Implantable Neurostimulation Device for Chronic Migraine Receives CE Mark

by SHIV GAGLANI on Sep 8, 2011 • 1:01 pm

Remember that headache you got the day after the New Year’s Eve party from drinking too much champagne? Or the one after that big argument with your significant other? Now imagine it lasting for four hours each day, 26 days in a row.

That is, on average, the headache duration of patients who enrolled in St. Jude Medical‘s randomized, double-blind, controlled clinical trial to determine the efficacy of its implanted neurostimulation device, the Genesis, in treating intractable chronic migraines (defined as “headache lasting at least four hours per day for 15 or more days per month, causing at least moderate disability, and not responding to three or more preventive drugs.”). The positive results of that study, discussed in the company’s press release below, led to the device receiving European regulatory approval (CE Mark) earlier this month.

The device works through peripheral nerve stimulation (PNS) of the occipital nerves located just below the skin in the back of the head. Implanted electrical leads generate small pulses that apparently reduce migraine symptoms.

According to the press release:

The largest clinical study to date evaluating PNS to treat chronic migraine utilized various measures including the Migraine Disability Assessment (MIDAS) questionnaire, subjective assessment scales and daily patient diaries to report headache intensity, frequency, duration and medication use. At 12 weeks, patients in the active group reported an average of seven fewer headache days a month as measured by the MIDAS questionnaire compared to only a one day per month decrease in the control group (non-stimulation group). In addition, overall disability as measured by MIDAS demonstrated that participants in the active group showed a 41% improvement after 12 weeks of stimulation, compared to a 13% improvement in the control group.

Results at one year included:

65 percent of patients reported excellent or good pain relief
88 percent said they would recommend the procedure to someone else
68 percent of patients expressed that their quality of life had improved
67 percent were satisfied or very satisfied with the results of their procedure

http://medgadget.com/2011/09/implantable-neurostimulation-device-for-chronic-migraine-receives-ce-mark.html