Maryland medical device maker eNeura today touted FDA clearance for its SpringTMS system, a mobile magnetic stimulator that can help relieve pain associated with migraines that are preceded by an ‘aura.’
The device is the 1st of its kind to use transcranial magnetic stimulation to depolarize neurons on the brain, a process that doctors believe may interrupt migraine activity. Designed for home use, patients place the device against the back of the head, where a magnetic pulse targets the occipital lobe.
Clearance was based on eNeura’s double-blind, placebo-controlled studies in more than 200 patients, which found that nearly 38% of eTMS patients were pain-free 2 hours after using the device, compared with only 17% of patients in the control group. About 34% of eTMS patients were pain-free after 24 hours, compared with 10% of the control patients. Researchers reported no device-related serious adverse events.
"No discernible evidence exists to suggest that [single-pulse] TMS causes harm to humans," researchers wrote in a 2010 study of migraine patients, published in Headache, The Journal of Head & Face Pain.
The SpringTMS device is eNeura’s 2nd generation of migraine-treating TMS technology, following the Cerena system which won FDA clearance late last year. SpringTMS is built on the same technology, but is more portable.
"The FDA clearance of SpringTMS is a significant accomplishment for eNeura and a tremendous validation of our sTMS technology. We are very confident that SpringTMS will offer tremendous benefit to many migraine sufferers," president & CEO Dr. David Rosen said in prepared remarks. "We are excited to introduce this new treatment to patients in the U.S. through our post-market open-label study with leading headache specialists. This strategy will ensure we approach the market in a manner that enables the best outcome for patients using our device."
The FDA has rubber-stamped a handful of migraine devices in recent months. In March the agency approved the Cefaly headband technology for daily use in prevention of migraine headaches.
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