Arsenal Medical Receives FDA IDE Approval for the RADIANT Pivotal Trial of NeoCast™ in Chronic Subdural Hematoma
A randomized, controlled study of a novel liquid embolic, NeoCast, adjunctive to surgery
Excerpt from the Press Release:
WALTHAM, Mass.–(BUSINESS WIRE)–Arsenal Medical, a clinical-stage company developing innovative biomaterial-based devices, announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval for RADIANT, a pivotal trial evaluating NeoCast™. NeoCast is a novel liquid embolic under development that is designed to achieve pain-free, predictable distal penetration of the middle meningeal artery (MMA).
RADIANT is a prospective, randomized, multicenter study for the treatment of symptomatic subacute and chronic subdural hematoma (cSDH) adjunctively with surgery. The trial will compare NeoCast to Onyx LES, an FDA-approved embolic agent. This will be the first FDA-approved head-to-head study of two liquid embolic agents for cSDH. Approximately 360 subjects will be enrolled in a 2:1 randomization across up to 35 sites in the United States and Australia.
“Chronic subdural hematoma is becoming one of the most common conditions we manage in neurointervention,” said Charles Matouk, MD, Neurosurgeon at Yale New Haven Hospital and co-principal investigator of the RADIANT trial. “RADIANT will evaluate NeoCast as a potentially differentiated liquid embolic designed to provide predictable distal penetration while minimizing patient discomfort.”
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