* 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)