St Jude gains CE mark for implanted neurostimulation device for
migraine
12 September 2011
St. Jude Medical, Inc. (NYSE:STJ), has received the industry’s
first regulatory approval for the use of an implanted neurostimulation
device for patients with intractable chronic migraine.
The company received European CE Mark approval for its Genesis
neurostimulation system for peripheral nerve stimulation (PNS) of
the occipital 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.
PNS therapy for this condition involves the delivery of 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 connected to the neurostimulator
which produces the pulses of stimulation.

“As a professor and practicing neurologist who works with these
patients on a daily basis, I see firsthand the challenges they face
in trying to manage their pain and disability and how chronic
migraine impacts their lives and their families,” said Dr. Stephen
D. Silberstein, past president, American Headache Society, director
of the Jefferson Headache Center, and the principal investigator in
a recent St. Jude Medical chronic migraine clinical trial. “Through
my participation in this study, I have observed the life-changing
potential this therapy offers chronic migraine patients.”
The CE Mark approval was supported by the results of St. Jude
Medical’s chronic migraine study, a randomized, double-blind,
controlled study that collected data from 157 patients. On average,
participants enrolled in the study suffered from headache 26 days
per month.
The largest clinical study to date evaluating PNS to treat
chronic migraine utilized various measures including the Migraine
Disability Assessment (MIDAS) questionnaire, subjective assessment
scales and daily patient diaries to report headache intensity,
frequency, duration and medication use.
At 12 weeks, patients in the active group reported an average of
seven fewer headache days a month as measured by the MIDAS
questionnaire compared to only a one day per month decrease in the
control group (non-stimulation group). In addition, overall
disability as measured by MIDAS demonstrated that participants in
the active group showed a 41% improvement after 12 weeks of
stimulation, compared to a 13% improvement in the control group.
Results at one year included:
- 65% of patients reported excellent
or good pain relief;
- 88% said they would recommend the procedure to
someone else;
- 68% of patients expressed that their quality of life
had improved;
- 67% were satisfied or very satisfied with the results
of their procedure.
Results of the major study endpoints were presented in abstract
and poster format at the International Headache Congress in Berlin
in June 2011. Study data will be submitted for publication in
medical journals later this year and early 2012.
“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,” said
Chris Chavez, president of the St. Jude Medical Neuromodulation
Division. “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.”
Source: St Jude Medical