Implantable pain therapy device receives FDA approval
4 July 2005
The U.S. Food and Drug Administration (FDA) has approved the Medtronic
SynergyPlus+ neurostimulation system for chronic pain.
SynergyPlus+ is the newest "pain pacemaker" to join Medtronic's family of
implantable chronic pain therapies. It was designed to give patients more
control over the delivery of stimulation that blocks pain signals from
reaching the brain while performing a variety of daily activities.
Approximately 25 percent of the U.S. population, more than 70 million
people, experience some form of chronic pain. Many of these people remain
unaware of the range of available treatment options. It is estimated that
chronic pain accounts for an estimated $100 billion per year in medical
costs, including 515 million lost workdays and 40 million physician visits.
The SynergyPlus+ has 26 program options, which the company claims is more
than any rechargeable system on the market. Using a small, hand-held "remote
control" programming device, patients can choose among multiple settings
that are preset by a physician to address pain levels associated with
different daily tasks, such as standing, walking or laying down.
"Because chronic pain affects each person differently, it's important to
have a range of therapies designed specifically to treat the individual
needs of any patient," said Dr. Alon Mogilner, Director of Functional and
Restorative Neurosurgery, North Shore University Hospital, New York.
"SynergyPlus+ is the right choice for many of my patients who require low to
moderate levels of stimulation to control their pain."
The device's array of program options provides a level of therapy
customisation that may result in fewer physician follow-up visits, which can
otherwise be required to ensure that the most effective amount of
stimulation is delivered over time. In addition, SynergyPlus+ has diagnostic
capabilities that allow physicians to assess the way patients use the system
to fine tune delivery of pain-blocking stimulation.