Press Release Source: Medtronic, Inc.
Medtronic Boosts Portfolio of Implantable Pain Therapies with Latest FDA Approval
Wednesday June 15, 10:38 am ET
Release of SynergyPlus+(TM) enhances therapy options for people with chronic pain
MINNEAPOLIS–(BUSINESS WIRE)–June 15, 2005– Medtronic, Inc. (NYSE:MDT – News) today announced U.S. Food and Drug Administration (FDA) approval and U.S. availability of its SynergyPlus+(TM) 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. This advancement allows the world leader in pain management technology to better meet the growing needs of chronic pain patients and their physicians.
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.
SynergyPlus+ has the greatest number of program options (up to 26) available of any non-rechargeable neurostimulation system on the market today. 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 customization 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+ is the only system with diagnostic capabilities that allow physicians to assess the way patients use the system to fine tune delivery of pain-blocking stimulation.
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 quality of life. Beyond the physical disability that often results, it can lead to difficulty holding a job, low self-esteem, strained relationships, depression, and suicide.
About the SynergyPlus+(TM) Neurostimulation System
SynergyPlus+ is the next generation of Medtronic’s Synergy(TM) system, the neurostimulation device that helped legendary performer and comedian Jerry Lewis overcome nearly 40 years of chronic pain due to decades of performing physical comedy routines.
The SynergyPlus+ system is indicated as an aid in the management of chronic, intractable unilateral or bilateral pain of the trunk and/or limbs that is associated with: failed back syndrome, low back syndrome or failed back, radicular pain syndrome, post laminectomy pain, multiple back operations, unsuccessful disc surgery or degenerative disc disease, peripheral causalgia, epidural fibrosis, arachnoiditis or lumbar adhesive arachnoiditis, and Complex Regional Pain Syndrome (CRPS).
For more information on chronic pain and Synergy Plus+, visit http://www.tamethepain.com or call 800-510-6735.
About Medtronic Neurological Pain Therapies
The SynergyPlus+ system is the latest advancement to join the Medtronic portfolio of neurostimulation and pump pain therapies. Medtronic offer a variety of pain therapies that are currently available to clinicians specializing in the management and treatment of chronic pain, including Restore(TM), the longest-lasting and most powerful rechargeable neurostimulation system available.
Medtronic also offers a line of intrathecal pain-control pumps, called SynchroMed EL® and SynchroMed® II, which release medication at programmable rates to an area around the spinal cord.
Medtronic’s neurostimulation therapy has already achieved worldwide medical acceptance for the management of chronic, intractable, unilateral or bilateral pain associated with many pain-related conditions.
Medtronic, Inc., (www.medtronic.com) headquartered in Minneapolis, is the world’s leading medical technology company, providing lifelong solutions for people with chronic disease.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 30, 2004. Actual results may differ materially from anticipated results.
Medtronic, Inc., Minneapolis
Kyra Schmitt, 763-505-0237
Rob Carson, 763-505-2705
Source: Medtronic, Inc.
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