Canadian-led study finds that neurostimulation therapy significantly reduces chronic leg and back pain



    Largest ever controlled study shows Medtronic neurostimulation therapy
    provides more relief than medication alone

    MISSISSAUGA, ON, Oct. 15 /CNW/ - A major Canadian-led study recently
published by the international medical journal PAIN and supported by Medtronic
Inc. offers hope to millions of chronic pain patients around the world. The
study found that people with debilitating neuropathic leg and back pain
benefit significantly more from neurostimulation therapy than from
conventional medical management alone.
    Neurostimulation therapy, developed in the 1970s, uses an implantable
medical device to deliver electrical pulses which block pain signals in the
spinal cord. In the study, conventional medical management included oral
medications, nerve blocks, steroids, physiotherapy, psychotherapy and
chiropractic care.
    The study, known as PROCESS (for PROspective randomized Controlled trial
of the Effectiveness of Spinal cord Stimulation), showed that neurostimulation
therapy plus conventional medical management provided patients with
significantly greater pain relief, quality of life, functional capacity and
treatment satisfaction than conventional medical management alone after six
months. In addition, 48 per cent of the patients assigned to receive
neurostimulation plus conventional treatments experienced a 50 per cent or
greater improvement in leg pain compared to nine per cent of patients assigned
to receive only conventional treatments (p(less than)0.001).
    "Patients with persistently disabling neuropathic pain in the back and
legs represent one of the most difficult treatment problems in clinical
practice, the real-world setting of our trial," said the study's principal
investigator, Krishna Kumar, M.D., clinical professor, University of
Saskatchewan and president of the Canadian Neuromodulation Society. "Our
findings show that neurostimulation offers patients in this situation a
treatment option that can relieve their pain to a significantly greater degree
than conventional medical management alone - and, as a result, helps to
restore quality of life and functional capacity as well. Neurostimulation
therapy should therefore be added to the list of conventional treatments and
routinely considered for appropriate patients."

    About the PROCESS Trial

    PROCESS is the largest multi-centre randomized controlled trial of
neurostimulation therapy ever conducted. The study design randomly assigned
100 patients, which were enrolled, from 12 academic medical centres in
Australia, Belgium, Canada, Israel, Italy, Spain, Switzerland, and the United
Kingdom to receive conventional medical management (CMM) or neurostimulation
therapy for a period of six months and includes long-term follow-up up to 24
months. Patients assigned to receive neurostimulation were allowed to receive
conventional medical therapies as needed. These included oral medications,
nerve blocks, steroid injections, physical and psychological therapy, and/or
chiropractic care.
    The study's primary end point was the proportion of patients in each
group reporting an improvement of leg pain relief of at least 50 per cent
after six months. Secondary outcomes included improvement in leg and back
pain, health-related quality of life, patient satisfaction with treatment,
functional capacity, change in use of pain therapies (pharmacological and
non-pharmacological), and the frequency and nature of adverse events.
    All 100 patients in the study had undergone at least one anatomically
successful spine surgery for a herniated disk but continued to experience
moderate to severe pain in one or both legs, and to a lesser degree in the
back, for at least six months. They were not considered candidates for
additional spine surgery. Their pain resulted from nerve damage due to an
untreated or long-standing spinal nerve root compression, by disc protrusion
or following spine surgery involving a decompression laminectomy, foraminotomy
or spine fusion. Due to neuropathic pain at the time of enrollment patients
had significantly diminished quality of life comparable to those with
congestive heart failure or terminal cancer.
    The study reports some adverse events after 12 months of treatment. The
main complications among patients who received neurostimulation therapy
included electrode migration, infection, and loss of paresthesia. Twenty-four
per cent of patients in this group experienced an event that required surgery
to resolve. In addition, some patients in each group experienced non-device
related events, including an adverse reaction to a drug or the development of
a new illness, injury or condition.

    About Neuropathic Pain

    Neuropathic pain, caused by various central and peripheral nerve
disorders, is especially problematic because of its severity, chronicity and
resistance to simple analgesics. The condition affects two per cent to eight
per cent of the population - over one million Canadians. Neuropathic pain most
commonly afflicting the back and legs is costly to the healthcare system and
is personally devastating to the people who experience it.
    "Medtronic offers a range of effective treatment options for people with
chronic pain, from minimally invasive spine surgery to neurostimulation and
intrathecal drug therapy," said Mr. Neil D. Fraser, President of Medtronic of
Canada Ltd. "Our company remains committed to making significant investments
in clinical research and product development for the benefit of people with
chronic pain and their physicians."

    About the Neuromodulation Business at Medtronic

    Medtronic developed and leads the field of neuromodulation, which is a
targeted and regulated delivery of electrical pulses, pharmaceuticals, and
biologics to specific sites in the nervous system. The company's
Neuromodulation business offers innovative therapies for chronic pain,
movement disorders, spasticity, overactive bladder and urinary retention,
benign prostatic hyperplasia, and gastroparesis.

    About Medtronic

    Medtronic is the world leader in medical technology providing lifelong
solutions for people with chronic disease. We offer products, therapies and
services that enhance or extend the lives of millions of people. Each year,
five million patients benefit from Medtronic's technology, used to treat
conditions such as diabetes, heart disease, neurological, spinal, and ENT
disorders, and vascular illnesses.
    The Canadian Headquarters for Medtronic of Canada have been in
Mississauga, ON since 1972. We house a museum, an educational centre, sales,
service, and distribution facilities for all Medtronic products licensed for
sale in Canada. We employ over 350 Canadians across Canada and have 2 regional
offices in Vancouver and Montreal.

    Any forward-looking statements are subject to risks and uncertainties
such as those described in Medtronic's Annual Report on Form 10-K for the year
ended April 28, 2006. Actual results may differ materially from anticipated
results.





For further information:

For further information: Vesna Krklinski, Six Degrees Medical
Consulting, (416) 643-8621, vkrklinski@sixdegreesmed.com

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Medtronic of Canada Ltd.

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