Arsenal Medical has announced that the US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval for RADIANT—a pivotal trial evaluating the company’s novel NeoCast liquid embolic agent, which has been designed to achieve pain-free, predictable distal penetration of the middle meningeal artery (MMA).
RADIANT is a prospective, randomised, multicentre study assessing symptomatic subacute and chronic subdural haematoma (cSDH) patients treated adjunctively with surgery. The trial will compare NeoCast to the US FDA-approved Onyx liquid embolic system (Medtronic).
According to Arsenal, this will be the first US FDA-approved head-to-head study of two liquid embolic agents for cSDH. Approximately 360 subjects will be enrolled and randomised 2:1 across up to 35 sites in the USA and Australia.
“CSDH is becoming one of the most common conditions we manage in neurointervention,” said Charles Matouk (Yale New Haven Hospital, New Haven, USA), co-principal investigator for the RADIANT trial. “RADIANT will evaluate NeoCast as a potentially differentiated liquid embolic designed to provide predictable distal penetration while minimising patient discomfort.”
“FDA approval of our IDE is a major step in our effort to demonstrate that NeoCast can offer an innovative embolic to neurointerventionalists,” added Upma Sharma, chief executive officer (CEO) of Arsenal. “As MMA embolisation gains momentum, many physicians still rely upon legacy materials that can be difficult to use, and that contain adhesives or harsh solvents. NeoCast is designed to be simple to use and well tolerated by patients. We are excited to get the RADIANT trial underway.”
