CE Mark approval for St Jude neurostimulator

ST. PAUL, Minn -- St. Jude Medical, Inc has received the European CE Mark approval of its Eon? family of neurostimulators for patients with intractable chronic migraine. The CE Mark approval includes the Eon Mini neurostimulator, the world’s smallest rechargeable neurostimulator with the longest-lasting battery in its class, and the Eon and EonC neurostimulators.

The Eon devices were unveiled at the European Headache and Migraine Trust International Congress in London. Prior to the Eon family approval, St. Jude Medical also received the European 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 Professor Gennaro Bussone, M.D., 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.”

Intractable chronic migraine is defined as headache lasting at least four hours per day for 15 or more days per month. This type of migraine causes at least moderate disability, and does not respond to three or more preventive drugs.

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. A small electrical lead or leads are placed under the skin and connected to the neurostimulator, which produces the pulses of stimulation.

St. Jude Medical conducted a large scale double-blind, randomised, controlled clinical study evaluating PNS to treat chronic migraine. After 12 weeks of stimulation, patients reported an average of six fewer headache days a month. After one year of stimulation, 65 percent of patients reported excellent or good pain relief and 89 percent said they would recommend the procedure to someone else. The study was presented at the International Headache Congress in 2011 and has been accepted for publication.

“Neurostimulation technology represents an exciting new approach to treat intractable chronic migraine,” said Eric S. Fain, M.D., president of the St. Jude Medical Implantable Electronic Systems Division. “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.”