The device, which was the 1st implantable neurostimulation therapy to win CE Mark clearance for pain relief in cluster headache and certain types of migraines, is now indicated for pain relief in migraine patients who are disabled by attacks. These patients tend to experience predominately unilateral orbital or temporal pain, pain free periods between typical attacks or the presence of cranial autonomic symptoms, the company said.
The device’s expanded indication was supported by clinical data from a feasibility study.
“We are delighted to receive this expansion of our CE mark for the use of the Pulsante SPG microstimulator system for people suffering from migraine,” president & CEO Niamh Pellegrini said in prepared remarks. “With this new indication, we will partner with clinicians to better understand the efficacy of Pulsante therapy for migraineurs and look forward to continued study.”
The company won CE Mark clearance for its device in 2012 for acute pain relief of cluster headache.
The regulatory win was supported by data from the company’s Pathway CH-1 study and more than 400 patients have since received the therapy.
Long-term follow-up data demonstrated the therapy’s efficacy, Autonomic Technologies said, and more than 60% of patients enrolled in the study maintained their therapeutic response and decreased use of medication after 2 years.
The post Autonomic Technologies wins expanded CE Mark for migraine-treating microstim appeared first on MassDevice.
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