St Jude Medical has announced it has received the CE mark approval for its Eon family of neurostimulators for patients with intractable chronic migraine. The approval includes the Eon Mini neurostimulator, which, according to St Jude, is the world’s smallest rechargeable neurostimulator with the longest-lasting battery in its class, and the Eon and EonC neurostimulators.
Preceding the Eon family approvals, the company received the CE mark for its Genesis neurostimulation system, the industry’s first regulatory approval for an implanted neurostimulation device to treat patients with intractable chronic migraine.
“Intractable chronic migraine is one of the most difficult-to-treat headache disorders,” said Gennaro Bussone, head of the Neurological Department at Istituto Besta in Milan, Italy. “By definition, people living with this condition 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.”
The Eon and Genesis systems deliver peripheral nerve stimulation (PNS) of the occipital nerves to manage the pain and disability associated with intractable chronic migraine. PNS therapy for this condition involves the delivery of mild electrical pulses to the occipital nerves. A small electrical lead or leads are placed under the skin and connected to the neurostimulator, which produces the pulses of stimulation.
Prior to receiving these approvals, St Jude Medical conducted a large scale double-blind, randomised, controlled clinical study evaluating PNS to treat the pain and disability associated with chronic migraine. After 12 weeks of stimulation, patients reported an average of six fewer headache days a month. After one year of stimulation, 65% of patients reported excellent or good pain relief and 89% said they would recommend the procedure to someone else. Study data were presented at the International Headache Congress in 2011 and have been accepted for publication.