FDA: Medtronic brain stimulator missed study goal

WASHINGTON — The Food and Drug Administration said Wednesday a nerve stimulating implant from Medtronic failed to significantly reduce seizures in epilepsy patients.
Medtronic Inc., the world's largest medical device maker, 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, and more than 6,000 people in the U.S. have had the device implanted in the past decade.
But in documents posted online, the FDA said 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.
Medtronic attributed the missed study goal to one patient, who experienced a massive percent increase in seizures in the month after implantation.
When Medtronic excluded this patient from their analysis, the study achieved a 2.5 percent reduction in seizures. That compared to a 2.3 percent reduction in seizures when the outlier patient was included.
The FDA will ask a panel of neurologic experts on Friday whether the company's results are "clinically significant." The FDA is not required to follow the group's advice, though it often does.
The agency will also ask its experts about negative side effects reported in Medtronic's study, including depression, anxiety and memory problems.
Medtronic's Deep Brain Stimulation device is a pacemaker-shaped device surgically implanted in the chest. Wires from the device are threaded through the neck into the brain, where they stimulate areas used for coordination and movement.
The current standard of treatment for epilepsy is medication or surgery to remove parts of the brain thought to trigger seizures. However, the drugs have limited effectiveness, and some patients are too frail for brain surgery.
Rival medical device maker Cyberonics Inc. markets its own nerve stimulator for epilepsy, but many patients do not respond to the therapy.
"There is large unmet need for patients who have these terrible seizures, sometimes 50 or more a day, and they need help," said Dr. Michael Kaplitt, of New York Presbyterian Hospital. Kaplitt helped conduct Medtronic's study of the device.