After long trials of deliberation, Medtronic’s Bryan Cervical Disc became FDA-approved on May 12, 2009. The Bryan Cervical Disc, designed to alleviate neck pain and related disability caused by degenerative disc disease, had received a favorable FDA recommendation back in July of 2007.
Although approved, conditions have been put in place for the approval of the Bryan for the next ten years. Medtronic will be conducting a post-market study, which will include tracking of patients' neck disability index scores, radiographic information, neurological status and a number of other outcomes in addition to data on adverse events and explanted devices.
What is unique about the Bryan is it is designed to better mimic natural disc shock absorption. It is made of titanium and polyurethane, which is softer than the nuclei of competitive discs, such as the Prestige’s metal on metal design. The polyurethane in the Bryan raised questions on wear debris during the FDA panel, but was determined to not be an issue for short-term use. Long-term use is an area of concern though, and will be under surveillance.
The Bryan (Medtronic), Prestige (Medtronic) and ProDisc-C (Synthes) are the only cervical artificial disc replacement options for the U.S., although there are expected to be more approvals and launches soon. At this point, Medtronic has not commented on the Bryan’s approval, or on projected launch dates when it will be commercially available.
Medtronic Receives FDA Approval -- Medical News Today