Phase II efficacy data in 70 patients show a 98.6% total occlusion rate, with 0% microcatheter entrapment, 0% material migration and no-device-related events identified.
Barcelona, September 3, 2026. New Phase II data from the OPAL study, evaluating iVascular’s novel liquid embolic Amber ahead of its market launch, were presented at CIRSE 2026 (Cardiovascular and Interventional Radiological Society of Europe) in Copenhagen, Denmark.
OPAL is a prospective, multicenter, pre-market study designed to evaluate Amber, iVascular’s new embolic liquid. The study is being conducted in collaboration with 11 Spanish centers specialized in embolization and is led by Principal Investigator Prof. Fernando Gómez, MD, from Hospital La Fe in Valencia, Spain.
The study is structured in two phases. Phase I, focused on safety, delivered very satisfactory results. The results presented at CIRSE 2026 correspond to Phase II, which analyzes the safety and efficacy of Amber in 70 patients.
The Phase II results are as follows:
- 98.6% total occlusion rate, demonstrating high immediate technical efficacy
- 0% microcatheter entrapment
- 0% material migration
- 0% device-related fatal Events
These findings highlight Amber’s ease of use, combined with encouraging efficacy and safety outcomes. In particular, the fact that the embolic liquid requires no preparation and was associated with 0% microcatheter entrapment and 0% material migration in the study represents a particularly promising result. “Amber combines ease of use with encouraging efficacy and safety results. The absence of any preparation requirements, together with zero microcatheter entrapments observed in the study, are particularly promising findings”, said Prof. Gómez.
About Amber Amber is iVascular’s new embolic liquid, not yet commercialized, designed to have a clear CT visibility with minimum artifacts and ready to use. It has a versatile formulation and a non-adhesive behavior.
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