This information is intended for media professionals and investors
+61 2 8876 6162
New pain pacemaker restores hope for sufferers
Device with most powerful, longest lasting, rechargeable battery now available to help patients with difficult-to-treat chronic pain
BRISBANE – July 18 2006 – The first rechargeable implanted neurostimulation system for the treatment of chronic pain is now available in Australia following registration by the Therapeutic Goods Administration (TGA).
The Restore neurostimulation system is a new treatment option for people suffering from complex, difficult-to-treat chronic pain. The battery, which like a mobile phone battery is rechargeable, lasts up to nine years, reducing the number of surgeries required to replace expired devices, and therefore the risks and costs associated with these surgeries.
The launch of Restore marks a significant step forward in the treatment of Australians with chronic pain, according to Dr Jim O’Callaghan, Pain Specialist, from Greenslopes Private Hospital in Brisbane, who was the first doctor in Australia to use the system.
“It’s exciting technology. It’s giving the patient greater freedom and less surgical intervention. To have something that is going to go for nine years is very exciting,” said Dr O’Callaghan.
“Restore should help us treat some of the most complex forms of chronic pain better than we have in the past.
“This is welcome news for patients who haven’t had much success with other chronic pain treatments,” he said.
“With this device, the patient controls the pain – the pain doesn’t control the patient."
Chronic pain, defined as pain which lasts more than three months, can have a major impact on a sufferer’s quality of life, preventing people from doing basic everyday activities such as working, shopping or household chores.
The most widespread chronic pain conditions - like low back pain, arthritis and recurrent headache (including migraine) - are so common that they're often seen as a normal and unavoidable part of life.
Although comprehensive epidemiological data for Australasia is not available, chronic pain is known to be a very common condition. It is estimated that chronic pain affects up to 4 million people in Australia and New Zealand.
Many sufferers believe that nothing can be done to help them. Others spend many years trialling a range of treatments in an effort to find relief.
Implantable neurostimulators treat chronic pain by sending carefully controlled electrical pulses (which are felt as tingling sensations) to the spinal cord. They are delivered via a special medical wire, surgically implanted along an incision near the spinal column. The electrical pulses block the pain signals so that they can’t be received by the brain.
The medical wires are connected to a small system, often referred to as a ‘pain pacemaker’ that is surgically placed under the skin, usually in the abdominal area. This neurostimulator, or ‘pain pacemaker’ houses the battery that generates the electrical impulses.
Typically, the battery in an implanted neurostimulation system will last for between three and five years, depending on how much it is used. When the battery expires, surgery is required to remove the neurostimulator and replace it with a new one. Because the Restore battery is rechargeable, it lasts up to nine years, meaning that many chronic pain patients will need fewer procedures to replace the device.
When battery levels are low, an alarm sounds and an icon appears on the system’s programmer screen, alerting patients of the need to recharge. Recharging can occur without interrupting delivery of the stimulation. Patients will typically need to recharge the Restore battery approximately once per month.
Another feature of the Restore system is the hand-held programmer that is similar to a remote control. Patients use it to manually choose from a number of program options – as set by their doctor – to meet his or her individual treatment needs.
Restore is indicated to manage chronic, difficult-to-treat pain in the trunk and/or multiple limbs that is associated with failed back syndrome, post laminectomy pain, unsuccessful disc surgery or degenerative disc disease, among others.
Neurostimulation is most effective for neuropathic pain (nerve damage), typically when the pain is of non-malignant origin (i.e. a source other than cancer) and is affecting the trunk or limbs.
Normally, any pain treatment involving surgical procedures will only be employed after simpler, less invasive methods have failed to relieve the pain.
It is important to remember that all surgery carries risks including infection and other complications.
The Restore System is the latest advancement to join the Medtronic portfolio of neurostimulation and pump pain therapies. Along with Restore, a wide range of Medtronic pain therapies are currently available to clinicians specialising in the management and treatment of chronic pain.
Medtronic's neurostimulation therapy has already achieved worldwide medical acceptance for the management of chronic, intractable, unilateral or bilateral pain associated with many conditions. Patients can obtain information on chronic pain and the treatments available at www.tamethepain.com.au.
For more information or to arrange an interview contact Kerryn Welsh on 0414 183 703.
About Medtronic, Inc.
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.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Quarterly Report on Form 10-Q for the quarter ended January 27, 2006. Actual results may differ materially from anticipated results.