Medtronic received long-awaited FDA approval for its Bryan cervical disc on May 12. The device received a favorable FDA panel recommendation in July of 2007, just a day after Medtronic’s Prestige disc was approved for market launch. Under the conditions for Bryan’s approval, Medtronic will conduct a 10-year post-market study tracking 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.
The Bryan is made from titanium and polyurethane, which is softer than the nuclei of competitive discs and designed to better mimic natural disc shock absorption. The polyurethane raised questions on wear debris during the FDA panel, and though it was found not to be an issue in the short-term, it would require long-term surveillance. In comparison, the Prestige is metal on metal, and Synthes’ ProDisc-C is metal on polyethylene.
Bryan will join the Prestige and ProDisc-C to round out the current U.S. cervical disc offering, which is anticipated to expand to include devices from LDR, NuVasive and others. Medtronic has not commented on the Bryan’s approval nor on projected launch dates. In the approval letter, the FDA said Medtronic would have to provide a PMA amendment with updated product labeling before the device is distributed commercially.
BY JOHN MCCORMICK, MAY 29, 2009
