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.

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