Neurostimulator for Intractable Chronic Migraine Approved in Europe


St. Jude Medical, Inc. has received approval in Europe for an implanted neurostimulator designed to treat intractable chronic migraine.

St. Jude Medical, Inc. announced today that it had received approval in Europe for an implanted neurostimulator designed to treat intractable chronic migraine, which is defined as headache lasting at least four hours per day for 15 days or more per month, causing at least moderate disability and not responding to three or more preventive drugs.

The company’s Genesis system delivers mild electrical pulses to stimulate the occipital peripheral nerves, which are found just under the skin at the back of the head, to help manage the pain and disability that accompany intractable chronic migraine.

The device’s approval was based on the results of a study involving 157 patients who suffered from headaches on average 26 days per month. At 12 weeks, participants in the active group (who received stimulation from the device) reported an average of seven fewer headache days per month compared with just one day per month in the control (non-stimulation) group. In terms of overall disability, those in the active group showed a 41% improvement after 12 weeks compared with 13% improvement among those in the control group.

According to a Reuters report, it remains to be seen whether the device will be approved for use in the US given that earlier in the summer the FDA indicated that it hoped to see a greater increase in improvement among those using the device compared to those in the control group.


St. Jude Medical Announces European Regulatory Approval of First Implanted Neurostimulation Device to Treat Chronic Migraine [Press Release]

St Jude gets OK in Europe for device for migraines [Reuters]

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