GE Healthcare has received approval from the U.S. Food and Drug Administration (FDA) for a label change for its Optison ultrasound contrast agent.
The FDA removed the contraindications for use in patients with cardiac shunts and for administration by intra-arterial injection. A cardiac shunt is a pattern of blood flow in the heart that deviates from the normal flow of the circulatory system.
With suspected cardiac shunt populations, an agitated saline procedure previously was needed to determine if a shunt existed and whether the patient was contraindicated to receive an ultrasound contrast agent.
