Real-world clinical experience with Obsidio Conformable Embolic

Area of Science:

• Interventional Radiology
• Vascular Surgery
• Medical Devices

Background:

• Obsidio Conformable Embolic is a hydrogel with shear-thinning properties for vascular occlusion.
• It is used for hemorrhage control and embolization of hypervascular tumors.
• Clinical experience with Obsidio is limited, necessitating a field assessment survey.

Purpose of the Study:

• To collect data on the clinical utility and procedural details of Obsidio from multiple users.
• To evaluate the technical success of embolization procedures using Obsidio.

Main Methods:

• A multi-institutional field survey collected data from 131 embolization procedures using Obsidio.
• Procedures were performed between May and November 2023 across 27 US institutions.
• Data included embolization site, vessel size, and adjunctive embolic use. Technical success was defined as complete target vasculature embolization confirmed by angiography.

Main Results:

• 69% of procedures were for hemorrhage control, 15% for hypervascular tumors, and 17% for other indications.
• The gastroduodenal artery was the most common embolization site (15%).
• Obsidio was used alone in 75% of cases and combined with other devices in 25%. Technical success was 100% (131/131 procedures).

Conclusions:

• Obsidio Conformable Embolic demonstrated successful embolization for end-organ bleeds and hypervascular tumors.
• It is an effective embolic agent, usable independently or in combination with other devices.
• The study supports Obsidio's utility in clinical practice for embolization procedures.