Results and data on vascular embolic device GPX (Fluidx Medical Technology), a new proprietary in situ setting embolic agent that combines the benefits of coils, gel-beads, and other embolics, were presented at the 2018 Society of Interventional Radiology conference (17-22 March, Los Angeles, USA).
“GPX is a biocompatible particle embolic loaded in a pre-packaged syringe in a low-viscosity state. After injection into a blood vessel through a standard catheter, GPX can fill the targeted vessel and therapeutically slow or stop blood flow,” said Josh Jones, presenting author of the scientific abstract. “It is non-toxic and non-inflammatory and can be delivered through standard off-the-shelf small and large catheters. It does not rely on polymerisation or precipitation, and is designed to deliver precise control and safety for embolisation procedures.”
Therapeutic catheter-delivered embolisation is performed to stop or slow arterial or venous blood flow into certain organs or anomalies to control bleeding, treat aneurysms, seal arterial venous malformations, selectively block blood flow into specific organs and conditions (prostate, uterine fibroids…etc.), and/or to de-vascularise certain tumors to starve them of blood supply.
“The data presented today is exciting. In acute in-vivo experiments, GPX was delivered with no catheter reflux and demonstrated complete vascular occlusion without crossing into the venous circulation,” said David Blossom, president of Fluidx Medical Technology. “Some other embolic devices stick to catheters during delivery which can create patient safety issues. Today’s data shows that a catheter could be left in the body, with GPX embolic material around it, for hours without risk of catheter entrapment. Because of its ease-of-use and precise control, GPX represents a promising new device to help patients in a variety of embolisation scenarios.”
Two scientific abstracts on the device were also presented earlier this year at Leipzig Interventional Course (LINC; 31 January-2 February, Leipzig, Germany).
Embolic devices include particles, coils, and liquids or glues. Particles, sometimes referred to as “beads” or “gel-beads”, are generally small polymer spheres injected thorough catheters which flow downstream with the blood flow and embolise large spaces. However, particles are hard to control, sometimes uncontrollably and unintentionally flow into non-target organs. They also typically are not radiopaque, and do not allow the clinician to create a plug.
Metallic coils can create a plug to occlude flow, but lack precision, sometimes perforating the vessel, and often require numerous expensive deployments to occlude. Liquid embolics, including “glues”, have advantages for certain procedures, but are associated with cytotoxicity, vascular inflammation, clumping, in-vivo polymerisation and precipitation, and accidental catheter entrapment in the body that can be catastrophic for the patient.
GPX is currently under development and not FDA cleared at this time.