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The U.S. Food and Drug Administration
(FDA) has announced that it has approved
for marketing the Prestige Cervical
Disc, made by Medtronic Sofamor Danek
of Memphis—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.
“
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 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) http://www.fda.gov/cdrh/pdf6/p060018.jpg.
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.
Media Inquiries: Kris Mejia, 301-827-6242,
kristine.mejia@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA |
