01-03-2013 | US FDA Panel Approves Epilepsy Device

01 March 2013
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A new implanted neurological device which is designed to reduce the frequency of seizures was resoundingly passed by a US FDA advisory panel. 

The members of the panel voted 11-0, with two abstentions, to back the NeuroPace RNS system. When they voted on the devices safety this was passed 12-0. During a 3-month blind trial the system was found to lower the rate of seizures by 37.9% when the device was switched on compared to 17.3% when it was switched off. There were 191 participants in the study. 

The device is surgically placed on the skull and records ectrocorticographic (ECoG) patterns via electrodes. Once implanted the RNS systems delivers short electrical pulses which are designed to interfere with triggers which could lead to seizures. The ECoG recordings can be used by clinicians to access whether the device is successfully minimising seizure frequency, if they determine that it isn't they can adjust the electrical pulses accordingly.

While the members agreed that the trials findings were sufficient to merit agreement they did debate how the collected data was interpreted. They also noted that there was an issue with identifying in which group of patients the device works best. 

Following approval the FDA suggests that two separate studies should be undertaken to further study the devices effectiveness and safety. These studies may also clarify which group the device works best with. The devices manufacturer is offering to extend its current study for a further two years, bringing the total study time to 9 years. 

Source: MedPage Today, February 22, 2013

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