This is a prospective, randomized, controlled, open-label, blinded endpoint (PROBE) clinical investigation in which patients with non-emergent chronic subdural hematoma (cSDH) requiring treatment will be randomized (1:1) to either initial surgical evacuation (Control Arm) or initial MMAE with PHIL™ (investigational arm).
Age 22 years or older
Diagnosis of chronic subdural hematoma
Subject, or their legally authorized representative provides a signed and dated Informed Consent Form
Pre-morbid mRS 0-1
Prior ipsilateral craniotomy or burr hole evacuation of cSDH
Prior embolization of either MMA
Requires (in the opinion of the treating surgeon) full or mini-craniotomy at time of randomization
Emergent subdural hematoma evacuation needed
Microvention-Terumo, Inc.
Lead sponsor