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Alum’s Product Recommended for FDA Approval

Alum's Product Recommended for FDA ApprovalFebruary 22, 2013

Brett Wingeier (BS, MS, PhD) has spent twelve years developing an implanted neurological device that is intended to reduce the frequency of epileptic seizures. At a meeting today, his company's product gained the unanimous backing of an FDA advisory panel.

Wingeier is the Principal Biomedical Engineer at NeuroPace, Inc. in Mountain View, CA. Today, members of the Neurological Devices Panel of the FDA's Medical Devices Advisory Committee, meeting in Silver Spring MD, voted 11-0, with two members abstaining, to recommend approving the NeuroPace RNS System. The RNS System lowered the rate of seizures by 37.9% during a 3-month blinded evaluation period when turned on, compared with 17.3% when not turned on (P=0.012), results of a randomized, double-blinded, sham-controlled trial of 191 people showed. The device is surgically implanted under the skin on the skull and records electrocorticographic (ECoG) patterns via electrodes. The device delivers short electrical pulses intended to interrupt the triggers in the brain that cause epileptic seizures.

It is designed specifically for people aged 18 and older with partial-onset epilepsy, which occurs when one or more fixed locations in a person's brain start the cascade of nerve firing that creates a seizure.

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