Fluidx’s GPX Embolic Device Meets Primary Endpoints in Pivotal Trial

July 14, 2026—Fluidx Medical Technology, Inc. announced results from a pivotal clinical trial evaluating the company’s GPX embolic device.

In the United States, the device is being used in the trial under an FDA investigational device exemption (IDE). The company noted that findings from the study expand on results from the first-in-human study and support the premarket approval application to the FDA for commercial use in the United States.

Fluidx advised that GPX embolic device is not approved or available for commercial distribution in any country.

The data were presented in April at SIR 2026 and in May at GEST. The late-breaking abstract of the results was published in Journal of Vascular and Interventional Radiology.

According to the company, GPX achieved 100% success in delivery to the target vessel and 99.1% successful occlusion of flow, with 99.1% freedom from major adverse events.

Fluidx stated that the IDE clinical study was a single-arm, open-label, nonrandomized, prospective, multicenter study that enrolled 114 patients at 18 sites across the United States, Canada, and New Zealand. GPX was delivered through > 20 different microcatheter configurations with sizes from 1.9- to 2.8-F outer diameters and 110- to 165-cm lengths, demonstrating broad compatibility across a wide range of commonly used delivery devices.

Pathologies treated included prenephrectomy renal arteries, primary and metastatic bone tumors, renal cell carcinoma, hepatocellular carcinoma, renal angiomyolipoma, portal vein branches, and other vascular tumor or tumor metastases, noted the company.

The National Principal Investigator of the trial is Michael Darcy, MD, Professor of Radiology at Washington University in St. Louis, Missouri.

“These results are impressive and should help establish GPX as an important new tool in embolic therapy once approved,” commented Dr. Darcy in the Fluidx press release. “The physician survey results are promising. It shows that the device preparation, delivery, and behavior were easy to incorporate into existing practice norms.”