GAITHERSBURG, Maryland (Reuters) - A U.S. advisory panel recommended approval of Medtronic Inc.’s Bryan cervical disc as a replacement for worn-out discs in the neck.
The committee of outside experts voted 7-1 on Tuesday to urge the U.S. Food and Drug Administration to clear the device.
The panel said approval should come with several conditions, including asking Medtronic to study some patients with the device for 10 years.
The FDA usually follows panel recommendations.
On Monday the FDA cleared the first artificial disc for the neck, a Medtronic device called Prestige. Other discs are approved for use in the lower back.
The devices are billed as alternatives to spinal fusion surgery, in which surgeons remove a degenerated disc and combine the two adjacent vertebrae. Fusion can relieve pain but restricts movement, while artificial discs are designed to preserve the ability to bend.
Reporting by Lisa Richwine