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Jon Pike, Public and Media Relations , +44 (0)7825 889 607

NICE approves Spinal Cord Stimulation for Chronic Neuropathic Pain

LONDON – October, 22 2008 – People living a life of constant pain will now have access to Spinal Cord Stimulation (SCS) following new guidance issued by the National Institute for Health and Clinical Excellence (NICE) on Wednesday 22nd October 2008.1

The new guidance from NICE recommends that Spinal Cord Stimulation should be made available to all patients who continue to experience chronic neuropathic pain for at least 6 months despite trying conventional approaches to pain management. Patients will also be required to have had a successful trial of the therapy before a spinal cord stimulator is implanted.1

The guidance is good news for patients with chronic neuropathic pain conditions like Failed Back Surgery Syndrome (FBSS), where a successful back operation fails to stop their pain, and Complex Regional Pain Syndrome (CRPS), a burning pain in one or more limbs. However, NICE has not recommended SCS for people with ischaemic pain ruling out the treatment for people experiencing chronic pain caused by conditions such as refractory angina.

Spinal Cord Stimulation works by sending electric pulses to electrodes placed near the spinal cord that are connected to a fully implanted neurostimulator battery. These pulses are believed to interrupt the pain messages being sent to the brain. A number of patients report that the feeling of pain is significantly reduced with SCS and is often replaced by a gentle tingling sensation in the area of pain.

There are as many as 2,000 cases of Failed Back Surgery Syndrome (FBSS) in the UK every year and Complex Regional Pain Syndrome (CRPS) is estimated to occur after 1 in every 2,000 accidents.2,3 One in five people suffer from chronic pain,4 which affects people of any age and can lead to sleep disturbance and frequent absence from work.

NICE reviewed the available evidence for the treatment of chronic neuropathic pain as part of their health technology appraisal (HTA). All 403 patients included in the clinical studies assessed by NICE were implanted with Medtronic Neuromodulation Constant-Voltage SCS systems.1

Outcome data from the PROCESS trial submitted to NICE demonstrated that treatment with SCS in combination with Conventional Medical Management (CMM) versus CMM alone lead to significantly more FBSS patients achieving a reduction in pain of 50% or more with 48% of SCS patients versus only 9% of CMM patients achieving this primary endpoint.5

Dr Sam Eldabe from the James Cook University Hospital, Middlesborough commented, "Spinal cord stimulation is an important treatment option for people living with neuropathic pain who face considerable pain on a daily basis and who have already tried numerous pharmacological approaches to pain management without success. These new Guidelines, properly implemented at a local level, will provide access to a therapy which can significantly reduce the pain experienced by many people and lead to a dramatic improvement in their quality of life."

Ian Semmons, Chairman of Action on Pain, commented, “This represents a sensible move by NICE for not only does it provide a valuable asset for people affected by pain it also gives NICE the opportunity to revisit their decision in the future with the potential to extend the usage of spinal cord stimulators to encompass other pain related conditions.”

Geoff Morris, Medtronic Regional Vice-President for UK and Ireland, commented: “This decision from NICE demonstrates that spinal cord stimulation is a cost-effective treatment for people living with chronic neuropathic pain. What is important now is that there are referral pathways in place across the country to ensure that the people who will benefit from spinal cord stimulation are referred to specialists who have the expertise to treat them.”


About Medtronic
Medtronic, Inc. (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. About NICE NICE is an independent organisation responsible for providing national guidance in the UK on the promotion of good health and the prevention and treatment of ill health. NICE produces guidance in three areas of health:
• public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
• health technologies - guidance on the use of new and existing medicines, treatments and procedures within the NHS
• clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

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 25, 2008. Actual results may differ materially from anticipated results.

1. NICE, Technology Appraisal- Pain and Spinal Cord Stimulation, October 2008 (http://www.nice.org.uk/guidance/index.jsp?action=byID&o=11739)
2. Talbot, L. Failed back surgery syndrome. BMJ 2003;327:985-986
3. NHS Direct. Complex Regional Pain Syndrome. August 2008.
4. Breivik, H; Hattori, S; Moulin, Dwight E. Prevalence and impact of chronic pain: a systematic review of epidemiological studies on chronic pain. Presented at the International Association for the Study of Pain (IASP) 11th World Congress on Pain, Sydney, Australia. (2005)
5. Kumar, K et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomised controlled trial in patients with failed back surgery syndrome. Pain. 2007; 132: 179-88

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