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Home Treated Conditions Migraine St. Jude Medical Receives CE Mark Approval of Eon Mini to Treat Chronic Migraine
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St. Jude Medical Receives CE Mark Approval of Eon Mini to Treat Chronic Migraine

St Jude Medical Eon and Eon Mini Spinal Cord StimulatorsSt. Jude Medical announced it has received European CE Mark approval of its Eon™ family of neurostimulators for treating patients with intractable chronic migraine.

According to the press release:

“Intractable chronic migraine is one of the most difficult-to-treat headache disorders,” said Professor Gennaro Bussone, M.D., head of the Neurological Department at Istituto Besta in Milan Italy. “By definition, people living with this condition are spending half their month living with debilitating headaches. This therapy expands our options in helping manage patients who suffer with disabling chronic migraine symptoms.”

The Eon and Genesis systems deliver peripheral nerve stimulation (PNS) of the occipital nerves to manage the pain and disability associated with intractable chronic migraine. This type of migraine is defined as headache lasting at least four hours per day for 15 or more days per month, causing at least moderate disability, and not responding to three or more preventive drugs. PNS therapy for this condition involves the delivery of mild electrical pulses to the occipital nerves that are located just beneath the skin in the back of the head. A small electrical lead or leads are placed under the skin and connected to the neurostimulator, which produces the pulses of stimulation.

Eon Mini Implantable stimulator used for migraine prevention www.implantable-device.com David Prutchi Ph.D.

Prior to receiving these approvals, St. Jude Medical conducted a large scale double-blind, randomized, controlled clinical study evaluating PNS to treat the pain and disability associated with chronic migraine. After 12 weeks of stimulation, patients reported an average of six fewer headache days a month. After one year of stimulation, 65 percent of patients reported excellent or good pain relief and 89 percent said they would recommend the procedure to someone else. Study data were presented at the International Headache Congress in 2011 and have been accepted for publication.

“Neurostimulation technology represents an exciting new approach to treat intractable chronic migraine,” said Eric S. Fain, M.D., president of the St. Jude Medical Implantable Electronic Systems Division. “We are proud to be able to offer this potentially life-changing therapy for patients who suffer with this debilitating condition and so desperately need a more effective treatment option.”

October 3, 2012 RELATED INFORMATION: St. Jude Press release:

St. Jude Medical’s Peripheral Nerve Stimulation Study Confirms Benefit for Chronic Migraine Patients

Data published today in Cephalagia shows significant reductions in pain, headache days and migraine-related disability

ST. PAUL, Minn.–(BUSINESS WIRE)–Oct. 3, 2012– St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced publication of results from the first large-scale study of peripheral nerve stimulation (PNS) of the occipital nerves in patients suffering from chronic migraine. The study results, published online by Cephalalgia the journal of the International Headache Society, show a significant reduction in pain, headache days and migraine-related disability.

Conducted at 15 medical centers in the U.S., the study followed 157 participants who, on average, suffered from headache approximately 21 days per month. At 12 weeks, patients receiving PNS therapy reported an average of six fewer headache days a month.

Additional key findings at 12 weeks were as follows:

43 percent improvement in overall disability scores, as measured using the Migraine Disability Assessment questionnaire (MIDAS)

53 percent of the patients ranked their relief as excellent or good

Patients reported a 42 percent improvement in pain relief

“One of the primary reasons that patients seek therapy is to try to find a way to lessen the number of days they experience migraine,” 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. “For the millions who suffer from chronic migraine, these study results are important, as they confirm that peripheral nerve stimulation (PNS) of the occipital nerve may help improve their quality of life and lessen the number of days per month they suffer with this debilitating condition.”

PNS therapy for this condition involves the delivery of mild electrical pulses to the occipital nerves that are located just beneath the skin at the back of the head. A small electrical lead or leads are placed under the skin and connected to a neurostimulator, which produces pulses of stimulation.

In this prospective, randomized, controlled study, participants were implanted with the St. Jude Medical Genesis™ neurostimulator and randomly assigned to an active or control group for 12 weeks. The active group received stimulation immediately upon implantation, while patients in the control group did not receive stimulation until after the first 12 weeks. Both the investigators and the patients were blinded to treatment.

Although statistical significance was demonstrated across most measures, it was not observed for the primary endpoint (defined as the difference in the percentage of patients in the active group versus control who achieved 50 percent or greater pain reduction at 12 weeks). However, patients in the active group were more likely than control patients to experience 30 percent or greater pain reduction, which is considered clinically meaningful.

“When this study was initially designed, the primary endpoint was based on a reduction in pain, which at the time was the standard measurement for neurostimulation studies,” said, Dr. Mark Carlson, chief medical officer and senior vice president of research and clinical affairs for the St. Jude Medical Implantable Electronic Systems Division. “However during the course of the study, many neurologists began to recognize reduction in the number of headache days as a more significant improvement in patient quality of life than the measurement of pain reduction alone.”

The most common adverse event was persistent pain and/or numbness at the implant site, followed by lead migration. The majority of adverse events were classified as mild or moderate in severity.

Preliminary data from this study was presented at the International Headache Congress (IHC) in 2011. The Genesis neurostimulation system used in this study is approved in Europe and Australia for the management of the pain and disability associated with intractable chronic migraine.

 

 

 

 
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