Andrew Holden, ONZM, MBChB, FRANZCR, EBIR
Aukland District Health Board / Auckland Hospital
Disclosure(s): Boston Scientific: Advisory Committee or Review Panel Member (Ongoing); Gore: Advisory Committee or Review Panel Member (Ongoing); Medtronic: Advisory Committee or Review Panel Member (Ongoing); Philips: Advisory Committee or Review Panel Member (Ongoing)
A prospective, multicenter first-in-human (FIH) clinical trial has been completed examining the use of GPX Embolic Device in distal applications within the peripheral vasculature. The primary objectives of this study were to evaluate safety and early indicators of performance for the GPX Embolic Device. GPX is a novel liquid embolic agent designed for use in durable and pre-operative transcatheter embolization procedures. Upon exiting the catheter, it forms an electrostatic gel in response to physiological ionic strength. The material follows vascular flow and is designed for deep distal penetration of distally-flowing vessels and complex vessel beds. Here, final results of this FIH trial are presented.
Materials and Methods:
The trial was a prospective, multi-center, single-arm, open label, non-randomized, prospective feasibility study evaluating the use of the device in the peripheral vasculature. Enrollment consisted of 17 subjects with diverse distal embolization needs. Technical success, freedom from adverse events, and handling/performance characteristics were assessed. Follow-up was performed at 30 days, with imaging included if dictated by standard of care.
The trail enrolled 17 patients in distal penetration applications, including 7 renal angiomyolipomas, 4 renal cell carcinomas (primary and secondary), 4 portal vein embolizations, a pelvic tumor, and a polycystic kidney. In all cases, technical success was achieved with target regions fully occluded at the first angiogram (taken immediately after delivery) and excellent distal penetration into vessel beds. Furthermore, the material exhibited good visibility during and after delivery with operators reporting excellent controllability during injection. The only adverse events that occurred within these cases were instances of post embolization syndrome, all of which resolved within a few days. At the 30-day follow-up, patients reported good outcomes, and sites remained fully occluded with stable positioning of the embolic device confirmed in cases where imaging was available.
The results of this FIH trail demonstrate that the GPX Embolic Device may provide safe and effective embolization for arterial or venous applications where deep distal penetration is desired. In the study, these cases have resulted in excellent outcomes, including clinical success (e.g. resolution of hematuria in some cases), durable occlusions (no instances of recanalization or migration), good radiographic visibility, and favorable handling characteristics (e.g. control during delivery, visibility).