* Wins CE Mark approval for neurostimulation device
* FDA wanted to see greater improvement
* Company pegs market over $1 billion
CHICAGO, Sept 7 St. Jude Medical Inc (STJ.N) said it had won European regulatory approval for the use of its implanted neurostimulation device for patients with severe chronic migraine headaches.
The maker of heart valves, pacemakers and other medical devices said on Wednesday that it had received European CE Mark approval for its Genesis neurostimulation system.
The system works by stimulating the occipital peripheral nerves for the management of 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.
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.
It is not clear when the device will win approval in the United States. Earlier this summer, the U.S. Food and Drug Administration 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 company has said it believes the market for the device could exceed $1 billion. (Reporting by Debra Sherman; Editing by Lisa Von Ahn)