OCCLUDE Registry Overview
Objective – Assess effectiveness and safety outcomes of patients who undergo embolization with Obsidio Conformable Embolic.
Planned number of site/subjects – Up to 125 patients, 23 sites in US.
Follow-up schedule – Pre-procedure, Index Procedure, discharge, 7-Day and 1-Month follow up visit (phone or in-office).
Interim Analysis (IA) – IA planned after 60 patients have completed follow up.
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.
