Fluidx Medical Technology has announced that the US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval to initiate the GPX embolic device pivotal clinical trial. The objective of this trial will be to evaluate the safety and effectiveness of the GPX embolic device.
Embolization is a minimally invasive catheter-based procedure that blocks blood flow to targeted blood vessels and organs, the recent press release explains. Over US$3.5 billion per year is spent on embolic devices to treat tumours, internal bleeding, aneurysms, fistula, uterine fibroids, prostates, malformations, neurovascular bleeding, and other conditions throughout the body, but these devices can be difficult to prepare and deliver.
“The GPX Embolic Device will fill a void in our toolbox,” said Michael Darcy (Washington University, St Louis, USA) and past president of the Society of Interventional Radiology (SIR). “Its simplicity, visibility, and distal reach will allow us to achieve deep tumour occlusion independent of delivery technique.”
As many as twenty medical centres across the USA, Canada, and New Zealand will participate in the study, which will begin enrolling shortly.
“This study will further expand on the positive results we saw in our recent multicentre clinical trial,” stated Libble Ginster, president and CEO of Fluidx Medical Technology. “Clinicians need more solutions to meet diverse patient needs.” The results of that trial were recently published in the Journal of Vascular and Interventional Radiology (JVIR). In that trial, the GPX embolic device achieved 100% technical success and high usability scores from physicians for ease of preparation, deliverability, and visibility.
