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Implantable Neurostimulation System
FDA Approves Medtronic Synergy(R) Therapy for Chronic Intractable Pain; New Neurostimulation System Offers Customized Pain Management
-- Medtronic, Inc., announced that its Synergy® Neurostimulation System, the first and only totally implantable dual channel therapy designed to aid in the management of chronic intractable pain of the trunk or limbs, has been approved by the U.S. Food and Drug Administration (FDA).
Successfully controlling chronic intractable pain, such as low-back pain, has been challenging and costly to the healthcare system. According to the newly released book ``Managing Low Back Pain,'' $280 million is spent annually on surgery for chronic back pain patients. Approximately 950,000 spine surgeries will be performed in 1999 with an estimated success rate of 85 percent. The remaining 15 percent of patients will have unresolved pain. Synergy, which is effective at controlling neuropathic pain (defined as pain resulting from nerve damage), offers hope to these patients.
``Today, patients often move from practice to practice without finding relief for their pain until they can find a physician who is knowledgeable and skilled about an appropriate pain treatment,'' said Dr. Joshua Prager, M.D., director of the California Pain Medicine Center and UCLA School of Medicine. ``With Synergy, the stimulation can be individually customized to deliver appropriate levels of stimulation to the area of pain.''
Synergy is a totally implantable medical device, like a pacemaker, with increased programming capacity (compared to other implantable technologies).
``Pain management is traditionally one of the most sought after -- and least successful -- treatment options in medicine because most therapies are uniformly applied to all patients,'' said Cliff Owens, vice president and general manager of Medtronic's Neurostimulation Business. ``We designed Synergy to provide physicians with the ability to tailor the therapy to more effectively manage patients' pain.''
The Medtronic Synergy Neurostimulation System consists of an implantable pulse generator (IPG), which contains a special battery and electronics that deliver electrical pulses. The IPG typically is implanted under the skin in the lower abdomen and is connected to two medical wires, called leads, which are implanted near the spinal cord. The patient is able to program the appropriate level of stimulation (within prescribed limits set by the physician) and also can turn the system on and off using a hand-held programmer. This technology also allows the therapy to be adjusted non-invasively over time to adapt to changes in pain patterns.
Synergy expands the array of pain management solutions available to multidisciplinary centers treating chronic pain patients. The system offers the following benefits over current implantable technologies:

Adaptability -- It can be used as a single lead system or as a dual channel system.
Flexibility -- Dual channels and transverse (between lead) stimulation allow physicians to adapt the therapy to their patients' pain.
Longevity -- When used as a single lead system, Synergy lasts approximately twice as long as current technologies, depending upon the level of the individual settings.
Studies have shown other neurostimulation systems to be safe and effective in the management of chronic back or leg pain. Fifty-two to 66 percent of patients treated with neurostimulation experience a reduction of half to three-quarters of their pain. Some potential adverse events associated with neurostimulation include a risk of infection, stimulation in the wrong location or a return of the pain.
Synergy is effective at treating neuropathic pain; it is not designed to treat muscle pain.
SOURCE: Medtronic, Inc.
Nov. 22 , 1999

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