FDA approves label changes for GE’s Optison

October 3, 2016 By Sarah Faulkner Leave a Comment

GE Healthcare (NYSE:GE) announced today that the FDA approved label changes for its ultrasound contrast agent Optison, removing contraindications for use in patients with cardiac shunts and for administration by intra-arterial injection.

Optison is the 1^st contrast agent available in the U.S. to receive this label change, according to GE.

“Up to one-third of our patients have known or suspected cardiac shunts and, thanks to this important FDA decision, they too will now have access to ultrasound contrast agents, which offer an inexpensive and radiation-free option for diagnostic imaging,” International Contrast Ultrasound Society co-prez Dr. Steven Feinstein said in prepared remarks. “The International Contrast Ultrasound Society applauds the FDA for its decision, and believes it will benefit individual patients as well as our healthcare delivery system,”

Previously, to determine if a patient was contraindicated to receive an ultrasound contrast agent, doctors used an agitated saline procedure to see if the blood flow pattern in the heart was characteristic of a cardiac shunt.

“We welcome this FDA decision and hope that this will allow more patients access to contrast-enhanced ultrasound procedures and improve the management of their conditions,” chief technology officer Ger Brophy added.

“We are extremely pleased that the FDA has changed the labeling for cardiac shunts with Optison when it is used in the clinically important group of patients who have suboptimal echocardiograms, and a need for left ventricular opacification and delineation of LV borders. Many of these patients have limited options for cardiac imaging, and the FDA’s decision will facilitate their care,” head of global medical services Mark Hibberd explained.

GE’s stock was trading at $29.65 apiece in afternoon trading activity, up 0.1%.

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