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
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,
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
For more information on chronic pain, visit the American Pain Foundation
web site at www.painfoundation.org