Autonomic Technologies (ATI) commenced a European study to demonstrate the safety and efficacy of its investigational neurostimulation system, designed for the treatment of high frequency, high disability migraines.
The ATI neurostimulation system is a rechargeable system, with a miniaturised implantable stimulator approximately the size of an almond.
The lead tip of the implant is placed at the sphenopalatine ganglion (SPG) nerve bundle deep in the face on the predominant side of the headache to relieve severe headaches.
Using an external remote controller similar in size to a large cell phone, patients deliver stimulation as required to relieve the headache.
The multicentre randomised Pathway M-1 study will enrol at least 30 patients who have a minimum of four migraine attacks a month and experience migraine pain on at least eight days each month.
Currently, the ATI neurostimulation system is being evaluated in the Pathway CH-1 study for the treatment of cluster headache, an extremely severe headache disorder.
Interim data from the study indicated that using the company's neurostimulation system, 59% of patients demonstrated pain relief, with a 50% reduction in headache frequency in 63% of patients treated.
Autonomic Technologies president and CEO Ben Pless said based on the results of the device for cluster headaches, ATI and the investigator team had begun clinical work with migraine patients. The US Food and Drug Administration (FDA) approved investigational use of the ATI neurostimulation system in the US for treatment of cluster headaches.
The company expects to receive the European CE mark for use of the ATI neurostimulator in treating cluster headache in the near future. Autonomic Technologies is a San Francisco Bay Area based medical device company focused on the development of a miniaturised implantable stimulator for severe headaches.