Fluidx Receives IDE Approval for Pivotal Trial of GPX Embolic Device

May 21, 2024—Fluidx Medical Technology, Inc. announced that the FDA has granted investigational device exemption (IDE) approval to initiate the GPX Embolic Device Pivotal Clinical Trial. The objective of the trial will be to evaluate the safety and effectiveness of the company’s GPX embolic device for tumor treatment.

According to the company, enrollment will begin shortly with up to 20 medical centers across the United States, Canada, and New Zealand participating in the study.

Michael Darcy, MD, Professor of Radiology at Washington University in St. Louis, Missouri, and past President of the Society of Interventional Radiology, commented on the technology in the Fluidx press release.

“The GPX embolic device will fill a void in our toolbox,” stated Dr. Darcy. “Its simplicity, visibility, and distal reach will allow us to achieve deep tumor occlusion independent of delivery technique.”

Libble Ginster, President and CEO of Fluidx Medical Technology, added, “This study will further expand on the positive results we saw in our recent multicenter clinical trial. Clinicians need more solutions to meet diverse patient needs.”

In that trial, the GPX embolic device achieved 100% technical success and high usability scores from physicians for ease of preparation, deliverability, and visibility. The results were recently published by Andrew Holden, MD, et al in the Journal of Vascular and Interventional Radiology.