Fluidx Medical Technology has announced completion of patient enrolment in the investigational device exemption (IDE) pivotal clinical trial evaluating the GPX embolic device. The prospective, multicentre, multinational study is designed to assess the safety and effectiveness of GPX for peripheral vascular embolization.
A company press release notes that 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 enrolment is a critical milestone for the study, and we thank the investigators and patients who made it possible”, said Michael Darcy (Washington University, St Louis, USA), national principal investigator. “If the GPX trial can confirm the positive results of the earlier study published in JVIR [Journal of Vascular and Interventional Radiology], 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 114 patients at 18 sites across the USA, Canada, and New Zealand, involving more than 40 investigators. During the trial, GPX was delivered through over 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 110–165 cm), demonstrating broad compatibility across a wide range of commonly used delivery devices.
Commenting on ease of use, Gary Siskin (Albany Medical Center, Albany, USA) 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 analyse the data from this pivotal trial,” stated Libble Ginster, president and chief executive officer (CEO) of Fluidx Medical Technology. “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 revolutionise the category.”
Fluidx Medical Technology advises that the GPX embolic device is under development and is intended for research, educational, and engineering use only. It has not received marketing clearance or approval in any market.
