Pipeline™ Flex Embolization Device With Shield Technology™ Clinical Study (PFLEX)
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Neuroradiologists and surgeons practice
Subject has provided written informed consent using the IRB/EC-approved consent form and agrees to comply with protocol requirements.
Age 18-80 years.
Subject has already been selected for flow diversion therapy as the appropriate treatment.
Subject has an unruptured target intracranial aneurysm (IA).
Subject has a target IA located in the anterior or posterior circulation.
Major surgery in the past 30 days.
Any known contraindication to treatment with the Pipeline™ Flex embolization device with Shield Technology™ per Instructions for Use.
Pregnant or breast-feeding women or women who wish to become pregnant during the length of study participation.