FDA: Medtronic brain stimulator missed study goal
Washington (AP) — The Food and Drug Administration says a Medtronic nerve stimulating implant failed to significantly reduce seizures in epilepsy patients.
Medtronic Inc. has asked the FDA to approve its Deep Brain Stimulation implant for epilepsy, a neurological disease that causes seizures.
The device is already used to treat other movement disorders, including Parkinson's Disease.
In documents posted online, the FDA says Medtronic's device failed to meet its primary study goal, which was a reduction in seizures after three months in patients with the device compared to those without it.
After Medtronic completed the study, the FDA says the company re-analyzed the data to show a significant reduction.
The FDA will ask a panel to weigh those results this Friday.
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