EU Approval for Neurostimulator in Chronic Migraine

Emma Hitt, PhD


September 25, 2012

September 25, 2012 — A neurostimulator system (Eon Mini, St. Jude Medical Inc) has received European Union (EU) CE Certification for the treatment of intractable chronic migraine.

The device delivers peripheral nerve stimulation (PNS) to relieve intractable chronic migraine, defined as headache lasting at least 4 hours per day for 15 or more days per month, causing at least moderate disability, and not responding to 3 or more preventive drugs.

The approval was based on the findings of a randomized trial evaluating PNS to treat the pain and disability associated with chronic migraine. After 12 weeks of treatment, patients reported an average of 6 fewer headache days a month. At 1 year, about two thirds of patients reported their pain relief as "excellent" or "good." In addition, 89% said they would recommend the procedure to someone else.

According to the manufacturer, the device is approximately the size of a large watch, and its "small size allows for a smaller incision, which gives physicians increased flexibility in selecting the implant location and is intended to make the site less visible and more comfortable for patients."

The device, which uses a rechargeable battery, is designed to deliver stimulation over a long period, which helps in the treatment of patients who require extended periods of stimulation throughout the day.

These neurostimulators are the "only fully implantable neurostimulation devices approved in Europe for the management of the pain and disability associated with intractable chronic migraine," a manufacturer release states. "They are also approved in many countries for the management of chronic pain of the trunk and limbs."