The Food & Drug Administration is requiring manufacturers of dynamic stabilization systems to run post-market studies examining fusion rates and the frequency of additional surgeries after implantation.
The federal safety watchdog said the systems, which use pedicle screws to stabilize spinal vertebrae, are designed to fortify the spine while fractured or otherwise damaged vertebrae heal. The systems are meant to allow some flexibility during the fusing process, compared with older systems that fix the spine in place and allow for no movement.
“Currently, there is not enough clinical data to determine whether these dynamic stabilization systems provide enough spinal stability to allow for complete spinal fusion, as the system components may loosen, bend, or break over time. If fusion does not occur, a patient’s condition could worsen and possibly require additional surgical procedures,” the FDA said in a press release.
Besides the new post-market requirements for existing systems, the agency is also requiring makers of new products to supply additional data along with their approval submissions.
No changes are expected regarding how the devices may be used, at least until it’s had a chance to review the data, the agency said.
The 16 manufacturers of already-approved systems must design and implement studies to examine:
- The fusion rate for dynamic stabilization systems compared to traditional stabilization systems;
- The incidence rate, severity and time course of adverse events for dynamic stabilization systems compared to traditional stabilization systems;
- The type, incidence rate and time course of subsequent surgical procedures for dynamic stabilization systems compared to traditional stabilization systems;
- And the cause of failure for dynamic stabilization systems based on analysis of all reasonable available systems that have been removed from patients, along with any association between the patient’s demographic and clinical data and the device failure.
The new requirement is the latest sign that the FDA’s new regime plans to hold medical device makers to a higher standard. In August, new commissioner Margaret Hamburg said the agency would step up its enforcement efforts and act more quickly in cases where public health might be at risk.
The agency will have more resources to implement that plan, as well, after the U.S. Congress approved a $373 million, 14 percent budget boost for 2010.
