By a News Reporter-Staff News Editor at Clinical Trials Week - Autonomic Technologies, Inc. announced that it has received an expanded indication (CE mark) in Europe for the Pulsante SPG Microstimulator System to include pain relief for highly disabled migraine patients. Autonomic Technologies is a global medical device company focused on the development and commercialization of innovative therapies for the treatment of cranial autonomic disorders, initially severe headache (see also Autonomic Technologies, Inc.).
The Pulsante SPG Microstimulator System is the first implantable neurostimulation therapy to receive CE mark for pain relief in both cluster headache and certain types of migraine. Specifically, the Pulsante SPG Microstimulator System is now also indicated for pain relief in migraine patients for whom standard of care treatment is inadequate or contraindicated, and who are disabled by attacks (with or without aura) with one or more of the following characteristics: predominately unilateral orbital or temporal pain, pain free periods between typical attacks, the presence of cranial autonomic symptoms. The expansion in indication was based on 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," said Niamh Pellegrini, President and CEO of Autonomic Technologies. "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."
In 2012, the Pulsante Microstimulator System received CE mark for acute pain relief of cluster headache, a disabling neurological condition characterized by intense, stabbing pain, typically on one side and often accompanied by swelling, tears, and nasal congestion. The Pulsante System provides acute pain relief for cluster headache using on-demand stimulation of a nerve bundle behind the nose known as the sphenopalatine ganglion (SPG). The CE mark for acute pain relief of cluster headache was based on robust clinical evidence from the Pathway CH-1 study1, and to date, more than 400 patients have received the therapy. Recently published, long-term follow-up data2 reaffirms the effectiveness of the therapy, with more than 60 percent of the patients enrolled in the study maintaining their therapeutic response and decreased use of medication at 24 months.
Keywords for this news article include: Therapy, Pain Management, Cluster Headache, Clinical Research, Headache Disorders, Headache and Migraine, Neurologic Manifestations, Autonomic Technologies Inc., Clinical Trials and Studies, Brain Diseases and Conditions, Trigeminal Autonomic Cephalalgias, Primary Headache Diseases and Conditions.
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