In a move that the US Food and Drug Administration (FDA) turned down earlier this year based on a lack of evidence that it actually works, St. Jude Medical has won European CE regulatory approval for the use of its implanted neurostimulation device for patients with severe chronic migraine headaches. Earlier this summer, the FDA said it wanted to see an even greater rate of migraine improvement for patients in the study using the device compared with those in a control group.

The new European device treats migraines by stimulating nerves at the base of the head with electrical pulses, which seems to block pain signals from reaching the brain, St. Jude said. There are currently few treatments for people who suffer serious recurring migraine headaches.

The therapy for this condition involves delivering mild electrical pulses to the occipital nerves that are located just beneath the skin at the back of the head. A small electrical lead or leads are placed under the skin and are connected to the neurostimulator, which produces the stimulation.

Back in June of this year St. Jude, based in Little Canada, said that a study of 157 patients with serious recurring migraine headaches found that, among those treated, there was about a 27% decrease in headaches. However, patients in the study didn’t meet the FDA’s requirement of a 50% reduction in pain from migraines.

Patients in the study were asked to define their headache relief as excellent, good, fair, uncertain, or poor. At the 12 week end point however, 53% of patients in the active group ranked their relief as excellent or good compared to 17% in the placebo group. The FDA still wanted more evidence of success so US approval is still on hold.

Stephen D. Silberstein, M.D., past president of the American Headache Society, director of the Jefferson Headache Center comments:

“Many migraine patients have exhausted all current treatment options and often are disabled by the pain and frequency of migraine attacks. Achieving a reduction in the number of days they suffer from headache and a significant improvement in their quality of life may be even more important than pain reduction alone. This research demonstrates that peripheral nerve stimulation can ease the suffering of chronic migraine patients.”

According to the World Health Organization (WHO), 10% of adults worldwide suffer from migraine, a disabling condition that can last for hours or days at a time. WHO also estimates 1.7 to 4% of adults have headaches on more than 15 days per month. In the US alone, it is estimated that almost 28 million Americans suffer from migraine, or roughly 13% of the population, according to the National Headache Foundation. The severity of each migraine attack can vary widely, with typical symptoms ranging from sensitivity to light, noise and motion, to nausea and vomiting in addition to headache.

This type of migraine the device is approved for 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.

Chris Chavez, president of the St. Jude Medical Neuromodulation Division added:

“This CE Mark is the first approval by a regulatory body for the use of neurostimulation to manage the debilitating symptoms of intractable chronic migraine and provides a new option for patients who have generally exhausted all other treatment options. For more than six years we have worked with our investigators to develop and evaluate this life-changing therapy. We will continue to work with regulatory authorities to secure approvals in order to offer this therapy option to patients throughout the world.”

Written by Sy Kraft