St. Jude device eases migraines, but can it convince the FDA?

A device from St. Jude Medical helped reduce the number of days each month migraine patients suffered headaches, according to data presented at the 15th International Headache Congress in Berlin. St. Jude's offering, known as the Genesis neurostimulation system, works by delivering mild electrical pulses from an implanted device to leads placed under the skin at the back of the head, stimulating the occipital nerves.

The study followed 157 participants who, on average, suffered from headache 26 days per month. Study participants were implanted with the Genesis neurostimulator and randomly assigned to an active or control group for 12 weeks. The active group received stimulation immediately upon implant, while patients in the control group did not receive stimulation until after the first 12 weeks.

Patients who received stimulation reported a 28 percent decrease in their number of headache days compared with the placebo group, which reported a 4 percent decrease.

While the results were positive, Wall Street analysts are dubious as to whether they are strong enough to win the FDA's nod for the device in this indication, according to Reuters. 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 not all may be lost for the company--at least in Europe. "The results are, in short, impressive and bode well for European approval later this year and the development of a significant new market for St. Jude," said J.P. Morgan analyst Michael Weinstein, in a research note, as quoted by MedCity News. St. Jude has filed for CE Mark approval of the system for the management of pain and disability associated with chronic migraine and expects to begin a limited launch in Europe later this year.

- get the St. Jude release
- read more from Reuters
- see the MedCity News report

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