iVascular Initiates OPAL FIH Study of Amber Embolic Liquid

November 11, 2024—iVascular announced the initiation of OPAL, a first-in-human study of Amber, the company’s embolic liquid based on a radiopaque biocompatible copolymer.

According to iVascular, OPAL is a prospective, single-arm, multicenter study that will enroll 70 patients requiring peripheral embolization. It will be conducted in collaboration with 10 Spanish centers specialized in embolization. The study will be led by Fernando Gomez, MD, from Hospital La Fe in Valencia, Spain.

The company stated that the main objective of the OPAL study is to evaluate the safety and efficacy of Amber in vascular anomalies, hemorrhages, aneurysms, pseudoaneurysms, type II endoleaks, varicose veins, portal veins, hypervascular tumors, and pathological organs.

Safety and efficacy will be determined by the rate of complete vascular occlusion in all the evaluated indications. Patient follow-up will be conducted at discharge and at 1, 3, and 6 months after the intervention.

“The OPAL study may be the first step towards changing the way embolizations with liquid are performed,” commented Dr. Gomez in iVascular’s press release. “All of us who have been able to test Amber agree that beyond its excellent properties in terms of penetration and visualization, it will increase safety in this type of treatment.”