phenox Inc.
To determine safety and effectiveness of the p48 MW HPC and p64 MW HPC Flow Modulation Device in the treatment of wide-necked intracranial aneurysms.
To assess safety, effectiveness, and performance of the p48/p64 MW HPC Flow Modulation Device in the endovascular treatment of wide-necked intracranial aneurysms (IA) at 12 months post-procedure.
Inclusion Criteria: 1. Subject is ≥ 18 years 2. Subject has a mRS ≤2 before the index procedure 3. Subject has an unruptured or recanalized intracranial aneurysm (IA). The subject may also have a previous ruptured aneurysm, provided rupture of this aneurysm has occurred more than 30 days from the index procedure. The IA must have the following characteristics below: 1. Saccular or fusiform morphology 2. Located in the internal carotid artery and its branches 3. Aneurysm neck ≥4 mm or dome-to-neck ratio \<2 4. Parent vessel diameter ≥2.0mm and ≤5.0mm both distal and proximal to th…
The p48 MW HPC and p64 MW HPC Flow Modulation Device is indicated for use in the treatment of intracranial aneurysms (IAs) arising from a parent vessel with a diameter of ≥2.0mm and ≤5.0 mm.