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News Release

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 neurostimulator.

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 accessing.

"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 and www.tamethepain.co.uk.

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.