SIR 2024
Embolization
Rahmi Oklu, MD, PhD (he/him/his)
Professor
Mayo Clinic Arizona
Financial relationships: Full list of relationships is listed on the CME information page.
OBSIDIOTM Conformable Embolic (OCE) is a unique shear-thinning hydrogel embolic material. During delivery it conforms to the vessel and provides a rapid mechanical occlusion independent of patient coagulation status {1}. OCE received FDA 510k clearance in July 2022 for embolization of hypervascular tumors and for occlusion of blood flow to control bleeding/hemorrhaging in the peripheral vasculature {2}. Results from initial US cases, performed under a limited market evaluation (LME), are presented. The purpose of this evaluation was collecting early user experience, performance, and procedural data on use of OCE.
Materials and Methods:
The study included procedures performed between May and November 2023 at 27 sites within the United States. Following completion of each case, the operating physician was asked to complete a case survey reporting on vessel occlusion, procedure type, target vessel size, microcatheter information, conjunctive use of other embolic devices, and other procedural details. Technical success was tracked and defined as successful embolization of the target vasculature.
Results:
A total of 131 embolization procedures were performed with OCE, with technical success achieved in 100% (131/131) of cases. Embolization was performed in 35 gastrointestinal bleeds (GI) with the gastroduodenal artery (GDA) the most common target vessel (n=20). Other common target vessels were the renal (n=27), hepatic (n=11), and splenic (n=10) arteries. A total of 4 venous uses were recorded in varices (n=2) and gonadal veins (n=2). A total of 19 tumor embolizations were performed, including 9 renal angiomyolipomas, 2 primary renal cell carcinomas (RCCs), and 2 metastatic RCCs. Vessel diameter was ≤3 mm in 96 cases (73%), ≥3 mm in 16 cases (12%), and not recorded in 19 cases (15%). Microcatheter internal diameter (ID) was classified as 0.027 in 67% (n=88) and 0.021” in 25% (n=33) of deliveries. Other delivery devices used (n=8) included 4 F catheters, endoscopes, and balloon microcatheters. Obsidio was used in conjunction with other embolization devices in 33 procedures (25%), including coils in 25 (19%), plugs in 2 (2%), and particle-based embolics in 6 (5%).
Conclusion:
Initial experience with OCE demonstrated excellent technical success across a range of applications. Furthermore, the results of this study indicate that Obsidio can be used in conjunction with other embolization agents (e.g. coils) to produce successful embolization. A prospective, multicenter registry study is planned to examine safety and procedural outcomes.
PI-1769908-AA