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First European Patients Enrolled in Largest Ever Randomised Controlled Trial of ITB Therapy(R) in Post-Stroke Patients With Severe Spasticity

March 23, 2010

TOLOCHENAZ, Switzerland, March 23, 2010 /PRNewswire-FirstCall/ –

– Spasticity Affects a Significant Number of Post-Stroke Patients,
[1],[2],[3] and Many are not Adequately Treated by Standard Therapy [4]

Medtronic, Inc. (NYSE: MDT) today announced the enrollment of the first
European patients in the largest randomized controlled trial to date to
investigate the benefits of ITB Therapy(R) (Intrathecal Baclofen) in
post-stroke patients affected by spasticity. The announcement comes as the
World Congress for Neurorehabilitation is taking place in Vienna, Austria.

The SISTERS study (Spasticity In STrokE Randomised Study) is expected to
provide high-quality evidence on the efficacy of ITB Therapy, enabling
healthcare professionals to make treatment decisions for post-stroke patients
with severe spasticity who do not respond sufficiently to oral medication and
physical therapy.

Stroke is a major cause of disability, with 15 million new cases each
year worldwide,[5] and over one million people suffering a stroke in Western
Europe
every year.[6] Of these patients, up to 65 percent will suffer from
spasticity as a result,[3] and for many of them, oral medication and/or
physical therapy combined are not enough to manage spasticity.4 Post-stroke
spasticity patients have reduced function and lower quality of life than
patients without the disability.[7,8]

ITB Therapy is an approved treatment for patients with severe generalized
spasticity associated with multiple sclerosis, cerebral palsy, spinal cord
injury, brain injury, and stroke who do not respond to oral medication. ITB
Therapy treats severe non-focal spasticity through a programmable pump, which
is placed under the skin of the abdomen and connected to a catheter.

Once in place, the pump and catheter deliver anti-spastic medication
directly to the site of action in the cerebrospinal fluid surrounding the
spinal cord, where it may be is most effective.[9] Due to its direct
administration into the spine, ITB Therapy requires a lower dosage of
medication compared to oral treatments, while producing a similar reduction
in spasticity with fewer possible side effects than what is often seen with
higher doses of oral baclofen.[9]

“ITB Therapy has the potential to restore quality of life in patients
whose lives have been completely disrupted by a stroke and the impairing and
debilitating symptoms of spasticity,” commented Professor Leopold Saltuari (LKH Hochzirl, Austria), global lead investigator of the SISTERS study. “With
this study we are aiming to demonstrate that there is a way to manage
spasticity for many of them.”

The SISTERS study is an international trial, conducted in 20 sites in
Europe and the US, including European centres in Austria, Belgium, Germany,
Italy, the Netherlands, Spain, and the United Kingdom. The primary endpoint
is the reduction of spasticity after six months of treatment with ITB Therapy
and physical therapy compared to patients treated with one or more oral
medications and physical therapy. Assessments include a 10-meter timed
walking test, other functionality and independence tests, goal attainment
scale, pain measurement, treatment satisfaction, quality of life, and safety
aspects (adverse events).

In several clinical trials to date, ITB Therapy has been shown to provide
a positive impact on the lives of post-stroke patients by reducing spasticity
and increasing quality of life .[8,10] In other trials, 89 percent of
patients with severe spasticity have seen a reduction spasticity-related
pain.[11] In multiple sclerosis and spinal injury, patients experienced a 92
percent decrease in their spasticity symptoms following ITB Therapy.[12]

ITB Therapy has also been shown to improve mobility, daily functioning
and quality of life, to ease patients’ pain and decrease dependency on
nursing care.[10,13] ITB Therapy has been shown to minimize the economic
burden of spasticity, [13] by helping physicians and caregivers improve
function and comfort in patients. [11]

Some patients may experience ITB therapy drug side effects which are
usually temporary and manageable by adjusting the dose. The most common side
effects include loose muscles, drowsiness, nausea/vomiting, headache and
dizziness. Close attention to physician’s instructions is required since
abrupt cessation of intrathecal baclofen can result in high fever, altered
mental status, returned spasticity, and muscle rigidity, and in rare cases
has been fatal. The implanted infusion system may result in complications
such as infection (including meningitis), overdose or underdose resulting
from programming errors or system component failures and cerebral spinal
fluid leakage resulting in a spinal headache.

