St. Jude Medical Announces European Regulatory Approval of First Implanted Neurostimulation Device to Treat Chronic Migraine
September 07 2011 - 8:00AM
Business Wire
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced it has received the industry’s first and
only 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.
The St. Jude Medical Genesis(TM)
neurostimulation system is the only fully implantable
neurostimulation system that is approved in Europe for peripheral
nerve stimulation (PNS) of the occipital nerves for the management
of the pain and disability for patients diagnosed with intractable
chronic migraine. PNS for intractable chronic migraine 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 Genesis neurostimulator, a pacemaker-like device, which
produces the pulses of stimulation. Photo provided by St. Jude
Medical, Inc. (Photo: Business Wire)
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 percent of patients reported
excellent or good pain relief
- 88 percent said they would recommend
the procedure to someone else
- 68 percent of patients expressed that
their quality of life had improved
- 67 percent 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.”
About Migraine
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
migraine free. Estimates by the World Health Organization (WHO)
indicate that 10 percent of adults worldwide suffer from migraine,
and 1.7 to 4 percent 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 to WHO. For more information
about PNS for intractable chronic migraine, visit
www.MigraineAnswers.co.uk.
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 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 July 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.
Photos/Multimedia Gallery Available:
http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6848720&lang=en
SJM (NYSE:STJ)
Historical Stock Chart
From May 2024 to Jun 2024
SJM (NYSE:STJ)
Historical Stock Chart
From Jun 2023 to Jun 2024