FDA approves cervical disk device

Jul 17, 2007

The U.S. Food and Drug Administration Tuesday announced approval of the first device designed to treat cervical degenerative disc disease.

The Prestige Cervical Disc, manufactured by Medtronic Sofamor Danek of Memphis, is used to treat 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 Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health. "This device will help relieve pain and restore function."

The FDA said current surgical treatments involve removing a diseased or bulging disc in a patient's neck and fusing two or more bony vertebrae. The Prestige Cervical Disc allows the option of replacing the impaired natural disc.

The FDA said it based its approval on the company's laboratory and animal testing, and on its clinical study of 541 patients.

As a condition of approval, the company will conduct a post-approval study during the next seven years to evaluate the longer term safety and effectiveness of the device.

The Prestige Cervical Disc was approved as a class III, or high-risk, device.

Copyright 2007 by United Press International

Explore further: Cardinal Health paying $26.8 million in FTC settlement

Related Stories

Researchers explain skin fusion at a molecular level

13 minutes ago

Scientists from the Goethe University (GU) Frankfurt, the European Molecular Biology Laboratory (EMBL) Heidelberg and the University of Zurich explain skin fusion at a molecular level and pinpoint the specific ...

Online discussion forums good for well-being, study shows

13 minutes ago

A new study has found that internet discussion forums have positive links to well-being and are even associated with increased community engagement offline, contrary to a common perception of them being outdated and prone ...

Study reveals 'two faces' of phytoplankton

15 minutes ago

Phytoplankton, commonly known as plant plankton that remove carbon dioxide from the atmosphere through photosynthesis, are potentially a key driver of Arctic warming under greenhouse warming, a study reveals.

Iron-rich rocks could could hold signs of life

22 minutes ago

A robotic mission's search for life on Mars may seem worlds away from human scientists wandering around hot springs in Yellowstone National Park. But a study of the Yellowstone hot springs has revealed new ...

Recommended for you

Cardinal Health paying $26.8 million in FTC settlement

20 hours ago

Cardinal Health will pay $26.8 million as part of a settlement with the Federal Trade Commission over charges it monopolized the sale in 25 markets of diagnostic drugs known as low-energy radiopharmaceuticals.

Selecting the right tool for the job

Apr 14, 2015

Randomized clinical trials of new drugs have long been considered the "gold standard" in determining safety and efficacy before drugs, biologics, vaccines or devices are introduced to the general public. However, in the case ...

User comments : 0

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.