St Jude Medical has received European CE mark approval for its Genesis neurostimulation device for peripheral nerve stimulation of the occipital nerves associated with intractable chronic migraine.
The approval was backed by the 157-patient randomised, double-blind, controlled study, which demonstrated that patients in the active group reported an average of seven fewer headache days a month as measured by the Migraine Disability Assessment questionnaire compared with only a one day per month decrease in the control (non-stimulation) group.
In addition, it is also found that there was showed a 41% improvement in overall disability in the active group after 12 weeks of stimulation, compared with a 13% improvement in the control group.
St Jude Medical neuromodulation division president Chris Chavez said that the CE mark was the first approval by a regulatory body for the use of neurostimulation to manage the debilitating symptoms of intractable chronic migraine.
”We will continue to work with regulatory authorities to secure approvals in order to offer this therapy option to patients throughout the world,” Chavez said.