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| eNeura's SpringTMS migraine system--Courtesy of eNeura |
Following the FDA's de novo approval of eNeura's device for the treatment of pain from migraine headaches with aura--a decision FierceMedicalDevices designated as one of the agency's biggest in 2013--the company announced May 23 that its second-generation SpringTMS received 510(k) clearance.
The SpringTMS offers improved portability over the first-generation Cerena TMS, eNeura said. Like its predecessor, the prescription-only SpringTMS sends very mild electrical currents into the brain that can depolarize neurons, according to eNeura's statement. Patients use the device by placing it at the back of their head and pushing a button that generates a magnetic pulse.
"The FDA clearance of SpringTMS is a significant accomplishment for eNeura and a tremendous validation of our sTMS [single-pulse transcranial magnetic stimulation] technology. We are very confident that SpringTMS will offer tremendous benefit to many migraine sufferers," eNeura CEO David Rosen said in a statement. "We are excited to introduce this new treatment to patients in the U.S. through our postmarket 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 previous version was granted de novo approval in December 2013, meaning it was the first device of its kind and of low to moderate risk. The FDA cleared it following a double-blind, placebo-controlled, randomized clinical study of 201 patients.
The second-generation SpringTMS device has a CE mark in Europe and was boosted when transcranial magnetic stimulation received a positive recommendation from the U.K. National Institute for Health and Care Excellence (NICE) in March 2013.
eNeura's website says that 70% of migraine patients are unhappy with or cannot tolerate the side effects of medications. According to the Cleveland Clinic, nearly 30 million Americans get migraines, 15% to 20% of them with aura.
In March the FDA gave its first de novo approval for a device to prevent migraines, demonstrating the industry's increasing interest and involvement in the migraine arena.
- read the release
- here's the NICE report (PDF)
Special Report: 2013's top FDA approvals in med tech - eNeura's antimigraine device