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Bracco Imaging S.p.A.
Maker of SonoVue®, an ultrasound contrast agent first launched in 2001. SonoVue® microbubbles are filled with sulfur hexafluoride (SF6) gas, and the membrane consists of phospholipids. In the U.S. the product is called Lumason, and it was approved by the FDA in 2014 for use in adults with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. In 2016, Lumason received FDA approval for its use in focal liver lesions in adult and pediatric patients. Lumason is supplied as a three-part kit. Each kit contains a vial of 25mg of lypid-type A lyophilized powder and 60.7 mg sulfur hexafluoride headspace, a prefilled syringe containing 5mL of Sodium Chloride 0.9% Injection, USP (Diluent), and a Mini-Spike.