October 22, 2014

FDA panel meets today to discuss the Medtronic brain stimulator for use in epilepsy patients



Those living with epilepsy and other seizure disorders will have to wait a little longer to find relief with Medtronic’s brain stimulator.  The stimulator is akin to a pacemaker that is placed in the chest and sends pulses to the brain.  Medtronic has been seeking approval from the Food and Drug Administration to use the device as a treatment option for certain epilepsy patients.  It is already being used for Parkinson’s disease and other movement disorders, as well as obsessive compulsive disorder.  In order to receive approval, the device had to pass certain parameters as established by the FDA.

Medtronic conducted a study using the brain stimulator on one hundred and ten patients who had not responded to drug therapy.  Half of the patients received power to the devices and none of them knew whether they had an active or inactive device.  Over a three month period, those with the active devices reported a reduction in seizures of approximately 2.3 a month compared to the inactive group.  In the last month of treatment, active users reported a reduction of 6.5 seizures a month.  Although the stimulator appeared to have some effect at decreasing the amount of seizures, the FDA noted that the numbers were not statistically significant.  The Wall Street Journal reports that the FDA neurological device panel will review all of the findings on March 12, 2010 (TODAY) to see if it could be used for epilepsy sufferers.

It appears that the device may take some time for individuals to realize a significant improvement, but Medtronic contends that after two years of use, most users report a reduction in seizures by almost fifty-six percent.  Most of the people who were studied using the device had severe forms of epilepsy and had not responded to numerous rounds of drug treatment.  Having a device such as Medtronic’s would provide a good deal of relief to people living with epilepsy.  Because seizures are unpredictable, having a device help regulate their frequency would allow people to better manage their lives, including working.  It will be important for Medtronic to report on how the device may impact other conditions, such as depression and anxiety in patients, as well as if it would worsen seizure frequency in individuals who do not have a severe form of epilepsy.  There are still many questions that need to be answered, and despite statistical issues, it seems that Medtronic will eventually be able to introduce this device to the seizure disorder market. We will continue to follow this device closely ad let you know what results from today’s panel on the matter.

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  1. [...] week we discussed Medtronic’s new brain stimulation device for the treatment of epilepsy and how it was going before an advisory panel for the Food and Drug Administration. The panel [...]

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