NATICK, Mass., Nov. 10 /PRNewswire-FirstCall/ -- Boston Scientific Corporation today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to begin a prospective, randomized, double-blind pivotal trial to evaluate the safety and efficacy of occipital nerve stimulation as a treatment for refractory migraine headache. The study, known as PRISM (PRecision Implantable Stimulator for Migraine), will use Boston Scientific's Precision neurostimulator and involve approximately 150 patients at up to 15 sites in the U.S.
The Precision device is the smallest rechargeable neurostimulator on the market today and is already approved by the FDA for spinal cord stimulation to treat chronic pain. In the PRISM study, the Precision neurostimulator will be used to deliver electrical impulses to the occipital nerves located just under the skin at the back of the neck. Occipital nerve stimulation is intended to treat migraine headache in patients who do not respond to other therapies. There are more than 28 million migraine sufferers in the U.S. and up to 10 percent of these patients may not respond to existing treatments.
"Occipital nerve stimulation has the potential to provide relief to the large population of refractory migraine sufferers who currently have no other medical treatments available to them," said Dr. David Biondi, Director of the Headache Management Program at Spaulding Rehabilitation Hospital in Boston and Instructor of Neurology at Harvard Medical School. "If effective, the Precision implantable neurostimulator would provide a new treatment option to free these patients from their long-standing headache pain."
"As the smallest rechargeable neurostimulator available, our Precision device represents a best-in-class neuromodulation technology that has treated more than 2,000 patients suffering from chronic pain," said Jeffrey H. Greiner, President of Boston Scientific's Neuromodulation Group. "We are excited about the prospect of extending this same advanced technology to address the unmet needs of migraine sufferers."
About the Precision(R) Implantable Neurostimulator
The Precision neurostimulator is currently FDA approved and marketed for spinal cord stimulation to treat chronic pain by precisely delivering tiny electrical signals to the spinal cord that mask the perception of pain. Spinal cord stimulation is prescribed for patients with chronic pain in the limbs, trunk and back. Patients interested in learning more can 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. Boston Scientific's Neuromodulation Group is a global leader in the development of implantable, high-technology neurostimulation devices that include new treatments for deafness and chronic pain. For more information, please visit http://www.bostonscientific.com and http://www.advancedbionics.com.
This press release contains forward-looking statements. Boston Scientific wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with new product development and commercialization, clinical trials, intellectual property, regulatory approvals, competitive offerings, Boston Scientific's overall business strategy, and other factors described in Boston Scientific's filings with the Securities and Exchange Commission.
CONTACT: Milan Kofol 508-650-8569 Investor Relations Boston Scientific Corporation Paul Donovan 508-650-8541 Media Relations Boston Scientific Corporation Boston Scientific Corporation
CONTACT: Milan Kofol, Investor Relations, +1-508-650-8569, or PaulDonovan, Media Relations, +1-508-650-8541, both of Boston ScientificCorporation
