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Senior Citizen Health & Medicine
FDA Approves First Medical Device to Treat Cervical
Degenerative Disc Disease
Condition can result from trauma, infection, or
natural processes of aging
 July 17, 2007 - The first artificial cervical
(neck) disc for the treatment of cervical degenerative disc disease, one
of the most common causes of neck and arm pain for aging senior
citizens, was approved for marketing today by the Food and Drug
Administration. This Prestige Cervical Disc is made by Medtronic Sofamor
Danek of Memphis.
Degenerative disc disease can result from trauma,
infection, or the natural processes of aging.
"The approval of this artificial disc means that
people with cervical degenerative disc disease now will have another
surgical option for treating this condition," said Daniel Schultz, M.D.,
director, Center for Devices and Radiological Health, FDA. "This device
will help relieve pain and restore function."
The cervical spine (neck region) consists of seven
bones (called the vertebrae), which are separated from one another by
intervertebral discs. These discs allow the neck to bend and rotate.
The current surgical treatment involves removing a
diseased or bulging disc in a patient's neck and fusing two or more bony
vertebrae. The Prestige Cervical Disc would instead replace the impaired
natural disc.
The PRESTIGE Cervical Disc consists of two main
pieces of stainless steel that articulate against one another with a
ball and trough (groove)
- see photo above.
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About degenerative disc disease |
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Disc degeneration is a natural part of aging and
over time all people will exhibit changes in their discs consistent with
a greater or lesser degree of degeneration. However, not all people will
develop symptoms. In fact, degenerative disc disease is quite variable
in its nature and severity. – SpineHealth.com
The phrase "degenerative changes" in the spine
refers to osteoarthritis of the spine. Osteoarthritis is the most common
form of arthritis. Doctors may also refer to it as degenerative
arthritis or degenerative joint disease.
Osteoarthritis may affect any joint in your body.
When it affects your back, it causes slow deterioration of the disks
between the bones (vertebrae) in your spine. This results in narrowing
of the spaces between the vertebrae. Bone spurs often form. When bone
surfaces rub together, the vertebral joints (facets) and areas around
the cartilage become inflamed and painful. Gradually, your spine
stiffens and loses flexibility. Once these changes appear on X-rays,
osteoarthritis has already started.
If you have osteoarthritis, your doctor will work
with you to develop a treatment and pain management plan, which may
include exercise, medications and measures to protect your joints. Your
doctor may also refer you to a rheumatologist, physical therapist or
orthopedic surgeon. – Mayo Clinic
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After a doctor removes the
impaired natural disc, the artificial disc is attached to the adjacent
vertebrae with bone screws.
FDA based approval on the company's laboratory and
animal testing, and on its clinical study of 541 patients. The clinical
study showed that the device improved neck and/or arm pain, and was as
safe and effective as cervical fusion, a common treatment for
degenerative disc disease. The approval decision also took into account
the recommendations of the Orthopedic and Rehabilitation Devices Panel
of FDA's Medical Devices Advisory Committee, which reviewed the product
in September.
As a condition of approval, the company will
conduct a post-approval study over the next seven years to evaluate the
longer term safety and effectiveness of the device. FDA will continue to
monitor the device as part of the agency's overall effort to ensure that
products remain safe and effective once they reach the marketplace.
FDA approved the PRESTIGE Cervical Disc as a class
III device under the pre-market approval process. FDA's regulation of
medical devices is risk-based, with devices classified into low-risk
(class I), moderate-risk (class II), or high-risk (class III)
categories. The FDA regulatory program includes requirements for
registration and listing of products, for high-quality production using
good manufacturing practices and for post-market reporting of adverse
events.
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