Magnet treatment device for migraines approved by FDA
The use-at-home device that treats migraines with a pulse of magnetic energy has shown significant promise in clinical trials.
Mon, Dec 16, 2013 at 12:23 PM
Pity the migraine sufferer. Those afflicted with the dreaded headaches are victim to intense throbbing or pulsing, often accompanied by nausea, vomiting and sensitivity to light and sound. The pain can be debilitating and last for days, often with little recourse to ease the symptoms.
But now that the FDA has approved a new migraine treatment device, relief may be in sight for many migraine sufferers.
"Millions of people suffer from migraines, and this new device represents a new treatment option for some patients," said Christy Foreman, director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health.
The migraine-zapping gizmo, the Cerena Transcranial Magnetic Stimulator (TMS) made by eNeura Therapeutics, will be available to patients through a prescription. The device, which wraps around the back of the head and delivers a brief pulse of magnetic energy, has shown to interrupt the progression of migraines that are preceded by an aura.
Of the 30 million Americans who get migraines, around a quarter of them experience aura before the headache sets in. Described as an electrochemical change occurring in the brain, symptoms of aura can be visual or sensory and commonly include partial loss of vision, as well as seeing patterns, flashing or shimmering lights.
The FDA approved the stimulator following a trial of 201 participants who experienced moderate to strong migraines with aura. Thirty-eight percent of the patients using the device were notably pain-free two hours later, compared to 17 percent of patients who used a placebo device. One day after the start of their migraines, nearly 34 percent of device users said they were pain-free, compared to 10 percent of people who had gone without the treatment.
“I have suffered migraine for nine years, tried a lot of medicines and saw different consultants to no avail,” said Yasmin Bibi, who took part in an earlier trial. “I could be completely debilitated for a whole week, needed time off work and was at my wit’s end. Now the device helps me to cope.”
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