FDA Removes Shunt Contraindication From Lumason Label

Larry Hand

January 12, 2017

MONROE TOWNSHIP, NJ — Bracco Diagnostics has announced that the Food and Drug Administration has removed from the label of Lumason the contraindication that it should not be used in patients with known or suspected right-to-left, bidirectional, or transient right-to-left cardiac shunts[1].

The FDA posted the new label for Lumason (sulfur hexafluoride lipid-type A microspheres) on its website December 22, 2016.

The new label maintains a specific warning that some intravenously injected microspheres could bypass the filtering by the lung and enter the arterial circulation and that Lumason should not be administered by intra-arterial injection.

"The removal of this contraindication implies that the FDA has determined that the benefits from the diagnostic information that could be obtained through the use of Lumason in patients with cardiac shunts may outweigh the risk for systemic embolization," Dr Alberto Spinazzi (Global Medical and Regulatory Affairs, Bracco Group) stated in the release.

Lumason, an ultrasound contrast agent made up of gas-filled microspheres to enhance echogenicity of blood or urine, was initially approved by the FDA in 2014 for use in adults with suboptimal echocardiograms. Known globally as Sonavue, it gained additional approval in 2016 for use in ultrasonography of the liver in adult and pediatric patients and for use in the evaluation of suspected or known vesicoureteral reflux in pediatric patients.

The Centers for Medicare and Medicaid Services granted "pass-through" status in 2015 for reimbursement of Lumason in liver or abdominal ultrasound with contrast.

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