Fluidx Medical Introduces New Ultra Embolic Platform

Fluidx Medical, a medtech company focused on embolic technologies, recently announced its new Ultra embolic platform designed to make therapeutic embolization a safer, better, and faster procedure.

Embolization is minimally invasive and catheter based. The procedure blocks blood flow to targeted blood vessels and organs to treat internal bleeding, aneurysms, fistula, uterine fibroids, tumors, prostates, malformations, and other conditions throughout the body. In all, over $3.5 billion is spent per year on embolic particles, metal coils, and liquid to solid devices for these purposes.

The Ultra platform, according to the company, is designed to address gaps in patient need in relation to moderately distal to proximal embolization. The device does not require refrigeration — a departure from many current treatment equivalents — does not use toxic dimethyl sulfoxide, or require special delivery catheters, need special mixers or preparation stations, or glue catheters into the body.

"We have seen a single delivery of Ultra block a targeted vessel region quickly in an area that would usually require several coils," said Danny Smith, vice president of research & development at Fluidx.  "Ultra is visible under x-ray giving clinicians greater control and visualization of the embolic to ensure safe, accurate delivery."

The introduction of the Ultra platform follows another milestone for Fluidx, as its GPX Embolic device is currently under FDA Investigational Device Exemption (IDE) review. The GPX device targets embolization procedures with a need for deep distal penetration and successfully completed a multi-center clinical trial as a multi-use embolic in 2023.

Of note, neither the Ultra or GXP devices have been approved or cleared by FDA, or any other market at this time.