2013-01-28 14:02:46 -
First Patients Treated in Global Clinical Trial Evaluating Impact of Therapy on
Predominant Low Back Pain
MINNEAPOLIS - January 28, 2013 - Medtronic, Inc. (NYSE: MDT) today announced the
start of PROMISE, a Prospective, Randomized Study of Multicolumn Implantable
Lead Stimulation for Predominant Low Back Pain. This is the first-ever, large-
scale study comparing the effectiveness of Medtronic neurostimulation therapy
with Specify(®) 5-6-5 multicolumn surgical leads plus optimal medical management
(OMM) to the administration of OMM alone in patients with failed back surgery
syndrome (FBSS) and predominant low back pain.
"Chronic pain is a clinically challenging and often debilitating condition for
which oral medications may provide insufficient relief," said Bart Edmiston,
M.D., principal investigator for the PROMISE study at The Neuroscience Center in
Ocean Springs, Mississippi, which enrolled the study's first patient on January
8. "The PROMISE study will add to the growing body of evidence supporting
Medtronic neurostimulation therapy, a well-established therapeutic approach, for
the patients worldwide who continue to experience low back pain following back
surgery."
It is estimated that more than 100 million U.S. adults1 and one in five European
adults2 live with chronic pain. Back pain is the most prevalent type of chronic
pain, affecting approximately 10 percent of the U.S. population alone.3 FBSS is
defined as persistent or recurring pain in the back or legs following one or
more spine surgeries. The majority of FBSS patients receive physical
rehabilitation and/or oral medications to help manage their pain, but studies
and clinical experience find that many of these patients will not sufficiently
improve and will require additional interventions.4
Medtronic neurostimulation therapy (also known as spinal cord stimulation, or
SCS) is a widely established treatment option for chronic back and/or leg pain
that has been used to treat more than 250,000 people worldwide. It uses a
medical device to deliver mild electrical impulses to the spinal cord to block
pain signals from reaching the brain.
PROMISE is a prospective, randomized, open-label, parallel-group, clinical study
enrolling up to 300 individuals suffering from predominant chronic low back pain
due to FBSS at 30 centers in the United States , Canada and Europe (Belgium,
France, Germany, Spain, The Netherlands and The United Kingdom). It is the first
large-scale, randomized, controlled clinical trial designed to assess the value
of SCS for predominant low back pain with leg pain using a surgical lead, in
contrast to previous studies of this technology, which have focused on
predominant leg pain.
"Spinal cord stimulation has become an increasingly valued treatment approach in
chronic pain, and we look forward to participating in the latest study," said
Philippe Rigoard, M.D., the study's global principal investigator, who started
enrolling patients January 14 at Poitiers University Hospital in Poitiers,
France. "If the PROMISE results are positive, they will provide critically
needed relief for those patients suffering from chronic low back pain associated
with FBSS."
PROMISE participants will be randomized 1:1 to receive treatment with either SCS
with OMM or OMM only. After a six-month observational phase, the study will
compare the proportion of participants in the SCS group who report more than 50
percent reduction in low back-pain intensity, as measured by the Numeric Pain
Rating Scale, with those in the OMM-only group. Health care utilization data
collected will be used to develop cost analysis models for potential use in
future studies evaluating the long-term economic impact of SCS.
"Medtronic is committed to advancing the understanding of its neurostimulation
therapy in patients with low back pain resulting from FBSS," said Julie Foster,
general manager and vice president, Pain Stimulation and Targeted Drug Delivery
in the Neuromodulation business of Medtronic, Inc. "PROMISE provides the
opportunity to assess not only the degree of pain relief provided by SCS plus
OMM compared to OMM alone in failed back surgery patients, but also to evaluate
the economic and quality of life impact of this treatment by looking at such
important measures as sleep, ability to work and changes in pain medication."
More information about the PROMISE study, including enrollment information, can
be obtained at
clinicaltrials.gov/ct2/show/NCT01697358?term=medtronic+and+back+ ..
=1.
Medtronic's Leadership in Neuromodulation
Medtronic developed and leads the field of neuromodulation, the targeted and
regulated delivery of electrical pulses and pharmaceuticals to specific sites in
the nervous system. The company's Neuromodulation business includes implantable
neurostimulation and targeted drug delivery systems for the management of
chronic pain, common movement disorders, spasticity and urologic and
gastrointestinal disorders.
About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global
leader in medical technology - alleviating pain, restoring health and extending
life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as
those described in Medtronic's periodic reports on file with the Securities and
Exchange Commission. Actual results may differ materially from anticipated
results.
- end -
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1 Relieving Pain in America: A Blueprint for Transforming Prevention, Care,
Education, and Research; Consensus Report, Institute of Medicine (IOM), June
2011. Page 1.
2Breivik H, Collett B, Ventafridda V, Cohen R, Gallagher D. Survey of chronic
pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain
2006;10:287-333.
3Hardt J, Jacobsen C, Goldberg J, Nickel R, Buchwald D.: Prevalence of chronic
pain in a representative sample in the United States. Pain Medicine
2008; 9:7: 0nstitute of Medicine (IOM), s are estimated tople in the United
States. sequent implants depending on levell ulation to area803-812.
4Chan C, Peng P. Review Article: Failed Back Surgery Syndrome. Pain Medicine
2011; 12: 577-606.
Contacts:
Donna Marquard
Public Relations
+1-763-526-6248
Jeff Warren
Investor Relations
+1-763-505-2696
Jon Pike
Public Relations
+44 7825 889 607
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Source: Medtronic, Inc. via Thomson Reuters ONE
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