Healthcare Industry News: U.S. Food and Drug Administration
News Release - September 7, 2017
eNeura, Inc. Receives FDA Clearance for Use of SpringTMS(R) for Migraine PreventionSpringTMS is the only product available to patients in the United States for both acute treatment of migraine and migraine prevention
eNeura to exhibit at the 18th Congress of the International Headache Society (IHC2017)
BALTIMORE, Sept. 7, 2017 -- (Healthcare Sales & Marketing Network) -- eNeura, Inc., a privately held medical technology company, announced today that it has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) that states: "The eNeura Spring TMS is indicated for the acute and prophylactic treatment of migraine headache." With this FDA clearance the SpringTMS is the only product in the United States indicated both for the acute and prophylactic treatment of migraine headache.
SpringTMS is a non-invasive, prescription-only device that utilizes single-pulse Transcranial Magnetic Stimulation (sTMS) to induce a mild electric current that modulates nerve cells in the brain. This safe, non-invasive technology is believed to interrupt the brain hyperactivity associated with migraine. Treating with the portable, patient use SpringTMS device is painless, easy and takes just a few seconds. Patients place the device at the back of the head, and with the simple push of a button, deliver a focused magnetic pulse to treat a migraine attack and or to prevent the onset of future migraine attacks. SpringTMS also has CE Marking in Europe for the acute treatment of migraine and migraine prevention.
"The addition of migraine prevention to our SpringTMS label is a breakthrough for migraine headache patients in the U.S. SpringTMS provides the first-ever migraine product indicated for both acute treatment and prevention of migraine," commented David K. Rosen, President and CEO of eNeura. "Until now, migraine patients in the U.S. had to use multiple pharmaceutical products, each with potentially unpleasant side-effects, to manage both the challenge of preventing headache and treating acute headache attacks. SpringTMS is now labeled to address the entire spectrum of migraine with an easy-to-use device, that in multiple clinical studies, has proven to be safe and effective."
The extension to the SpringTMS 510(k) decision was supported by the FDA's review of eNeura's post-market ESPOUSE (eNeura SpringTMS Post-market Observational U.S. Study of Migraine) Study, which was conducted at eight leading U.S. Headache Centers on 132 migraine patients. Data from the study indicated that patients following a protocol of daily use of the SpringTMS device reported an average reduction from nine headache days per month at baseline to six days post treatment. In addition, 46% of patients reported at least a 50% reduction in headache attacks. There were no serious adverse events reported during the study. Publication of the full data set is expected later in 2017.
eNeura, Inc. is a privately held medical technology company that is pioneering the use of portable, non-invasive Transcranial Magnetic Stimulation devices for treatment of migraine. SpringTMS is a prescription-only device that utilizes single-pulse Transcranial Magnetic Stimulation (sTMS) to induce very mild electrical currents that can depolarize neurons in the brain. This process is thought to interrupt the abnormal hyperactivity associated with migraine. Prescribed by physicians but designed for patient use, it is the first truly portable, convenient TMS product that will allow migraine patients to administer treatment as needed—at home, in the office or on the go. SpringTMS is now approved in the U.S. and Europe for both the acute treatment of migraine and migraine prevention. For more information about eNeura, please visit http://www.eneura.com.
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