Real-world clinical experience with Obsidio Conformable Embolic.

Abstract

Background: Obsidio Conformable Embolic (Obsidio) is a ready-made hydrogel with unique shear-thinning properties, used for occlusion of blood flow to control bleeding or hemorrhage in the peripheral vasculature and embolization of hypervascular tumors. While pre-clinical and clinical data have demonstrated successful embolizations using Obsidio, clinical experience overall is still limited, prompting a multi-institutional field assessment survey to collect additional data on the clinical utility and procedural details from a variety of Obsidio users. The field survey collected data from 131 embolization procedures performed using Obsidio between May and November 2023 at 27 institutions within the United States. Data collection included embolization site, vessel size, any adjunctive embolics used. The primary objective of the survey was to evaluate technical success, defined as complete embolization of the target vasculature immediately following the index procedure, as confirmed by angiography.

Results: Of the 131 embolization procedures performed, 69% (n = 90) were for hemorrhage control, 15% (n = 19) were for hypervascular tumors, and 17% (n = 22) were for other indications. Embolization of the gastroduodenal artery was the most common indication (n = 19/131; 15%). A single syringe (1 mL) or less of Obsidio was used for most cases (93%). In 33/131 cases (25%), Obsidio was combined with other embolization devices including coils (n = 25; 19%), particle-based embolics (n = 6; 4.6%), or plugs (n = 2; 1.5%). Technical success was achieved in 100% of Obsidio embolization cases (131/131 procedures).

Conclusion: Initial clinical experience demonstrated successful embolization of end-organ bleeds and hypervascular tumors utilizing Obsidio, thus making it an effective embolic agent alone or in conjunction with other embolic devices.