Neurostimulation Gets CE Mark Approval for Chronic Migraine

Emma Hitt, PhD

September 07, 2011

September 7, 2011 — An implantable neurostimulation device to treat the pain and disability caused by intractable chronic migraine headaches has been granted a CE Mark of approval for use in Europe.

The Genesis neurostimulation system, developed by St. Jude Medical, in St. Paul, Minnesota, is the first device of its kind to win CE mark approval and it is the first regulatory approval for the device for the treatment of chronic migraines.

The US Food and Drug Administration (FDA) approved the Genesis neurostimulation system in 2001 for spinal cord stimulation in chronic back pain associated with failed back surgeries, as well as chronic limb and trunk pain.

When used for intractable chronic migraines, the system stimulates peripheral nerves to target the occipital nerves. Small electrical leads implanted under the skin deliver mild electrical pulses at the back of the head, leading to fewer migraines per month and improved disability. Intractable migraine is defined as headache lasting 4 or more hours per day for at least 15 days per month, causing at least moderate disability, and not responding to 3 or more preventive drugs.

The CE mark was awarded based on the favorable outcome of a randomized, double-blind, controlled study. Patient questionnaires, subjective assessment scales, and patient diaries were used to evaluate headache intensity, frequency, and duration in 157 patients who experienced migraines an average of 26 days per month.

Patients that received peripheral nerve stimulation by the system reported 7 fewer migraines, as compared with 1 less migraine in the control group.

At 12 weeks, overall disability improved 31% in neurostimulated patients compared with a 13% improvement ?in the control group. At 1 year, 65% of neurostimulated patients rated their pain relief as excellent or good, 67% were satisfied or very satisfied with the outcome, and 68% had improvement in quality of life. In addition, 88% indicated that they would recommend the use of the device to others.

Results of the study were presented at the International Headache Congress in Berlin in June and will be submitted for publication by early 2012.

"Based on the CE Mark approval, we plan to release the Genesis system for intractable chronic migraine in Europe later this year. We will begin discussions with regulatory authorities in other markets, including the US Food and Drug Administration [FDA], later this year to determine next steps," said Denise Landry, Director of the Public Relations Neuromodulation Division, at St. Jude Medical.

The system "has been a utilized as a spinal cord stimulator to manage chronic pain of the trunk and limbs and pain from back surgeries that have failed in countries around the world," she told Medscape Medical News. "The technology of the system has not been altered for its use in peripheral nerve stimulation of the occipital nerve for intractable chronic migraine; it is simply a different application of the technology."

Chris Chavez, president of the St. Jude Medical Neuromodulation Division, stated in a press release that the CE approval "provides a new option for patients who have generally exhausted all other treatment options." He indicated that St. Jude Medical "will continue to work with regulatory authorities to secure approvals in order to offer this therapy option to patients throughout the world."

In June 2011, the FDA requested that the manufacturer demonstrate a higher improvement rate in controlling migraines in neurostimulated patients. St. Jude Medical states they plan to initiate discussions to determine their next steps to obtain approval from regulatory bodies governing other markets, including the FDA, later this year.


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