The European Union has granted CE mark approval to a mini rechargeable neurostimulator, developed by St Jude Medical to relieve pain and disability associated with intractable chronic migraine.
Eon Mini, which the neuromodulation technology developer claims is the world’s smallest rechargeable neurostimulator, uses electrical leads to deliver mild electrical pulses, and stimulates occipital nerves located just beneath the skin in the back of the head.
The approval was accorded based on positive clinical results from a double-blind, randomised, controlled clinical study, designed to demonstrate the ability of the device to treat chronic migraines in patients 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, Milan, neurological department head professor Dr Gennaro Bussone said people with chronic migraines 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 said.
In addition to Eon Mini neurostimulator approval, the company has been awarded the CE mark for its Eon and EonC neurostimulators, as well as its implantable Genesis neurostimulation system.
Eon neurostimulator, which the company believes is useful for patients who need the system for a large percentage of the day, features a rechargeable battery to provide stimulation over a long period of time, while EonC neurostimulator is useful for patients who prefer the simplicity of a non-rechargeable medical device.
St Jude Medical implantable electronic systems division president Dr Eric Fain said; "We are proud to be able to offer this potentially life-changing therapy for patients who suffer with this debilitating condition and so desperately need a more effective treatment option."
Image: The new mini rechargeable neurostimulator delivers mild electrical pulses to the occipital nerves for reliveing chronic migraine headaches.Photo: Business Wire