Healthcare Industry News: rechargeable neurostimulator
News Release - April 17, 2006
Boston Scientific Announces First Patient Implanted in Clinical Trial Assessing Neurostimulation as a Treatment for MigraineNew study seeks to define potential of Precision(TM) system to treat large population of U.S. migraine sufferers who don't respond adequately to current therapies
NATICK, Mass., April 17 (HSMN NewsFeed) -- Boston Scientific Corporation (NYSE: BSX ) today announced that the first patient in the PRISM (Precision® Implantable Stimulator for Migraine) clinical trial was implanted. This pivotal trial will assess the safety and efficacy of occipital nerve stimulation as a treatment for refractory migraine headache, and will use Boston Scientific's Precision(TM) neurostimulation system to treat migraine patients who do not respond to other available therapies, or who cannot tolerate the side effects of existing medications. The Precision® implantable pulse generator will deliver electrical impulses to the occipital nerves located just under the skin at the back of the neck.
The first person to receive an implant in the trial was a 52 year-old woman who currently experiences more than 20 headache days per month, and has suffered from headaches for the last 32 years. The implant was performed by Benjamin Lampert, M.D., Director of the Center for Pain Management at St. John's Hospital in Springfield, MO. "Occipital nerve stimulation may provide a valuable option for pain relief to headache sufferers who otherwise have no remedies available," said Dr. Lampert.
"This randomized, placebo-controlled trial is an important step to providing scientific validation for the use of neurostimulation as a treatment for migraines," said Roger Cady, M.D., Director of Clinvest and the Headache Care Center in Springfield, MO, and an investigator in the study. "If shown effective, this therapy will positively impact the lives of a large group of people with migraine who don't respond well to conventional pharmacotherapies."
"More than 4,000 pain sufferers are benefiting from the Precision system, and we are committed to making this same technology available to provide headache relief to migraine patients," said Jeff Greiner, President of Boston Scientific's Neuromodulation Group.
The Precision neurostimulation system is the smallest rechargeable neurostimulator approved by the U.S. Food and Drug Administration (FDA) for spinal cord stimulation to treat intractable chronic pain of the trunk and limbs. The use of the Precision neurostimulation system for treatment of refractory migraine headache is considered investigational and limited by Federal law to investigational use only in the United States.
More than 28 million people suffer from migraine in the U.S., with an estimated 10 percent of these patients failing to receive sufficient relief from existing forms of therapy, leaving many unable to work or perform daily life activities. It is estimated that migraine costs employers more than $13 billion annually due to missed work and reduced productivity. The PRISM trial will study the benefits of stimulation in approximately 150 refractory migraine patients who will receive implants at 15 centers across the U.S. Individuals interested in learning more about the trial can call (800) 387- 0385 or email MigraineStudy@advancedbionics.com.
About the Precision(TM) Implantable Neurostimulator
The Precision neurostimulator is FDA approved and marketed for spinal cord stimulation to treat chronic intractable pain of the trunk and/or limbs. It is designed to precisely deliver tiny electrical impulses to the spinal cord that mask the perception of pain. To learn more about this device please visit http://www.ControlYourPain.com.
About Boston Scientific Corporation
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. The Neuromodulation Group is a global leader in the development of implantable, high-technology neurostimulation devices that include treatments for deafness and chronic pain. For more information, please visit http://www.bostonscientific.com and http://www.advancedbionics.com.
Forward Looking Statements
This press release contains forward-looking statements, including statements as to regulatory approvals for the merger, timing expectations to complete the merger and other statements identified by words such as "anticipates", "believes", "estimates", "expects", "intends", "may", "projects", "plans", "will" and similar expressions intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the satisfaction of other closing conditions contained in the merger agreement and other risk factors relating to our industry as detailed from time to time in each of Boston Scientific's and Guidant's reports filed with the Securities and Exchange Commission, including each such company's most recent Annual Report on Form 10-K. You should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Unless legally required, Boston Scientific undertakes no obligation to update publicly any forward-looking statements herein, whether as a result of new information, future events or otherwise.
Source: Boston Scientific
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