St Jude Medical has obtained CE mark for its new Eon Mini neurostimulator, designed for relieving pain and disability associated with intractable chronic migraine.
By using electrical leads, the small rechargeable neurostimulator delivers mild electrical pulses and stimulates occipital nerves which are located just beneath the skin in the back of the head.
The approval was based on positive clinical results from a double-blind, randomized, controlled clinical study, designed for evaluating the ability of the device in treating chronic migraine pain in patients who are not responding to three or more preventive drugs.
Patients studied after 12 weeks of stimulation reported an average of six fewer headache days a month, while 65% of patients studied after one year reported excellent or good pain relief.
Istituto Besta neurological department head professor Gennaro Bussone said people living with chronic migraine pain are spending half their month living with debilitating headaches.
"This therapy expands our options in helping manage patients who suffer with disabling chronic migraine symptoms," Bussone added.
In addition to Eon Mini neurostimulator approval, the company has obtained CE mark for its Eon and EonC neurostimulators as well as implantable Genesis neurostimulation system.