Clinical studies
Explore studies evaluating safety and performance outcomes of Obsidio Embolic.
OCCLUDE Registry
Overview - A Prospective, Post-Approval, Open-Label, Multi-Center United States (US) Registry to Evaluate the Effectiveness and Safety of Obsidio Embolic in Clinical Practice.
Objective - Assess effectiveness and safety outcomes of patients with Obsidio Embolic in a real-world setting.
Results - Obsidio Embolic achieved 100% technical success, 100% clinical success, and a low rate of major adverse events (MAEs), demonstrating safe and effective embolization. The full dataset is scheduled to be published in 2026, pending journal review, and will include details on effectiveness, safety, patient population, target vasculature and more.
Obsidio Embolic Limited Market Evaluation (LME) report
Background – Obsidio received 510(k) clearance in July 2022 and Boston Scientific acquired Obsidio (formerly GEM/Gel Embolic Material) from Obsidio, Inc. in August 2022. Boston Scientific chose to launch Obsidio Embolic in the US through a limited market evaluation (LME) to obtain early user experience prior to moving into a full commercial launch.
Methods – 27 sites in the US were chosen for the LME. Post completion of each case, the commercial representatives were tasked with completion of a case report survey.
Technical Success – Technical success for a Obsidio Embolic case was defined as successful embolization of the target vasculature. In the LME, Obsidio Embolic was able to achieve embolization target in all cases and had a success rate of 100% (131/131 cases).
Obsidio first-in-human clinical study: evaluation of Obsidio Embolic safety and performance
Overview – A single-center study* sought to evaluate the safety and performance of Obsidio Conformable Embolic (OCE) in patients requiring vascular embolization for hypervascular renal tumors.
Objectives – The study sought to demonstrate that Obsidio Embolic could be delivered safely, occludes the artery where deposited without migration, and does not lead to a change in standard blood tests.
Results – Obsidio Embolic achieved the absence of flow in the blood vessels of tumors, with embolization demonstrated to be durable without migration at Day 7.
* Obsidio Conformable Embolic performance testing
Single-center experiences
Procedures across multiple studies support broad clinical utility, showing consistently high technical success and reliable performance across a wide range of indications.
MD Anderson – A Single-Center Experience with a Shear-Thinning Conformable Embolic
Recently published in JVIR, the retrospective study evaluated outcomes after embolization using Obsidio Embolic and demonstrated a treatment effectiveness rate of 100%.
University of Chicago – A Novel Conformable Embolic for Selective Transarterial Embolization of Acute Hemorrhages: A Technical Note
A single center’s early experience in using Obsidio Embolic for treating acute intra-abdominal hemorrhage in three patients highlights safety, technique, and effectiveness. In all cases, Obsidio Embolic completely occluded the target vessel.
Rutgers University – A Single Institution Experience with a Shear-Thinning Conformable Embolic for Endovascular Embolization
A 21-patient study assessing the safety and feasibility of Obsidio Embolic for treatment in peripheral hemorrhage, preoperative tumors, and precryoablation tumors reported 100% technical success.
University of North Carolina – Early Experience Using Tantalum-Loaded Nanocomposite Hydrogel Conformable Embolic for Upper Gastrointestinal Bleeding: Open-Sandwich Technique
This study reported results from 10 consecutive gastroduodenal artery embolization (GDA) procedures performed using Obsidio Embolic and demonstrated 100% technical success.
University of North Carolina – Technical and Clinical Outcomes of Embolization of Hypervascular Renal Tumors Using Tantalum-Loaded Obsidio Conformable Embolic (Ta-OCE): a single-center experience
Embolization of hypervascular renal tumors with Obsidio Embolic demonstrated 100% technical success and a significant reduction in tumor diameter in a 10-patient study.
