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FDA staff questions efficacy of Medtronic's device for treating epilepsy
Wednesday, March 10 2010 | Comments
What's This?
Food and Drug Administration staff said Medtronic Inc.'s deep brain stimulation therapy did not meet the efficacy endpoint of a clinical trial of patients with epilepsy whose seizures are not controlled adequately with drugs, according to documents released ahead of a meeting of the Neurological Devices Panel scheduled for March 12.The study included 109 patients who were implanted with Medtronic's device, which uses an implantable neurostimulator to deliver electrical stimulation, bilaterally, to the anterior nucleus of the thalamus in the brain. The device was activated in half of the patients, with treatment assignments (activation vs. no activation) determined in a randomized fashion.
The agency staff said the device failed to reach the prespecified primary efficacy endpoint, which was reduction in seizure rate in the active group greater than that in the control group during the blinded phase of the study.
In separate documents posted on the FDA's Web site, Medtronic said an alternate analysis that removed the results of an "outlier" subject who had a high number of seizures "confirms the statistically significant difference between the active and control groups at the end of the blinded phase."
The FDA staff also asked the panel to consider if the device is safe given reports of death and suicidal behavior in the trial.
Medtronic said "no unanticipated adverse device effects" were seen in the study. The company noted that the deaths were not considered related to the device and added that depression is a common comorbidity in patients with refractory epilepsy.
The company is seeking approval of the device for treating patients with medically refractory epilepsy with partial-onset seizures.
The device is currently approved to treat Parkinson's disease, essential tremor and dystonia.
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