PR Newswire02.27.19
eNeura Inc., a privately held medical technology company, announced today that it has obtained a new 510(k) clearance from the U.S. Food and Drug Administration (FDA). This new marketing clearance expands the product indication of acute and preventive treatment of migraine to include children 12 years of age and older. The company received clearance for acute and preventive treatment of migraine in adults in 2017.
With this FDA clearance, the sTMS is now the only migraine product in the United States indicated both for the acute and prophylactic treatment of migraine headache in adults and children (12 years of age and older). More than four million children, 12 years and age and older suffer from migraine headache in the US and more than 36 million people in the US suffer from migraine headache.
sTMS 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. Treatment with the portable, patient-controlled sTMS 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. Clinical trials have shown sTMS is as effective as migraine medications but without the risks or unwanted side effects.
"The clearance of our sTMS product for both acute treatment and prevention of migraine in children as young as 12 years old is a breakthrough for migraine headache patients in the U.S.," commented Dr. David K. Rosen, president and CEO of eNeura. "Until now, children have had very few safe and effective options for the treatment and prevention of migraine. Typically, migraine patients, including children, have had to use combinations of pharmaceutical products, each with potentially unpleasant and often disabling side-effects, to prevent headache and treat acute headache attacks. sTMS 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 expansion of the label to include children 12 years of age and older was supported, in part, by the FDA's review of eNeura's ESPOUSE Study, which was conducted in adult patients at eight leading U.S. Headache Centers. Following a protocol of daily use, 46 percent of patients reported at least a 50 percent reduction in headache attacks. There were no serious adverse events reported during the study.
With this FDA clearance, the sTMS is now the only migraine product in the United States indicated both for the acute and prophylactic treatment of migraine headache in adults and children (12 years of age and older). More than four million children, 12 years and age and older suffer from migraine headache in the US and more than 36 million people in the US suffer from migraine headache.
sTMS 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. Treatment with the portable, patient-controlled sTMS 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. Clinical trials have shown sTMS is as effective as migraine medications but without the risks or unwanted side effects.
"The clearance of our sTMS product for both acute treatment and prevention of migraine in children as young as 12 years old is a breakthrough for migraine headache patients in the U.S.," commented Dr. David K. Rosen, president and CEO of eNeura. "Until now, children have had very few safe and effective options for the treatment and prevention of migraine. Typically, migraine patients, including children, have had to use combinations of pharmaceutical products, each with potentially unpleasant and often disabling side-effects, to prevent headache and treat acute headache attacks. sTMS 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 expansion of the label to include children 12 years of age and older was supported, in part, by the FDA's review of eNeura's ESPOUSE Study, which was conducted in adult patients at eight leading U.S. Headache Centers. Following a protocol of daily use, 46 percent of patients reported at least a 50 percent reduction in headache attacks. There were no serious adverse events reported during the study.
