Fluidx Medical Technology has announced the positive results from the investigational device exemption (IDE) pivotal clinical trial evaluating the GPX embolic device.
In the 114 patients that were treated in the trial, GPX achieved 100% success in delivery to the target vessel and 99.1% successful occlusion of flow, with 99.1% freedom from major adverse events.
In a recent press release the company details that the GPX embolic device is an embolic technology that enables controlled, deep and durable embolization ideal for many applications, including oncology.
The IDE clinical study was a single-arm, open label, non-randomised, prospective, multicentre study and enrolled one hundred and fourteen patients at eighteen sites across the USA, Canada, and New Zealand, involving more than forty investigators. During the trial, GPX was delivered through over twenty different microcatheter configurations, (spanning sizes from 1.9Fr (0.025”/0.63mm) to 2.8Fr (0.037”/0.93mm) outer diameters and lengths from 110cm to 165cm.
“These results are impressive and should help establish GPX as an important new tool in embolic therapy once approved”, said Michael Darcy, national principal investigator and professor of radiology at Washington University in St. Louis, USA. “The physician survey results are promising. It shows that the device preparation, delivery, and behaviour were easy to incorporate into existing practice norms.”
Pathologies treated included pre-nephrectomy renal arteries, primary and metastatic bone tumours, renal cell carcinoma, hepatocellular carcinoma, renal angiomyolipoma, portal vein branches, and other vascular tumour or tumour metastases.
“We are excited about this data,” stated Libble Ginster, president and chief executive officer of Fluidx Medical Technology. “The feedback has been overwhelmingly positive, and this is a major milestone for Fluidx. The GPX technology has the potential to revolutionise the interventional oncology category.”
The Fluidx GPX embolic device is not approved or available for commercial distribution in any country. In the USA, the device is being used under an IDE from the US Food and Drug Administration (FDA). The company states that findings from the IDE study expand on results from the first-in-human study and support the premarket approval (PMA) application to the FDA for commercial use in the USA.
