Medtronic's Prestige Cervical Disc launched in US.

In July, Medtronic Sofamor Danek received FDA approval for its Prestige Cervical Disc, the first device designed to treat cervical degenerative disc disease, one of the most common causes of neck and arm pain, as well as the first artificial disc approved for use in the neck. It previously was only available in Europe. In addition, the FDA also recommended approval for the company's Bryan Cervical Disc, a polyurethane and titanium motion-preservation implant.

The Memphis, TN-based company's Prestige Disc, a stainless steel device, was approved as a Class II device. It came on the heels of the company's completion of a clinical study of 541 patients.

"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, director of the FDA's Center for Devices and Radiological Health. "This device will help relieve pain and restore function."

Current surgical treatments involve spinal fusion procedures, whereas this new device involves replacing the impaired natural disc.

As part of the FDA's approval, Medtronic agreed to conduct a seven-year post-approval study to evaluate the long-term safety and efficacy of the device. In addition, the company will hold a five-year enhanced surveillance study.

The FDA panel that reviewed Medtronic's Bryan Disc recommended approval based, in part, on results from a prospective, randomized, controlled clinical trial of more than 450 patients that showed significant improvements in its outcome measures. Next up for the company is an FDA review of Medtronic's premarket approval application for the implant.