In 2014, the FDA approved the Spring single pulse transcranial magnetic stimulation (sTMS) device for the acute treatment of Migraine with aura. The device worked by delivering magnetic pulses, one at a time, to the back of the head to disrupt the cortical spreading depression that powers Migraine attacks.
The FDA requires separate clinical trials to approve a medication or device for more than one purpose. Acute and preventive Migraine treatment are different indications, so after the FDA approval for acute treatment, eNeura began clinical trials of TMS for Migraine prevention.
With those trials successfully completed, eNeura received FDA approval of their sTMS mini device for migraine prevention last week. The FDA approval states that the sTMS device is now “indicated for the acute and prophylactic treatment of Migraine headache.” This makes it the first device to win FDA approval for both acute and preventive treatment.
The design of the device has evolved since its approval for acute treatment. With those changes has come a change in what the device is called. You can see both the original and the redesigned devices below. The original Spring TMS device had handles that folded against the device for storage. There were buttons on the handles that were pressed to deliver a magnetic pulse. When the pulse was delivered, there was a very loud click.
The new sTMS mini, pictured on the right, has the delivery buttons on the device itself, and the handles have been removed. This makes it far less awkward to handle the device. The click the device makes when delivering a magnetic pulse is much softer. The buttons used to turn on and charge the device are better placed and easier to press on the sTMS mini.
Credit: eNeura, Inc.
Credit: eNeura, Inc.
I asked UCNS certified Migraine and headache specialist David Watson, MD, for his thoughts on the approval of the sTMS mini for Migraine prevention. He told me,
“It is always exciting when new therapies are approved for Migraine disease. While the TMS device has been available to treat attacks of Migraine with aura, the expansion of its use to prevent Migraine attacks is wonderful news. People with Migraine disease have been offered too little for too long, and this is another step in correcting this.”2
David K. Rosen, MD, President and CEO of eNeura, commented,
“The addition of Migraine prevention to our label is a breakthrough for Migraine patients in the U.S. sTMS provides the first-ever migraine product indicated for both acute treatment and prevention of Migraine. 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 Migraine and treating acute Migraine attacks. sTMS from eNeura 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.”
As with other Migraine treatments, the sTMS mini isn’t going to work for everyone. For me, it’s the best preventive treatment I’ve ever used. It’s more effective and less expensive than other preventive regiments I’ve had, and I’m very glad to not need to rely on triptans when I get a Migraine. During the time it took for the device to work well for me preventively, I didn’t need to worry about how many days a week I used it to abort Migraine attacks because it cannot cause medication overuse headache.
One of the most frequent topics of discussion since the approval of the Spring device for acute Migraine treatment is insurance coverage. Whether insurance companies are covering the device isn’t a simple question. Some are covering it; others aren’t. My insurance company does cover it, and my copayment for a 90-day sTMS mini prescription is $300, which is significantly less than the $500+ copayment I was paying every 90-days for Botox treatments.
My insurance company is also paying out far less for the sTMS mini than they were for Botox. My mail-order prescription medication company is also paying out far less since the device is aborting 85 percent of my Migraines without my having to use triptans. Medicare is not yet covering the device. It’s going to take patients submitting claims and pushing them to recognize the device as an effective and affordable treatment to get Medicare to begin coverage for the device. With FDA approval, insurance companies and Medicare can no longer refuse to cover the device by deeming it “experimental.”
If you’re interested in trying the sTMS mini, ask your doctor. If your doctor isn’t a Spring prescriber, you can check with eNeura to find the prescribing doctor closes to you, or your doctor can contact them about becoming a prescriber by emailing eNeura.
1 Email interview with David K. Rosen, MD, President and CEO of eNeura. July 14, 2017.
2 Email interview with David B. Watson, MD, UCNS certified Migraine and headache specialist. July 18, 2017.
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Teri Robert is a leading patient educator and advocate and the author of Living Well with Migraine Disease and Headaches. A co-founder of the Alliance for Headache Disorders Advocacy and the American Headache and Migraine Association, she received the National Headache Foundation’s Patient Partners Award and a Distinguished Service Award from the American Headache Society. Teri can be found on her website, and blog, Facebook, Twitter, StumbleUpon, Pinterest, LinkedIn, and Google+.