FDA panel recommends approval of NeuroPace's anti-epilepsy implant

February 22, 2013 by Ingrid Mezo

NeuroPace makes progress in its years-long road to FDA approval with near-unanimous approval for its RNS neurostimulation therapy for epileptic seizures.


California neurostimulation devices maker NeuroPace crept 1 step closer to an FDA win for its epilepsy implant with near-unanimous approval from the FDA's Neurological Devices Advisory Panel.

The expert panelists today voted unanimously that the RNS implantable neurostimulator demonstrated safety in clinical trials, 12 of 13 voted that the device demonstrated reasonable effectiveness, and 11 of 13 voted that the benefits outweigh the risks. There were no negative votes from the panel, with 1 member abstaining on the question of effectiveness and 2 abstaining from the question of the risk-benefit ratio.

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NeuroPace hopes to win FDA approval for the 1st-of-its-kind RNS system is as an adjunctive therapy to reduce the "frequency of seizures in individuals 18 years of age or older with partial onset seizures from no more than 2 foci that are refractory to 2 or more anti-epileptic medications," according to the company.

The RNS device is surgically implanted in the cranium where it senses and records electrocorticographic (ECoG) patterns from intra-cranial electrodes. The device delivers short trains of electrical energy to the brain in order to interrupt dangerous activity indicative of a seizure.

The RNS implant's detection and stimulation parameters can be tuned to optimize seizure control against stimulation-related side effects, and the device can be programmed using a wide range of different detection algorithms and responsive stimulation outputs, the FDA noted.