Migraines are a common problem, with an estimated 11% of the population in Western Europe and the U.S. suffering from the condition. A number of drug- and devicemakers are jumping into the market; Allergan's ($AGN) Botox is FDA-approved as a migraine preventive, while St. Jude Medical ($STJ) has the CE Mark for its neurostimulation device.
Now, Autonomic Technologies has reported the start of a 30-patient European study evaluating the safety and efficacy of its investigational neurostimulation system for the treatment of high-frequency, high-disability migraines. The trial will enroll subjects in Denmark, Belgium, Spain, France and Germany.
The investigational ATI neurostimulation system includes an almond-sized implantable stimulator that is designed to treat cluster headaches and migraines. The neurostimulator is delivered through a surgical incision in the gum, leaving no external scars. Patients can self-deliver stimulation when needed to alleviate their headaches.
"Current migraine treatments include preventive and acute abortive drugs, but these are not effective for all migraine sufferers," Dr. Rigmor Hoejland Jensen, director of the Danish Headache Center at Glostrup Hospital in Denmark and study principal investigator, explained in a statement. He adds that some migraine sufferers can't even get relief from these drugs because of cardiovascular conditions, so the Autonomic device could hold great hope for these patients.
The neurostimulation system is also being evaluated as a treatment of cluster headaches. Autonomic hopes to win CE Mark approval for its system to treat cluster headaches shortly. The FDA has approved investigational use of the ATI system as a treatment of cluster headaches.
Redwood City, CA-based Autonomic has a number of big name financial backers behind it: Kleiner Perkins Caufield and Byers, InterWest Partners, Versant Ventures, Novartis Ventures, Aberdare Ventures and the Cleveland Clinic. In October, the company closed a $32 million round of financing, the proceeds of which were earmarked for European trials and to start studies in the U.S.
- read Autonomic's release
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