New device aims to seal brain aneurysms without surgery

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18 22 to 80 years * Subject, or subject's legal representative provided informed consent * Subject agrees to the requirements of the study, including returning for required follow-up visits * Parent artery diameter of 2.0-5.5 mm distal and proximal to the target IA * Subject has a single target IA in the index procedure with the following characteristics: (1) Unruptured; (2) Located in the ICA from the petrous through the superior hypophyseal segments; and (3) Is a fusiform or saccular wide-necked IA with one of the following characteristics: (a) Small (\< 5 mm) or medium (\>5-10 mm) size with a neck width ≥ 4.0 mm or a dome-to-neck ratio of \< 2; OR (b) Large (\>10-25 mm) or giant (\>25 mm) size Exclusion Criteria: * A subarachnoid or intracerebral hemorrhage in the 60 days preceding the index procedure * A bleeding disorder or a platelet count of less than 100x103/mm3 or INR \>1.5 * A contraindication to or inability to tolerate antiplatelet therapy * An allergy to radiographic contrast agents * An allergy to  nickel, titanium, platinum, tungsten, or stainless steel * An allergy to local or general anesthesia * A history of untreated atrial fibrillation, untreated/uncontrollable hypertension, or other stroke risk factors * A history of deep vein thrombosis or pulmonary embolism * A history of heart failure, dilated cardiomyopathy, or congenital heart conditions * Hypercoagulopathy or a hemorrhagic or coagulation deficiency refractory to medical therapy or subject refuses treatment with blood products * Suffered a stroke within 180 days preceding the index procedure * Had major surgery within the 30 days preceding or planned for the 180 days following the index procedure, including but not limited to intracranial stenting or coiling * Target aneurysm has been previously treated with clipping, coiling, or flow diversion * Had previous stenting of or implant in parent artery proximal to the target aneurysm that could interfere with delivery or performance of study device * Asymptomatic extradural aneurysms requiring treatment * Contraindication to computed tomography (CT) or magnetic resonance (MR) * An unstable neurological deficit (i.e., worsening of a clinical condition within the 30 days preceding the index procedure) * Evidence of an active systemic infection (including COVID-19) at index procedure * Dementia or other cognitive condition limiting their ability to participate in the study * A condition that may limit survival to less than 12 months post-index procedure * Serum creatinine ≥2.5 mg/dL * Had radiation or chemotherapy treatment either currently or within the 60 days preceding the index procedure * Current enrollment in a separate clinical trial * Another condition(s) that, in the opinion of the Investigator, could interfere with the ability to perform a safe or effective procedure * Current pregnancy or plan to become pregnant within the 12 months following the index procedure, or be currently breastfeeding Angiographic Exclusion Criteria: * Anatomy not amenable to endovascular treatment, including but not limited to severe vessel tortuosity or stenosis * Parent vessel stenosis is \>50% in the target area * Extracranial stenosis of the carotid artery \>50% * An intracranial mass * More than one vessel segment requiring IA treatment in the 12 months following the index procedure * Target aneurysm is mycotic or dissecting * Target aneurysm is at bifurcation * Target aneurysm will require coiling in addition to flow diversion, in Investigator's opinion