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The objective of the study is to demonstrate the long-term safety and performance of the ATI Neurostimulation System when used for stimulation of the sphenopalatine ganglion (SPG) in cluster headache subjects.
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Layout table for eligibility information
Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects who have been implanted with an ATI Neurostimulator as a part of the Pathway CH-1 trial, who have completed the Pathway CH-1 trial, and who remain implanted with an ATI Neurostimulator.
Subject has been implanted with an ATI Neurostimulator as a part of the Pathway CH-1 trial.
Subject has completed the Pathway CH-1 Open Label Final office visit and remains implanted with an ATI Neurostimulator.
Subject has the ability to read, comprehend and to reliably record information as required by the Protocol.
Subject is able to provide written informed consent prior to participation in the study.
Subject has or requires a pacemaker/defibrillator or other implantable device having a sense amplifier that is programmed 'On.'
Subject is not suitable for the study for any reason in the judgment of the Investigator.