Medtronic Initiates U.S. Trial to Evaluate the Use of Subcutaneous Peripheral Nerve Stimulation for Chronic Back Pain

Thu Apr 11, 2013 9:30am EDT

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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 Mayfield Clinic.

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(R) 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 http://clinicaltrials.gov/ct2/results?term=subqstim
http://clinicaltrials.gov/ct2/results?term=subqstim . Patient information on approved Medtronic
neurostimulation pain therapies is available at www.tamethepain.com http://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 #_edn1  Back pain is the
most prevalent type of chronic pain, affecting approximately 10 percent of the U.S. population.2
#_edn2 Many 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 #_edn3 

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 http://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.


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1 #_ednref1  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: http://www.nap.edu/openbook.php?record_id=13172&page=1
http://www.nap.edu/openbook.php?record_id=13172&page=1 .



2 #_ednref2 Hardt 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.



3 #_ednref3 Chan 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


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