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: Court clears German safety body in breast implant scare

Related Stories

Research shows 'mulch fungus' causes turfgrass disease

5 hours ago

Inadvertently continuing a line of study they conducted about 15 years ago, a team of Penn State researchers recently discovered the causal agent for an emerging turfgrass disease affecting golf courses around ...

Study on pesticides in lab rat feed causes a stir

7 hours ago

French scientists published evidence Thursday of pesticide contamination of lab rat feed which they said discredited historic toxicity studies, though commentators questioned the analysis.

Experiments open window on landscape formation

7 hours ago

University of Oregon geologists have seen ridges and valleys form in real time and—even though the work was a fast-forwarded operation done in a laboratory setting—they now have an idea of how climate ...

To conduct, or to insulate? That is the question

7 hours ago

A new study has discovered mysterious behaviour of a material that acts like an insulator in certain measurements, but simultaneously acts like a conductor in others. In an insulator, electrons are largely stuck in one place, ...

Recommended for you

Drug and device firms paid $6.5B to care providers

Jun 30, 2015

From research dollars to free lunches and junkets, drug and medical device companies paid doctors and leading hospitals nearly $6.5 billion last year, according to government data posted Tuesday.

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.