Neurology, policy  

Medtronic receives FDA approval for rechargeable neurostimulation system

12 April 2005

Minneapolis, USA. Medtronic, Inc. (NYSE:MDT) today announced that its Restore Rechargeable Neurostimulation System is now available, following approval granted by the United States Food and Drug Administration (FDA). It is a new treatment option for people suffering from complex, difficult-to-treat chronic pain, and those requiring high-power stimulation for pain relief.

The Restore battery can last for up to nine years, exceeding that of any other rechargeable spinal cord stimulator on the market. And like a cell phone battery, the Restore System's battery can be recharged. 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.

The System's high-power battery offers Restore patients the convenience and flexibility of the longest time between recharge periods. Patients will typically need to recharge the Restore battery approximately once per month, whereas other devices on the market may require recharges as frequently as once per week.

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 an unmatched number of program options — as set by a physician — to meet his or her individual treatment needs.

The launch of Restore marks a significant step forward in the treatment of chronic pain, according to David Caraway, MD, PhD, medical director of the Tri-State Regional Pain Management Service at St. Mary's Hospital, Huntington, WV. "Medtronic's newest spinal cord stimulator should help us treat some of the most complex forms of chronic pain better than we have in the past," says Caraway. "This is welcome news for patients who haven't had much success with other chronic pain treatments. By delivering a high level of sustainable power, this new rechargeable device will provide relief to many who suffer greatly and may be functionally impaired by pain. With this device, the patient controls the pain - the pain doesn't control the patient."

The Restore Rechargeable Neurostimulation System

The Restore System 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.

The device, about the size of a stopwatch, is implanted under the skin. Up to two leads — with eight electrodes each — deliver electrical pulses to the spine. Based on individual patient need, doctors can customize the positioning of the electrodes to deliver stimulation directly to the target area on the spine, and in doing so, block pain signals from reaching the brain. "Restore is the most advanced neurostimulation system on the market today," said Jon Tremmel, president, Medtronic Neurological. "With the Restore System, Medtronic now provides the broadest range of chronic pain management therapies and devices to best address patient needs."

For more information on the Restore Rechargeable Neurostimulation System, visit

About chronic pain

Defined as pain that persists or recurs for more than six months, chronic pain can be caused by a variety of injuries and diseases, and most commonly affects the lower back and legs. Left untreated or under-treated, chronic pain can destroy a person's life. Beyond the physical disability that often results, it can lead to difficulty holding a job, low self-esteem, strained relationships, depression, and suicide.

It is estimated that chronic pain affects approximately 25 percent of the U.S. population. Chronic pain accounts for an estimated $100 billion per year in medical costs, including 515 million lost workdays and 40 million physician visits.

For more information on chronic pain, visit the American Pain Foundation web site at


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