St Jude mini neurostimulator to treat chronic migraine gains EU
21 September 2012
St. Jude Medical's Eon family of neurostimulators for patients
with intractable chronic migraine has received approval for marketing in
Preceding the Eon family approvals, the company received European
CE Mark for its Genesis neurostimulation system, the industry’s
first regulatory approval for an implanted neurostimulation device
to treat patients with intractable chronic migraine.
The Eon and Genesis systems deliver peripheral nerve stimulation
(PNS) of the occipital nerves to manage 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.
PNS therapy for this condition involves the delivery of mild
electrical pulses to the occipital nerves that are located just
beneath the skin in the back of the head. A small electrical lead or
leads are placed under the skin and connected to the neurostimulator,
which produces the pulses of stimulation.
“Intractable chronic migraine is one of the most
difficult-to-treat headache disorders,” said Professor Gennaro
Bussone, M.D., head of the Neurological Department at Istituto Besta
in Milan Italy. “By definition, people living with this condition
are spending half their month living with debilitating headaches.
This therapy expands our options in helping manage patients who
suffer with disabling chronic migraine symptoms.”
“Neurostimulation technology represents an exciting new approach
to treat intractable chronic migraine,” said Eric S. Fain, M.D.,
president of the St. Jude Medical Implantable Electronic Systems
Division. “We are proud to be able to offer this potentially
life-changing therapy for patients who suffer with this debilitating
condition and so desperately need a more effective treatment
Migraine is a neurological disorder characterized by a number of
specific symptoms that can last for hours or days at a time. 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. In general, chronic
migraine sufferers have progressed to the level where they have
migraine or migraine-like symptoms on more days than they are
Estimates by the World Health Organization (WHO) indicate that
10%of adults worldwide suffer from migraine and 1.7 to 4% of adults
have headaches 15 or more days per month. In fact, migraine ranks as
one of the top 20 most disabling conditions in the world, according
In terms of monetary cost, it has been estimated that migraine
headache is one of the most expensive neurological disorders.
According to the European Journal of Neurology the total annual cost
attributed to migraine amounts to €111 billion in the EU.
Source: St Jude Medical