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Pain-relief implant puts more power in hands of patients
First of its kind in Europe, Medtronic’s new implantable RESTORE™ rechargeable neurostimulator gives people with drug-resistant neuropathic pain a better quality of life
ROME - 13 June 2005 - Thousands of Europeans affected by the most complex and
severe chronic pain syndromes could benefit from a proven treatment option that
uses a new implantable medical device from Medtronic called the RESTORE™ rechargeable
The first of its kind in Europe, the new device provides neurostimulation therapy,
which delivers pulses of mild electrical current to the spinal cord or peripheral
nerves to relieve neuropathic pain when medication fails to provide adequate
relief or causes intolerable side-effects.
Neuropathic pain, which involves the nerves, commonly affects a combination
of the lower back and one or both legs. A type of chronic pain, it may or may
not follow back surgery. With an estimated 17 million sufferers in Europe, neuropathic
pain often proves difficult to treat with medication alone. In fact, pain specialists
point out that only half of all neuropathic pain patients respond favourably
to medication. Neurostimulation therapy represents a viable treatment option
for drug-restistant neuropathic pain patients.
About the size of a stopwatch, the neurostimulator is implanted under the skin
of the abdomen and connected to one or two insulated wires, called leads, which
carry the therapeutic electrical pulses directly to the target site. Each lead
holds eight evenly spaced electrodes. Based on individual patient needs, the
leads can be positioned and the electrodes programmed to tailor the stimulation,
which blocks pain signals from reaching the brain.
Introduced to pain specialists attending the International Neuromodulation
Society congress at Rome's Catholic University and launched simultaneously across
Europe, the RESTORE neurostimulator contains the most powerful and longest-lasting
rechargeable battery available in the world. Indicated to manage chronic, complex
pain in the trunk and/or limbs, the new device forms part of a comprehensive
system that gives patients the power to tailor their own therapy.
Pioneered by Medtronic, neurostimulation therapy reduces pain and improves
quality of life without causing nausea, vomiting, dizziness or sedation - common
side-effects of routinely prescribed pain medication. According to clinical
studies, neurostimulation provides 65 per cent of patients with 50 per cent
long-term pain relief, which represents a significant clinical accomplishment
in patients who are refractory to medical therapy. Yet despite these results,
neurostimulation remains an underused therapy that many patients have difficulty
"The RESTORE neurostimulator will make this powerful therapy accessible
to more patients", according to anaesthetist Dr Jean-Pierre Van Buyten,
head of the Pain Clinic at AZ Maria Middelares Kliniek in Sint-Niklaas, Belgium,
and the first clinician in Europe to implant the new device. "It can be
programmed easily to meet each patient's individual needs. In fact, patients
implanted with the RESTORE neurostimulator can tailor their own therapy with
a hand-held programmer that adjusts the various stimulation settings within
parameters set by their physician".
"Because of the device's sophistication and its battery's longevity",
Dr Van Buyten continued, "patients have more autonomy, a feeling of empowerment.
They require fewer visits to hospital for reprogramming and replacement, and
that will save the healthcare system money and other resources over the long-term".
The new device's rechargeable battery lasts for nine years, exceeding the longevity
of any other rechargeable neurostimulator in the world - and like a mobile phone
battery, it can be recharged. When battery levels are low, an alarm sounds and
an icon appears on the patient's remote control, indicating the need to recharge.
Recharging can occur without interrupting stimulation.
The device's high-power battery offers patients the convenience and flexibility
of the longest time between recharge periods. Patients will typically need to
recharge the battery approximately once per month, whereas other devices on
the market may require recharges as frequently as once per week.
"The RESTORE neurostimulator is the most sophisticated device of its kind
on the market today", said Martha Aronson, vice president of Medtronic's
Neurological business in Western Europe. "It represents the latest addition
to the Medtronic portfolio of neurostimulation and infusion therapies for the
treatment of chronic pain. Medtronic now provides the broadest range of therapeutic
devices for chronic pain management to best address patient needs".
Defined as pain that persists or recurs for more than six months, chronic pain
strikes one in five adults across Europe. It results from a variety of injuries
and diseases, and most commonly affects the lower back and legs. Left untreated
or under-treated, chronic pain can lead to disability, unemployment, family
problems, low self-esteem, depression, anxiety, reclusion and suicide. Beyond
the personal consequences, chronic pain places a significant burden on families,
communities and society at large. It results in an estimated 300 million lost
working days in Europe each year.
Since being introduced by Medtronic in the 1970s, neurostimulation therapy
has achieved worldwide medical acceptance for the management of chronic, intractable,
unilateral or bilateral pain associated with many pain-related conditions. More
information on neurostimulation can be found online at www.medtronicpaintherapies.com
Founded in 1949, Medtronic is the world's leading medical technology company,
providing lifelong solutions for people with chronic disease. UK operations,
based in Watford since 1987, began in 1972. More information about the company
can be found online at www.medtronic.co.uk
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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
30 April 2004. Actual results may differ materially from anticipated results.