Fluidx GPX Embolic Device Pivotal Trial Completes Enrollment

January 8, 2026

January 7, 2026—Fluidx Medical Technology, Inc. announced the completion of patient enrollment in the investigational device exemption (IDE) pivotal clinical trial evaluating the company’s GPX embolic device. Commencement of the GPX trial was announced in November 2024.

According to the company, the prospective, multicenter, multinational study is designed to assess the safety and effectiveness of GPX for peripheral vascular embolization. More than 40 investigators enrolled 114 patients at 18 sites across the United States, Canada, and New Zealand.

In the trial, GPX was delivered through more than 20 different microcatheter configurations—sizes from 1.9 to 2.8 F (outer diameters) and lengths from 110 to 165 cm—demonstrating broad compatibility across a wide range of commonly used delivery devices, noted the company.

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

“Completing enrollment is a critical milestone for the study, and we thank the investigators and patients who made it possible,” commented Dr. Darcy in the Fluidx press release. “If the GPX trial can confirm the positive results of the earlier study published in Journal of Vascular and Interventional Radiology (JVIR), it could help establish GPX as an important new tool in embolic therapy. We look forward to sharing this data with the interventional community.”

In the May 2024 announcement of IDE approval for the pivotal trial, Fluidx noted that the first-in-human trial results published that were by Andrew Holden, MD et al in JVIR showed that the GPX embolic device achieved 100% technical success and high usability scores from physicians for ease of preparation, deliverability, and visibility (2024;35:232-240).