To date, ITB Therapy has been widely used to treat spasticity which could
not be sufficiently controlled with oral medications in over 15,000 patients
in Western Europe, including people with cerebral palsy and multiple
sclerosis.[14]

For important safety information, please go to

http://www.medtronic.eu/your-health/stroke/safety-information/index.htm.

In the US, prescribing information is available at
http://professional.medtronic.com/interventions/intrathecal-baclofen-therapy/
indications-safety-and-warnings/index.htm.

(Due to the length of these URLs, it may be necessary to copy and paste
this hyperlink into your Internet browser’s URL address field. Remove the
space if one exists.)

About Medtronic

Medtronic, Inc. (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.

This press release contains forward-looking statements related to results
of Medtronic’s operations, which are subject to risks and uncertainties, such
as competitive factors, difficulties and delays inherent in the development,
manufacturing, marketing and sale of medical products, government regulation
and general economic conditions and other risk and uncertainties described in
Medtronic’s periodic reports on file with the Securities and Exchange
Commission. Actual results may differ materially from anticipated results.
Medtronic does not undertake to update its forward-looking statements. Unless
otherwise noted, all comparisons made in this news release are on an “as
reported basis,” not on a constant currency basis, and references to
quarterly figures increasing or decreasing are in comparison to the third
quarter of fiscal year 2009.

References ———————————

[1] Sommerfeld DK. et al. Spasticity after stroke: its occurrence and
association with motor impairments and activity limitations. Stroke. 2004.
35(1):134-140.

[2] Watkins CL. et al. Prevalence of spasticity post stroke. Clinical
Rehabilitation. 2002. August 16(5):515-22.

[3] Gelber DA. et al. Open-label dose-titration safety and efficacy study
of tizanidine hydrochloride in the treatment of spasticity associated with
chronic stroke. Stroke. 2001. 32(8):1841-1846.

[4] Francisco GE et al. Consensus panel guidelines for the use of
intrathecal baclofen therapy in poststroke spastic hypertonia. Top Stroke
Rehabil. 2006;13(4):74-85.

[5] The World Health Organisation: Atlas of Heart Disease and Stroke
2004. Available from:
http://www.who.int/cardiovascular_diseases/resources/atlas/en/

[6] Truelsen T. et al. Stroke incidence and prevalence in Europe: a
review of available data. Eur J Neurol. 2006. 13(6):581-598.

[7] Welmer AK. et al. Spasticity and its association with functioning and
health-related quality of life 18 months after stroke. Cerebrovasc Dis.
2006;21(4):247-53.

[8] Ivanhoe CB, et al. Intrathecal baclofen management of poststroke
spastic hypertonia: implications for function and quality of life. Arch Phys
Med Rehabil. 2006. 87(11):1509-15.

[9] Penn RD, et al. Intrathecal baclofen for severe spinal spasticity.
New England Journal of Medicine 1989;320:1517-21

[10] Meythaler JM, et al. Intrathecal baclofen for spastic hypertonia
from stroke. Stroke. 2001. 32(9):2099-109

[11] Sampson FC et al. Functional benefits and cost/benefit analysis of
continuous intrathecal baclofen infusion for the management of severe
spasticity. J of Neurosur 2002; 96(6): 1052-1507.

[12] Creedon SD, et al. Intrathecal baclofen for severe spasticity: a
meta-analysis. Int J Rehabil Health 1997; 3(3):171-85.

[13] Bensmail D. et al. Cost-effectiveness modeling of Intrathecal
Baclofen Therapy Versus Other Interventions for Disabling Spasticity.
Neurohabil Neural Repair. 2009. Febr. 1-7

[14] Medtronic data on file

SOURCE Medtronic Inc.


Source: newswire



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