European regulators have have approved St. Jude Medical‘s Eon line of neurostimulators for people with intractable chronic migraines. For those who’ve failed a three-drug regimen, the answer may lie in this tiny device, that stimulates the occipital nerve.
The approval covers the Eon Mini, the world’s smallest rechargeable neurostimulator, and the Eon and EonC. The company previously received EU clearance to treat chronic migraines with the Genesis neurostimulator, the first device to receive such clearance.
From the announcement:
The Eon and Genesis systems deliver peripheral nerve stimulation (PNS) of the occipital nerves to manage the pain and disability associated with intractable chronic migraine. This type of migraine is defined as headache lasting at least four hours per day for 15 or more days per month, causing at least moderate disability, and not responding to three or more preventive drugs. PNS therapy for this condition involves the delivery of mild electrical pulses to the occipital nerves that are located just beneath the skin in the back of the head. A small electrical lead or leads are placed under the skin and connected to the neurostimulator, which produces the pulses of stimulation.
Prior to receiving these approvals, St. Jude Medical conducted a large scale double-blind, randomized, controlled clinical study evaluating PNS to treat the pain and disability associated with chronic migraine. After 12 weeks of stimulation, patients reported an average of six fewer headache days a month. After one year of stimulation, 65 percent of patients reported excellent or good pain relief and 89 percent said they would recommend the procedure to someone else. Study data were presented at the International Headache Congress in 2011 and have been accepted for publication.
Press release: St. Jude Medical Receives European CE Mark Approval of Eon Mini Neurostimulator, the World’s Smallest Rechargeable Device to Treat Chronic Migraine
Flashbacks: Eon Mini, World’s Smallest Spinal Cord Stimulator, Makes Clinical Debut; World’s Smallest Spinal Cord Stimulator Approved in US, Europe; St. Jude’s Eon Mini Becomes First Pain Management Neurostimulator Approved in Japan; Eon Promises Longer Lasting Neurostimulation; Eon™ Rechargeable Neurostimulation System;