In a seven to five decision, a panel of neurology experts are recommending a the Food and Drug Administration approve Medtronic's deep brain stimulation device to reduce seizures in epilepsy patients.
But the recommendation comes with much concern on the effectiveness of the device.
The Neurological Devices Advisory Panel based its approval on Medtronic's study of 110 patients who failed to respond to at least three anti-epilepsy drugs. They were given the deep brain stimulation system, a pacemaker-shaped device which is implanted in the patient's chest. Wires from the device are threaded through the neck into the brain.
Half of the patients in the double-blind study had the device turned on, and half didn't.
The study failed to meet its primary efficacy goal, which was to demonstrate that patients implanted with the deep brain stimulator had significantly fewer seizures than those who received an inactive device after three months.
Such a narrow vote from an advisory committee is not generally considered an endorsement for a drug or device. The FDA doesn't have to follow the advice of its advisory committees, but it usually does.
Medtronic's deep brain stimulation device is already approved to treat other neurological disorders, including Parkinson's disease, and more than 6,000 people in the U.S. have had the device implanted in the past decade, according to FDA briefing documents.