New ultrasound contrast agent receives FDA approval

271

Bracco Diagnostics has announced that the FDA has approved its new ultrasound contrast agent Lumason (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, which is indicated for use in adults with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.

A press release states that Lumason, which is known as SonoVue in 39 countries, has an extensive and established safety profile and has been shown to convert suboptimal images into images of adequate diagnostic quality. The agent has been approved for use in adult patients with suboptimal echocardiograms, based on data submitted to the FDA from three multicentre controlled clinical trials showing significant improvement in image quality compared to unenhanced, native images and images enhanced with another ultrasound contrast agent approved by the FDA.


The press release adds that Lumason is supplied as a three-part kit. Each kit contains a Lumason vial containing 25 mg of lipid-type A lyophilised powder and 60.7mg sulfur hexafluoride headspace, a prefilled syringe containing 5mL of Sodium Chloride 0.9% Injection, USP (Diluent) and a Mini-Spike.


“The approval of Lumason offers an option to physicians and sonographers who are unable to obtain optimal quality echocardiograms due to patient habitus or clinical status,” said Alberto Spinazzi, head of Global Medical and Regulatory Affairs at Bracco.