Physician/researcher votes on FDA panel approving epilepsy neurostimulator
Jose Cavazos, M.D., Ph.D., joins unanimous vote
SAN ANTONIO (March 4, 2013) — Jose Cavazos, M.D., Ph.D., professor of neurology, pharmacology and physiology at the UT Health Science Center San Antonio and physician with UT Medicine San Antonio, recently approved – as a member of the Neurological Devices Panel of the U.S. Food and Drug Administration Medical Devices Advisory Committee – the NeuroPace RNS System for neurostimulation use in epilepsy.
During a daylong meeting Feb. 22, the panel heard study results from NeuroPace Inc. representatives, presentations from the FDA, and testimonials from patients and families. The 13 voting members determined the evidence shows the devise is safe and effective in patients with partial-onset epilepsy in whom other antiepileptic treatment approaches have failed and that the benefits outweigh the risks.
Dr. Cavazos said the study population consists of patients with very intractable epilepsy and thus may not exactly be “real world.” He agreed there are subgroups who respond better to the device and post-market studies need to be done to determine who these responders are.
Dr. Cavazos did not participate in the studies and does not have an interest in the company.
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