iVascular’s Amber Liquid Embolic Evaluated in Premarket OPAL Study

September 29, 2026—iVascular announced new phase 2 data from the OPAL study of Amber, the company’s liquid embolic. The findings were presented at CIRSE 2026, the annual meeting of Cardiovascular and Interventional Radiological Society of Europe in Copenhagen, Denmark.

Amber, which is not yet commercialized, is designed to have a clear CT visibility with minimum artifacts and ready to use, noted iVascular.

According to the company, OPAL is a prospective, multicenter, premarket study conducted in collaboration with 11 centers in Spain that are specialized in embolization.

The initiation of the OPAL first-in-human study was announced in November 2024 to evaluate the safety and efficacy of peripheral embolization with Amber in vascular anomalies, hemorrhages, aneurysms, pseudoaneurysms, type II endoleaks, varicose veins, portal veins, hypervascular tumors, and pathological organs.

The company noted that phase 1 of the OPAL study, which was focused on safety, delivered satisfactory results.

As reported in iVascular’s press release, the phase 2 results presented at CIRSE 2026 analyzed the safety and efficacy of Amber in 70 patients. The data included 98.6% total occlusion rate, demonstrating high immediate technical efficacy. Additionally, there was 0% microcatheter entrapment, material migration, and device-related fatal events.

The OPAL study is led by Principal Investigator Professor Fernando Gómez, MD, from Hospital La Fe in Valencia, Spain.

“Amber combines ease of use with encouraging efficacy and safety results,” commented Prof. Gómez in the press release. “The absence of any preparation requirements, together with zero microcatheter entrapments observed in the study, are particularly promising findings.”