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Medical Devices / Submissions and Approvals

Autonomic Technologies Gains Expanded Indication of CE mark for Pulsante SPG Microstimulator System

March 13, 2017
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Autonomic Technologies has received an expanded indication (CE mark) in Europe for the implantable neurostimulation therapy, Pulsante SPG microstimulator system to include pain relief for highly disabled migraine patients.

The device is now indicated for pain relief in migraine patients for whom standard of care treatment is inadequate or contraindicated and who are disabled by attacks with one or more of the following characteristics: predominately unilateral orbital or temporal pain, pain free periods between typical attacks and the presence of cranial autonomic symptoms.

The device is activated using an external remote controller, allowing patients to deliver as-needed stimulation to relieve the attack. — Cynthia Jessup

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