St. Jude Medical Reveals Randomized Clinical Trial Data Demonstrating Benefit of Neuromodulation for Chronic Migraine
June 23 2011 - 2:00AM
Business Wire
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced study results on the safety and efficacy
of peripheral nerve stimulation (PNS) of the occipital nerve for
the management of pain and disability associated with chronic
migraine, a debilitating condition that affects millions worldwide.
Presented at the 15th International Headache Congress in Berlin,
Germany, the study shows statistically significant improvement
across multiple measures including a reduction in the number of
headache days per month and improvement in quality of life. This is
the largest clinical study to date evaluating the use of PNS via an
implanted medical device for the treatment of chronic migraine.
The St. Jude Medical Genesis(TM)
neurostimulator is an investigational device being evaluated in
clinical research studies for chronic migraine headache. The
Genesis system emits mild electrical pulses to generate peripheral
nerve stimulation (PNS) of the occipital nerve in the back of the
head. Photo provided by St. Jude Medical, Inc.
The study followed 157 participants who, on average, suffered
from headache 26 days per month. Study participants were implanted
with the St. Jude Medical Genesis™ neurostimulator and randomly
assigned to an active or control group for 12 weeks. The active
group received stimulation immediately upon implant, while patients
in the control group did not receive stimulation until after the
first 12 weeks. All patients were followed for one year. At one
year, 66 percent of patients reported excellent or good pain
relief.
At 12 weeks, the study demonstrated the following statistically
significant results:
- Patients who received stimulation
reported a 28-percent decrease in their number of headache days
(seven less days a month) compared to the placebo group which
reported a 4-percent decrease (one less day per month).
- Overall disability as measured by the
Migraine Disability Assessment questionnaire (MIDAS) indicated
participants in the active group had a 41-percent improvement
compared to a 13-percent improvement in the placebo group.
- Zung Pain and Disability Index (PAD)
scores improved in the active group by 20 percent compared to an
8-percent improvement in the placebo group.
- In addition to the standardized scales
(MIDAS and PAD), patients were asked to subjectively assess their
pain relief. The active group reported 42-percent pain relief
compared to 17 percent in the placebo group.
- Patients in the study were asked to
define their headache relief as excellent, good, fair, uncertain,
or poor. At the 12-week end point, 53 percent of patients in the
active group ranked their relief as excellent or good compared to
17 percent in the placebo group.
- When asked to rate the effect on their
quality of life, 67 percent of the active group reported
improvement compared to 17 percent in the placebo group.
- The active group reported 51-percent
satisfaction with headache relief compared to 19 percent in the
placebo group.
Statistical significance was demonstrated across most measures.
It was not however observed in the primary endpoint as established
by the U.S. Food and Drug Administration. This was defined as a
significant difference between active and placebo groups who
reported a 50-percent reduction in pain as measured on a visual
analog scale and a minimum 10-percent point difference between
the 95-percent confidence intervals comparing the active and
placebo groups. A statistically significant difference between the
active and placebo groups was observed at the 40-percent reduction
in pain level.
“Many migraine patients have exhausted all current treatment
options and often are disabled by the pain and frequency of
migraine attacks,” said Stephen D. Silberstein, M.D., past
president of the American Headache Society, director of the
Jefferson Headache Center, and the principal investigator in the
study. “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.”
St. Jude Medical has filed for CE Mark approval of the Genesis
neurostimulation system for the management of pain and disability
associated with chronic migraine and expects to begin a limited
launch in Europe later this year. It is not yet clear when this
neuromodulation system will be approved for the treatment of
chronic migraine in the U.S. This system delivers mild electrical
pulses from an implanted device to leads placed under the skin at
the back of the head, stimulating the occipital nerves.
About Migraine
According to the World Health Organization (WHO), 10 percent 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
percent of adults have headaches on more than 15 days per month. In
the U.S. alone, it is estimated that almost 28 million Americans
suffer from migraine – or roughly 13 percent 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.
Three Decades of Leading-Edge Neurostimulation
Technology
For more than 30 years, the St. Jude Medical Neuromodulation
Division has developed new technologies to treat chronic pain and
other neurological disorders. Today more than 75,000 patients in 40
countries have been implanted with St. Jude Medical
neurostimulation systems.
Focused on research, St. Jude Medical is developing new
technologies to address a growing list of neurological disorders.
Additional clinical studies are currently underway for Parkinson’s
disease, essential tremor, major depressive disorder, and other
significant indications.
About St. Jude Medical
St. Jude Medical develops medical technology and services that
focus on putting more control into the hands of those who treat
cardiac, neurological and chronic pain patients worldwide. The
company is dedicated to advancing the practice of medicine by
reducing risk wherever possible and contributing to successful
outcomes for every patient. St. Jude Medical is headquartered in
St. Paul, Minn., and has four major focus areas that include
cardiac rhythm management, atrial fibrillation, cardiovascular and
neuromodulation. For more information, please visit
www.sjm.com.
Forward-Looking Statements
This news release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
that involve risks and uncertainties. Such forward-looking
statements include the expectations, plans and prospects for the
Company, including potential clinical successes, anticipated
regulatory approvals and future product launches, and projected
revenues, margins, earnings and market shares. The statements made
by the Company are based upon management’s current expectations and
are subject to certain risks and uncertainties that could cause
actual results to differ materially from those described in the
forward-looking statements. These risks and uncertainties include
market conditions and other factors beyond the Company’s control
and the risk factors and other cautionary statements described in
the Company’s filings with the SEC, including those described in
the Risk Factors and Cautionary Statements sections of the
Company’s Annual Report on Form 10-K for the fiscal year ended
January 1, 2011 and Quarterly Report on Form 10-Q for the fiscal
quarter ended April 2, 2011. The Company does not intend to update
these statements and undertakes no duty to any person to provide
any such update under any circumstance.
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