EMBOLISE: Embolization of the Middle Meningeal Artery with ONYXTM Liquid Embolic System (LES) In the Treatment of Subacute and Chronic Subdural Hematoma
The study is a prospective, multi-center, randomized, interventional, open label, controlled medical device clinical study, sponsored by Medtronic, evaluating the performance of the Onyx™ LES for MMA embolization for patients with symptomatic subacute or chronic subdural hematoma (SDH). The Onyx™ LES for embolization of MMA is investigational in the US. The objective of this Medtronic-sponsored study is to evaluate the safety and effectiveness of Onyx™ LES embolization of the middle meningeal artery (MMA) as adjunct to conventional treatment (surgery or observation) for symptomatic subacute or chronic subdural hematoma. Patients who are diagnosed with subacute and chronic subdural hematoma will be enrolled in this study.