New Phase II data from the OPAL study, evaluating iVascular’s novel liquid embolic Amber ahead of its market launch, were presented at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual congress (5–9 September, Copenhagen, Denmark).
OPAL is a prospective, multicentre, pre-market study designed to evaluate Amber, conducted in collaboration with 11 Spanish centres that specialise in embolization. The study is led by principal investigator Fernando Gómez (Hospital La Fe, 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 analyses the safety and efficacy of Amber in 70 patients.
Among headline findings, the investigators demonstrated a 98.6% total occlusion rate, demonstrating high immediate technical efficacy. A 0% rate of microcatheter entrapment and material migration was also shown, as well as no device-related fatal events.
According to the company, 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 no microcatheter entrapment and 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 Gómez.
