Axium™ MicroFX™ for Endovascular Repair of IntraCranial Aneurysm-A Multicenter Study

Axium™ MicroFX™ for Endovascular Repair of IntraCranial Aneurysm-A Multicenter Study

This is a multicenter, prospective single-arm trial evaluating the safety and efficacy of the Axium MicroFX coil system in 100 aneurysms.

This is a multicenter, prospective single-arm trial evaluating the safety and efficacy of the Axium MicroFX coil system in 99 patients at 13 study centers. The primary endpoint of the trial was the anatomic occlusion of the aneurysm in the immediate post-procedure angiogram basedon the Raymond classification. Secondary endpoints included safety during the procedure, safety after the procedure, detachment system performance, stability of the embolization, and packing efficacy.

Inclusion Criteria:

• Confirmed diagnosis of one or more intracranial aneurysm, either ruptured or unruptured.
• Information on data collection provided to the patient or legally authorized representative and signed informed consent.
• Aneurysm diameter ≤10mm .
• Age range of 18 - 90.

Exclusion Criteria:

• Aneurysm previously treated.
• Aneurysm AVM related or dissecting.
• Participation in a clinical investigation of other aneurysm treating or related devices.
• Any condition that would preclude the conduct of protocol follow-up.
• Aneurysm anatomy that is determined inappropriate for Axium coil placement, prior to opening of an Axium coil.