St. Jude Medical’s Eon family of neurostimulators receives European CE Mark approval

St. Jude Medical, Inc.Sep 21 2012

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced it has received European CE Mark approval of its Eon^™ family of neurostimulators for patients with intractable chronic migraine. Unveiled at the European Headache and Migraine Trust International Congress in London, this approval includes the Eon Mini^™ neurostimulator, which 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 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."

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. This type of migraine is 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. PNS therapy for this condition involves the delivery of mild electrical pulses to the occipital nerves that are located just beneath the skin in the back of the head. 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, randomized, 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 percent of patients reported excellent or good pain relief and 89 percent 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.

"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."