.prnewswire.com/cgi-bin/s...0002311230&EDATE=
New Motion Preserving Device Offers Alternative to Spinal Fusion Surgery
RAYNHAM, Mass., Oct. 26 /PRNewswire/ -- The U.S. Food and Drug
Administration (FDA) has approved the CHARITE(TM) Artificial Disc, a device
that treats severe low back pain by replacing a damaged or worn out spinal
disc with an artificial one. The approval was announced today by DePuy Spine,
Inc., a Johnson & Johnson company, the manufacturer of the disc.
While artificial replacements are commonly used in hips and knees, this is
the first FDA approval of such a device for spinal discs.
"The CHARITE Artificial Disc has the potential to revolutionize spine
surgery," said Scott Blumenthal, M.D., principal investigator in the CHARITE
Artificial Disc clinical trial and an orthopaedic spine surgeon from the Texas
Back Institute in Plano. "Until now, spine surgery relieved pain by limiting
motion. Now, for the first time, we can relieve pain and preserve motion."
The CHARITE Artificial Disc is a high-tech device made of two metallic
endplates and a movable high-density plastic center that, once implanted, is
designed to help align the spine and preserve its ability to move. Spinal
discs maintain the position of the spine and allow for the flexibility to bend
and twist.
Lumbar spinal fusion surgery, a common surgical treatment for low back
pain or degenerative disc disease, is often effective in reducing pain, but
limits range of motion and may transfer extra stress to discs above and below
the fusion site. More than 200,000 of these procedures are performed each
year in the U.S.
In clinical trials comparing artificial disc replacement to spinal fusion
surgery, CHARITE Artificial Disc patients maintained flexibility, experienced
improvements in pain and function, left the hospital sooner and were more
satisfied with the procedure. Complication rates for both groups of patients
were similar.
CHARITE Artificial Disc Patients Return to Work Sooner
According to John Regan, M.D., a spine surgeon at Cedars Sinai in Los
Angeles and a clinical investigator, CHARITE Artificial Disc patients were
able to return to work and normal activity sooner than his spinal fusion
patients.
"At our center, CHARITE Artificial Disc patients returned to work in 12
weeks or less, which was far better than the spinal fusion patients who were
not able to go back to work for about six months," said Dr. Regan.
How the CHARITE Artificial Disc Procedure is Performed
Typically, two surgeons work together in performing the operation. A
general or vascular surgeon approaches the spine through an incision in the
abdomen and carefully moves internal organs and blood vessels out of the way
to provide access to the spine. A spine surgeon then uses special tools to
remove the damaged disc and creates a space between two vertebrae for the
implantation of the artificial disc. The procedure generally takes one to two
hours.
In spinal fusion surgery a damaged spinal disc is removed and vertebrae
are joined together using bone grafts and metal screws and/or cages so that
motion can no longer occur in this area of the spine. Patients usually have
to wear a brace for about three months after surgery.
Not for Everyone, Talk to Your Doctor
Artificial disc replacement is not for everyone. As with any major
surgery, there are possible complications that can occur including unresolved
pain, allergic reactions, bladder problems and/or infection. Patients should
ask their doctors to see if artificial disc replacement is appropriate for
them.
More information about the CHARITE Artificial Disc is available at
http://www.charitedisc.com or by calling 1-866-DISC523. These resources also
provide information that will help consumers find a doctor in their area who
has been trained in artificial disc replacement.
Currently, there are 15 spine centers throughout the U.S. who offer disc
replacement with the CHARITE Artificial Disc. Many more centers are expected
within the next several months as surgeons receive extensive training in the
procedure. Patients may have to wait several weeks or months while surgeons
complete this mandatory training.
Surgeon Training is Top Priority
DePuy Spine is sponsoring a comprehensive training and education program
for surgeons. The program is a combination of hands-on surgery, consultation
and visitation with top spine surgeons, lectures and web-based educational
materials. Much of the training will take place at The Center for Spine
Arthroplasty at the Endo-Surgery Institute. More than 50 regional training
centers throughout the country will also provide training.
"Training is critical to the appropriate and effective use of the CHARITE
Artificial Disc and it will be our top priority," said Earl R. Fender,
Worldwide President, DePuy Spine. "Many leading spine surgeons are involved
in the design and conduct of the training program to ensure surgeons have the
required skills for this advanced surgery."
Back Pain One of the Most Common Problems
About 65 million Americans suffer from low back pain every year, according
to the American Association of Neurological Surgeons (AANS). Americans spend
about $50 billion each year on low back pain, the most common cause of job-
related disability and lost work days.
The CHARITE Artificial Disc is also available in more than 30 countries
throughout Europe, Asia, North America, Africa and Latin America.
About DePuy Spine
DePuy Spine, a Johnson & Johnson company, has worked and partnered with
leading clinicians, researchers, and thought leaders to develop products to
treat spine disorders for over 20 years. Today, DePuy Spine stands in the
forefront of the worldwide spine market, with a substantial sales organization
in the U.S. and an expanding worldwide distribution network. The company is
committed to advancing the knowledge of all health care professionals and
their patients in addressing spinal pathologies.
SOURCE DePuy Spine, Inc.
Web Site: http://www.charitedisc.com
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