ST. PAUL, Minn., Jun 23, 2011 (BUSINESS WIRE) -- St. Jude Medical, Inc. /quotes/zigman/242119/quotes/nls/stj STJ -4.66% , a global medical device company, today announced study results on the safety and efficacy of peripheral nerve stimulation (PNS) of the occipital nerve for the management of pain and disability associated with chronic migraine, a debilitating condition that affects millions worldwide. Presented at the 15th International Headache Congress in Berlin, Germany, the study shows statistically significant improvement across multiple measures including a reduction in the number of headache days per month and improvement in quality of life. This is the largest clinical study to date evaluating the use of PNS via an implanted medical device for the treatment of chronic migraine.
The study followed 157 participants who, on average, suffered from headache 26 days per month. Study participants were implanted with the St. Jude Medical Genesis(TM) neurostimulator and randomly assigned to an active or control group for 12 weeks. The active group received stimulation immediately upon implant, while patients in the control group did not receive stimulation until after the first 12 weeks. All patients were followed for one year. At one year, 66 percent of patients reported excellent or good pain relief.
At 12 weeks, the study demonstrated the following statistically significant results:
-- Patients who received stimulation reported a 28-percent decrease in their number of headache days (seven less days a month) compared to the placebo group which reported a 4-percent decrease (one less day per month).
-- Overall disability as measured by the Migraine Disability Assessment questionnaire (MIDAS) indicated participants in the active group had a 41-percent improvement compared to a 13-percent improvement in the placebo group.
-- Zung Pain and Disability Index (PAD) scores improved in the active group by 20 percent compared to an 8-percent improvement in the placebo group.
-- In addition to the standardized scales (MIDAS and PAD), patients were asked to subjectively assess their pain relief. The active group reported 42-percent pain relief compared to 17 percent in the placebo group.
-- Patients in the study were asked to define their headache relief as excellent, good, fair, uncertain, or poor. At the 12-week end point, 53 percent of patients in the active group ranked their relief as excellent or good compared to 17 percent in the placebo group.
-- When asked to rate the effect on their quality of life, 67 percent of the active group reported improvement compared to 17 percent in the placebo group.
-- The active group reported 51-percent satisfaction with headache relief compared to 19 percent in the placebo group.
Statistical significance was demonstrated across most measures. It was not however observed in the primary endpoint as established by the U.S. Food and Drug Administration. This was defined as a significant difference between active and placebo groups who reported a 50-percent reduction in pain as measured on a visual analog scale and a minimum 10-percent point difference between the 95-percent confidence intervals comparing the active and placebo groups. A statistically significant difference between the active and placebo groups was observed at the 40-percent reduction in pain level.
"Many migraine patients have exhausted all current treatment options and often are disabled by the pain and frequency of migraine attacks," said Stephen D. Silberstein, M.D., past president of the American Headache Society, director of the Jefferson Headache Center, and the principal investigator in the study. "Achieving a reduction in the number of days they suffer from headache and a significant improvement in their quality of life may be even more important than pain reduction alone. This research demonstrates that peripheral nerve stimulation can ease the suffering of chronic migraine patients."
St. Jude Medical has filed for CE Mark approval of the Genesis neurostimulation system for the management of pain and disability associated with chronic migraine and expects to begin a limited launch in Europe later this year. It is not yet clear when this neuromodulation system will be approved for the treatment of chronic migraine in the U.S. This system delivers mild electrical pulses from an implanted device to leads placed under the skin at the back of the head, stimulating the occipital nerves.
According to the World Health Organization (WHO), 10 percent of adults worldwide suffer from migraine, a disabling condition that can last for hours or days at a time. WHO also estimates 1.7 to 4 percent of adults have headaches on more than 15 days per month. In the U.S. alone, it is estimated that almost 28 million Americans suffer from migraine -- or roughly 13 percent of the population, according to the National Headache Foundation. The severity of each migraine attack can vary widely, with typical symptoms ranging from sensitivity to light, noise and motion, to nausea and vomiting in addition to headache.
Three Decades of Leading-Edge Neurostimulation Technology
For more than 30 years, the St. Jude Medical Neuromodulation Division has developed new technologies to treat chronic pain and other neurological disorders. Today more than 75,000 patients in 40 countries have been implanted with St. Jude Medical neurostimulation systems.
Focused on research, St. Jude Medical is developing new technologies to address a growing list of neurological disorders. Additional clinical studies are currently underway for Parkinson's disease, essential tremor, major depressive disorder, and other significant indications.
About St. Jude Medical
St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn., and has four major focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit www.sjm.com .
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management's current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company's control and the risk factors and other cautionary statements described in the Company's filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company's Annual Report on Form 10-K for the fiscal year ended January 1, 2011 and Quarterly Report on Form 10-Q for the fiscal quarter ended April 2, 2011. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
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SOURCE: St. Jude Medical, Inc.
St. Jude Medical, Inc.
J.C. Weigelt, 651-756-4347
Denise Landry, 972-309-8085