iVascular announces the initiation of Opal, the first human study with the new embolic liquid Amber, based on a radiopaque biocompatible copolymer. OPAL is a prospective, single-arm, multi-center study with a sample size of 70 patients requiring peripheral embolization. It will be conducted in collaboration with 10 Spanish centers specialized in embolization and will be led by Dr. Fernando Gomez from Hospital La Fe (Valencia).
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.
The results of the study will provide crucial data on the safety and efficacy of Amber, as determined by the rate of complete vascular occlusion in all the evaluated indications. Patients will be followed up at discharge and at 1, 3 and 6 months after the intervention. Throughout the study, Dr. Gomez, together with the Clinical Events Committee (CEC) and the Data Safety Monitoring Board (DSMB), will ensure patient safety and the scientific integrity of the data obtained.
‘The OPAL study may be the first step towards changing the way embolisations with liquid are performed. 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,’ says Dr. Gómez.
The iVascular R&D Department assures that Amber has been designed to overcome the limitations of current embolic liquids. ‘Achieving total control of the product together with a homogeneous and intrinsic visualisation, being a ready to use liquid, have been the main objectives of Amber’s design’ says Sofía Valle (Project Leader).
With the initiation of the OPAL study, iVascular reaffirms its commitment to innovation and advancement in the treatment of vascular diseases in order to continue to provide advanced therapeutic solutions to improve the quality of life of patients worldwide.
