2013-04-11 15:36:57 -
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
"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 benefit."
More information about Medtronic's SubQStim studies, including enrollment
information, can be obtained at
. 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
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 -
1 Relieving 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