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FDA Panel to Consider Brain Stimulator for Epilepsy
Date:2/21/2013

he brain causes surges of energy that can cause a person to have muscle contractions or to black out.

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.

On Friday, members of the FDA panel will listen to a presentation by NeuroPace and hear from members of the public; they will also ask specific questions of company officials.

By the end of the day, the panel is expected to vote on whether to recommend that the device be approved. The FDA does not have to follow the recommendations of its expert panels, but it typically does.

Representatives of the Epilepsy Foundation will also comment on the need for innovative treatments for the disease, but they will not speak for or against approval of the product.

"We're not in a position to evaluate everything that an evaluating committee would be looking at, but we do advocate for access to treatments once they're FDA-approved," explained Angela Ostrom, vice president of public policy and advocacy for the Epilepsy Foundation, based in Landover, Md.

While Fischer said it is too soon to say what the device might cost, 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 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.

Fischer said the company has spent 15 years developing the device.

More information

For more on epilepsy, see the Epilepsy Foundation .

SOURCES: Frank Fischer, president and CEO, NeuroPace, Mountain
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