Fluidx says GPX embolic device hit primary endpoints in pivotal IDE trial

Fluidx Medical Technology said its GPX Embolic Device met primary endpoints in a 114-patient pivotal IDE trial, with 100% delivery success and 99.1% flow occlusion. The results, presented at SIR and GEST and published in JVIR, support the company’s FDA premarket approval filing.

Why it matters: - GPX could broaden options for embolization procedures in oncology and other vascular treatments if the FDA approves commercial use. - The device’s strong delivery and occlusion results may help address a market where embolic devices can be hard to prepare, deliver and control. - Fluidx said the findings support its Premarket Approval application to the FDA.

What happened: - Fluidx Medical Technology announced positive results from an Investigational Device Exemption pivotal clinical trial of the GPX Embolic Device. - The trial treated 114 patients and met its primary endpoints. - GPX achieved 100% successful delivery to the target vessel. - GPX achieved 99.1% successful occlusion of flow. - GPX posted 99.1% freedom from major adverse events. - The data was presented at the Society of Interventional Radiology annual meeting and the Global Embolization Symposium and Technologies annual meeting. - The GPX abstract received a BEST of GEST award. - The late-breaking abstract was published in the Journal of Vascular and Interventional Radiology.

The details: - The study was single-arm, open-label, non-randomized, prospective and multi-center. - Investigators enrolled patients at 18 sites across the United States, Canada and New Zealand. - More than 40 investigators participated in the trial. - GPX was delivered through more than 20 microcatheter configurations during the study. - Those catheters ranged from 1.9Fr to 2.8Fr in outer diameter and from 110 cm to 165 cm in length. - Fluidx said the compatibility data showed the device worked across a wide range of commonly used delivery devices. - Treated pathologies included pre-nephrectomy renal arteries, primary and metastatic bone tumors, renal cell carcinoma, hepatocellular carcinoma, renal angiomyolipoma, portal vein branches and other vascular tumor or tumor metastases. - GPX is packaged in a ready-to-use syringe and can be prepped tableside in less than 20 seconds. - The device can be delivered through standard microcatheters without complex mixing systems or special delivery catheters.

Between the lines: - The trial data is aimed at showing GPX is easier to use than some existing embolic products, a key selling point in interventional radiology. - The physician feedback cited by Fluidx suggests the device fits current practice patterns, which could matter for adoption if the FDA clears it. - The study builds on first-in-human results and gives Fluidx a stronger evidence base for commercialization. - Michael Darcy, the trial’s national principal investigator, said the results should help establish GPX as an important new tool once approved. - Libble Ginster, Fluidx’s president and CEO, called the trial a major milestone and said the technology could reshape interventional oncology.

What's next: - Fluidx plans to use the IDE findings to support its PMA submission to the FDA for U.S. commercial approval. - GPX remains unavailable for commercial distribution in any country. - In the U.S., the device is still being used only under an FDA IDE. - Fluidx said the broader portfolio includes GPX, ULTRA and IMPASS, all aimed at easy-to-use, controllable embolic gels.

The bottom line: - Fluidx now has pivotal trial data that points to strong deliverability, high occlusion rates and low major adverse events, all of which strengthen the case for FDA approval.