Medtronic, Inc. : Medtronic Initiates U.S. Trial to Evaluate the Use of
Subcutaneous Peripheral Nerve Stimulation for Chronic Back Pain
MINNEAPOLIS - April 11, 2013 - Medtronic, Inc. (NYSE: MDT) today announced the
first patient enrollments in the SubQStim II pivotal clinical trial to pursue
U.S. Food and Drug Administration (FDA) approval of peripheral nerve
stimulation (PNS), also known as subcutaneous nerve stimulation (SQS), for the
reduction of chronic, intractable post-surgical back pain.
PNS involves an implant of electrical leads just under the skin of the lower
back. These leads are connected to a stimulator which delivers mild electrical
impulses to the nerves, interrupting pain signals traveling through the
nervous system to the brain. Medtronic received CE (Conformité Européenne)
Mark for the first 16-electrode, fully implantable system for the percutaneous
delivery of PNS in the management of chronic back pain in May 2011. PNS using
a fully implantable system is not currently approved by the U.S. Food and Drug
Administration for use in the United States.
The SubQStim II pivotal study is a randomized, controlled, blinded, parallel
arm, multicenter trial to assess the safety and efficacy of PNS for chronic,
intractable post-surgical back pain. The study will recruit up to 323 people
at 30 U.S. centers who will receive PNS using a Medtronic neurostimulation
system. Subjects will be randomized to a treatment or control group for the
first three months and will continue to participate in open label follow-up
for up to five years.
"The SubQStim II pivotal study will provide new information about subcutaneous
nerve stimulation as a potentially valuable treatment option for U.S. patients
with chronic, intractable back pain who have found insufficient relief with
other treatment options," said the study's coordinating investigator, George
Mandybur, M.D., Associate Professor and Director Stereotactic and Functional
Neurosurgery at the University of Cincinnati and a neurosurgeon with the
The first enrollments were performed by principal investigators Yeshvant
Navalgund, M.D., of DNA Advanced Pain Treatment Center in Greensburg,
Pennsylvania, and D. Joseph Meyer, M.D., Ph.D., of Columbia Interventional
Pain Center in Columbia, Missouri.
"Study findings will provide an unprecedented understanding of how leads
placed in the subcutaneous tissue layer work with neurostimulation devices to
help patients manage their chronic back pain," said Dr. Navalgund.
The SubQStim II pivotal study is the latest in a series of clinical trials
sponsored by Medtronic to generate a comprehensive portfolio of evidence
demonstrating the clinical and economic value of its neurostimulation systems
for the management of chronic pain. Medtronic recently initiated the SubQStim
I post-market study in Europe, Israel, Australia and Canada to evaluate the
effectiveness of PNS plus optimal medical management (OMM) for low back pain,
compared to OMM alone in patients with Failed Back Surgery Syndrome (FBSS). In
January, the company announced the beginning of PROMISE, a Prospective,
Randomized Study of Multicolumn Implantable Lead Stimulation for Predominant
Low Back Pain. PROMISE is the first-ever, large-scale study comparing the
effectiveness of Medtronic neurostimulation therapy with Specify® 5-6-5
multicolumn surgical leads plus OMM, to OMM alone in patients with FBSS and
predominant low back pain.
"Medtronic remains committed to investing in research to demonstrate the
clinical and economic value of our industry-leading neurostimulation
technology and ensure our therapies are available to those who may benefit,"
said Julie Foster, general manager and vice president, Pain Stimulation and
Targeted Drug Delivery in the Neuromodulation business of Medtronic, Inc.
"Chronic back pain affects a significant number of adults in the U.S., and if
the SubQStim II pivotal trial results are positive, we plan to pursue FDA
approval to make this potential treatment option available to patients who may
More information about Medtronic's SubQStim studies, including enrollment
information, can be obtained at
http://clinicaltrials.gov/ct2/results?term=subqstim. Patient information on
approved Medtronic neurostimulation pain therapies is available at
www.tamethepain.com or 1-888-430-PAIN (7426).
About Chronic Back Pain
It is estimated that 100 million U.S. adults live with chronic pain.^1 Back
pain is the most prevalent type of chronic pain, affecting approximately 10
percent of the U.S. population.^2Many patients suffering from chronic pain
following spine surgery receive oral medications and other therapy, but
clinical experience finds many of these patients fail to obtain adequate
relief and will require additional interventions.^3
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.
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
- end -
1Relieving Pain in America: A Blueprint for Transforming Prevention, Care,
Education, and Research; Consensus Report, Institute of Medicine (IOM), June
2011. Page 1. Retrieved Feb. 19, 2013, from:
2Hardt 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.
3Chan C, Peng P. Review Article: Failed Back Surgery Syndrome. Pain Medicine
2011; 12: 577-606.
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Source: Medtronic, Inc. via Thomson Reuters ONE
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