Fluidx Impass Catheter-Directed Embolic Device Being Developed for Neurovascular Use

January 10, 2023—Fluidx Medical Technology, Inc. announced findings from in vivo research of the company’s Impass embolic device for middle meningeal artery (MMA) embolization to treat chronic subdural hematomas (CSDH) on the surface of the brain. The technology is in development.

Image showing the distal filling of the Impass embolic device.

The Impass embolic device is part of the portfolio of embolics currently under development by Fluidx. In Fall 2022, Fluidx announced the completion of a multicenter clinical trial with the GPX embolic device to treat a broad range of peripheral applications including tumor devascularization.

According to the company, catheter-based MMA embolization with Impass can be an alternative to surgical treatment of CSDH, which typically involves drilling a hole in the skull and draining the blood.

During the embolization procedure, a small catheter is navigated into the MMA located within the dura mater that covers the brain; then, an embolic material is delivered into the vessel to block arterial flow. MMA embolization is particularly appealing for elderly patients and others who cannot undergo invasive surgical procedures, noted Fluidx.

Similar to the company’s GPX embolic device, the Impass embolic device uses core Fluidx embolic technology but is designed specifically for neurovascular uses. The material is a low-viscosity, aqueous-based solution that solidifies into a durable embolus upon delivery without polymerization or dimethyl-sulfoxide precipitation.

The GPX and Impass embolic devices are under development and do not have marketing clearance or approval in any market. The devices are described and shown for research, educational, and engineering use only, advised the company.