Fluidx Medical’s Ultra Peripheral Embolic Platform in Development

November 30, 2023—Fluidx Medical Technology announced the development of the company’s Ultra peripheral embolic platform for addressing hemorrhage, tumor treatment, and other proximal embolization applications. The Ultra platform is designed to make catheter-based therapeutic embolization procedures safer, better, and faster, noted the press release.

According to the company, the Ultra platform is designed to treat patients requiring moderately distal to proximal embolization. Ultra does not require refrigeration, use toxic dimethyl sulfoxide, require special delivery catheters, need special mixers or preparation stations, or glue catheters into the body.

The development of the Ultra embolic platform comes after another large milestone for Fluidx Medical. The company’s flagship GPX embolic device is currently under investigational device exemption review with the FDA. The GPX, which completed a multicenter clinical trial as a multiuse embolic in 2023, focuses on embolization procedures where there is need for deep distal penetration.

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

“Embolic coils depend on the blood’s ability to clot and often require multiple coils to achieve complete occlusion,” commented Ryan O’Hara, MD, in the company’s press release. “Embolic particles are hard to visualize during delivery, increasing the risk of off-target embolization and leading to unintended harm of nearby tissues.” Dr. O’Hara, an interventional radiologist, is Medical Director at Comprehensive Integrated Care in Salt Lake City, Utah.

Danny Smith, Vice President of Research & Development at Fluidx Medical, stated in the press release, “We have seen a single delivery of Ultra block a targeted vessel region quickly in an area that would usually require several coils. Ultra is visible under x-ray, giving clinicians greater control and visualization of the embolic to ensure safe, accurate delivery.”