St. Jude Medical ($STJ) has received European CE Mark approval for its implanted neurostimulation device for patients with chronic migraine. The Genesis neurostimulation system is for migraines that last at least four hours a day for 15 or more days per month and have not responded to three or more preventive drugs.
Data from a randomized, double-blind, controlled study that included 157 patients supported the approval. Trial participants suffered from had headaches 26 days per month. At 12 weeks, patients in the active group reported an average of 7 fewer headache days a month compared with only a one day per month decrease in the non-stimulation group.
Results from the study were released earlier this summer, but not everyone was impressed. Many analysts were skeptical whether the company could get FDA clearance for the device in this indication. Statistical significance was not observed in the primary endpoint as established by the FDA, which wanted to see a great reduction in pain in the active group versus the control.
But J.P. Morgan analyst Michael Weinstein saw hope. "The results are, in short, impressive," he said in a note, as quoted by the Pioneer Press. "The chronic migraine market represents a large area of unmet medical needs, and St. Jude is well positioned to capture a first-mover advantage in this potentially meaningful new market opportunity."
- see the St. Jude release
- get more from the Pioneer Press