ROCKVILLE, Md. -- The FDA has approved a stainless steel artificial cervical disc for treatment of cervical degenerative disc disease.
ROCKVILLE, Md., July 17 -- The FDA has approved a stainless steel artificial cervical disc for treatment of cervical degenerative disc disease.
The Prestige Cervical Disc is the first to win FDA approval, said Daniel Schultz, M.D., director of the FDA's Center for Devices and Radiological Health. The agency approved it as a class III device-meaning high risk.
Noting that current surgical treatment requires removing a diseased or herniated disc and fusing vertebrae, Dr. Shultz said that patients will not "have another surgical option for treating this condition."
The new disc consists of two stainless steel pieces that articulate against each another with a ball and trough design. After removal of the impaired natural disc, surgeons attach the artificial disc to adjacent vertebrae with screws.
The agency's approval came after laboratory and animal testing and a 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.
As a condition of approval, the FDA will require the company to conduct a seven-year post marketing study to evaluate longer term safety and efficacy of the device.
The Prestige Cervical Disc is made by Medtronic Sofamor Daneck of Memphis, Tenn.