eNeura, a privately held medical technology company, announced today that it has obtained an expanded CE Marking in Europe extending the label for its SpringTMS® device to include migraine prevention.
The label extension adds to the existing SpringTMS CE Marking for acute treatment of migraine and UK National Institute for Health and Care Excellence (NICE) guidance recommending single-pulse Transcranial Magnetic Stimulation (sTMS) for acute and preventative treatment of migraine.
The CE Mark Label Extension decision was based on the review of positive data from a UK post market pilot program, which commenced in June 2011 following receipt of the CE Mark for SpringTMS.
Throughout the pilot program, participating clinicians prescribed SpringTMS specifically to patients with disabling migraine who could not successfully use established treatments for a variety of reasons.
Patients were advised to initiate treatment with SpringTMS as early as possible when experiencing symptoms of migraine, including pain and/or aura symptoms. Some doctors advised patients with a frequent migraine pattern to start daily SpringTMS treatment and review the effect of varying treatment patterns to reach an optimum individual level.
Of the 190 patients surveyed throughout the study (59 with episodic and 131 with chronic migraine), 62% reported pain relief, finding the device effective at reducing or alleviating migraine pain.
At three months there was a reduction in monthly headache days for episodic migraine, from 12 to 9 and for chronic migraine, a reduction from 24 to 16. A reduction in the number of headache days per attack was reported in 102 of 185 patients reporting duration data at 12 weeks. The average reduction was a mean decrease from 2.2 days to 0.7 days per attack. There were no serious or unanticipated adverse events.
"The addition of migraine prevention to our SpringTMS CE Mark in Europe is a significant achievement as it provides migraine patients with an option to prophylactically treat the condition before symptoms arise," commented Dr. David K. Rosen, President and CEO of eNeura.
"Migraine is unique in that it requires both treatment of attacks and strategies to reduce attack frequency for a patient to get true relief. Our post market data indicate that SpringTMS demonstrated a novel ability to treat migraine and reduce frequency. The low risk of side effects and the ease of use of SpringTMS make it an attractive option for migraine patients."
SpringTMS is a prescription-only device that utilizes sTMS to induce very mild electrical currents that may depolarize neurons in the brain. This process is thought to interrupt the abnormal hyperactivity associated with migraine.
The non-invasive, proprietary device is designed for patient use. To treat, the device is placed at the back of the head where the push of a button generates a focused magnetic pulse with the intent to eliminate the pain of a migraine headache. SpringTMS also has 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the acute treatment of pain associated with migraine headache with aura.