FDA Approves Implanted Brain Stimulator for Epilepsy

The device helps reduce frequency of seizures, studies show

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Physicians can modify the programming of the device even after it has been implanted, to reflect a patient's needs over time, Fischer said. They can also observe the brain activity of a patient from a laptop computer in their office -- to help them manage a patient's treatment, he said.

Speaking in February at the time of the FDA panel's approval, Fischer said it was too soon to say what the device might cost. However, comparable systems for heart problems range in price from $30,000 to $35,000, not including the cost of the surgery to implant the device. The battery that powers the epilepsy device lasts about three years. When it fails, a new device has to be substituted in a 30-to-60-minute outpatient surgical procedure, Fischer said.

The FDA did note some important safety issues with the RNS System. Users cannot undergo MRI procedures, or other procedures such as diathermy (electrically induced heat), electroconvulsive ("electroshock") therapy or transcranial magnetic stimulation. "The energy created from these procedures can be sent through the neurostimulator and cause permanent brain damage, even if the device is turned off," the FDA explained.

Health issues that could also occur include infections at the site of the implant and premature battery depletion, the FDA said.

More information

For more on epilepsy, visit the Epilepsy Foundation .

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