CIO 2023-10 Final Results of the GPX Embolic Device Multi-Center Trial for Distal Applications

Purpose: GPX is a novel aqueous-based liquid embolic agent designed for use in durable and pre-operative transcatheter embolization procedures. 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.

Material and Methods: The trial was a prospective, multi-center, single-arm, open label, non-randomized feasibility study. Enrollment consisted of 17 subjects with diverse distal embolization needs in the peripheral vasculature. 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.

Results: The trial enrolled 17 patients in distal applications, including 7 renal angiomyolipomas, 4 renal cell carcinomas, 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 (immediately after delivery). Furthermore, the material exhibited good visibility during and after delivery with operators reporting excellent controllability during injection. At the 30-day follow-up, patients reported good outcomes, and sites remained fully occluded with stable positioning of the embolic device in each case where imaging was available.

Conclusions: The results of this FIH trial 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).