Fluidx Medical Technology, Inc. announced the completion of patient enrollment in theInvestigational Device Exemption (IDE) pivotal clinical trialevaluating the GPX Embolic Device. The prospective, multicenter, multinational study is designed to assess the safety and effectiveness of GPX for peripheral vascular embolization.
Vascular embolization is a minimally invasive, image-guidedprocedure that blocks blood flow to targeted vessels. Although more than $3.5 billion is spent annually on embolic devices to treat tumors and other conditions throughout the body, many of these devices remain difficult to prepare, deliver, and control.The GPX technology is packaged in a ready-to-use syringe, can be prepped tableside by the clinician in less than 30 seconds, and may be delivered through standard microcatheters without complex mixing systems or special delivery catheters.
“Completing enrollment is a critical milestone for the study, and we thank the investigators and patients who made it possible”,said Michael Darcy, MD, National Principal Investigator and Professor of Radiology at Washington University in St. Louis. “If the GPX trial can confirm the positive results of the earlier study published in 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.”
The trial enrolled one hundred and fourteen (114) patients at eighteen (18) sites across the United States, Canada, and New Zealand, involving more than forty (40) investigators. During the trial, GPX was delivered through over twenty (20) different microcatheter configurations, (spanning sizes from 1.9Fr(0.025”/0.63mm) to 2.8Fr (0.037”/0.93mm) outer diameters (OD) and lengths from 110 cm to 165 cm), demonstrating broad compatibility across a wide range of commonly used delivery devices.
Commenting on ease of use, Gary Siskin, MD, of Albany Medical Center, said, “We have been very pleased with our experience using GPX. Preparation was straightforward and truly ‘grab-and-go,’ which fits well into a busy clinical workflow and enables real time clinical decision making.”
“We are excited to analyze the data from this pivotal trial,” stated Libble Ginster, President and CEO of Fluidx Medical Technology, Inc. “Interventional oncology is a significant growth area. Liquid and gel embolics continue to have challenges around ease of use, requiring complex preparation and delivery techniques as well as complicated specialty delivery systems. The GPX technology has the potential to revolutionize the category.”