At a glance
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Success in Comaneci-assist Coils Embolization Surveillance Study
In Brief
An observational study evaluating Comaneci Embolization Assist Device for Intracranial Aneurysm. Completed, enrolled 90 participants across 8 sites.
Detailed Summary
The Comaneci Embolization Assist Device is indicated for use in the neurovasculature as a temporary endovascular device used to assist in the coil embolization of wide-necked intracranial aneurysms with a neck width ≤ 10 mm. A wide-necked intracranial aneurysm (IA) defines the neck width as ≥ 4 mm or a dome-to-neck ratio \< 2. The objective of the Postmarket Surveillance Plan is to assess safety and performance as used in postmarket clinical practice in the U.S.
Study Details
Timeline
Interventions
assist in the coil embolization of wide-necked intracranial aneurysms with a neck width ≤ 10 mm.