The FDA has approved a label change that allows GE Healthcare's Optison ultrasound contrast agent to be used in a larger range of cases. Specifically, it downgrades its use in patients with cardiac shunts and for administration by intra-arterial injection from a contraindication to a warning and precaution.
Prior to this labeling shift, to use the agent, perflutren protein-Type A microspheres injectable suspension
, in suspected cardiac shunt populations, an agitated saline procedure was needed first.
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The change makes Optison the first contrast agent for use in the U.S. to be so labelled, GE said in a statement.
The change has brought positive responses from a number of health care professionals, including Dr. Sharon L. Mulvagh, who is professor of medicine, director of the Women's Heart Clinic and preventive cardiology consultant in cardiovascular diseases at the Mayo Clinic and Mayo Clinic College of Medicine, GE noted.
“This label change will allow more patients access to a diagnostic imaging tool that has established safety and efficacy. The FDA’s decision to remove this contraindication is supported by a body of data from studies demonstrating safety and clinical benefits of all ultrasound contrast agents in patients with cardiovascular diseases,” said Mulvagh.
Mulvagh called the label change “an important step forward in eliminating barriers to ultrasound contrast use and delivering quality diagnostic care of value to our patients.”
Cardiac shunts are quite common and pose a challenge to clinicians. “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,” noted Dr. Steven Feinstein, co-president of the International Contrast Ultrasound Society.
The decision came about thanks to “the overwhelming weight of evidence from clinical trials," noted Dr. Jonathan Lindner, M. Lowell Edwards Professor of Cardiology at the Knight Cardiovascular Center, Oregon Health & Science University.
He added that “most practitioners in the field of echocardiography already realize the benefits of using contrast agents and understand their capacity to improve diagnostic accuracy, improve outcomes, and streamline care. However, a major obstacle to widespread use has been lack of consensus and confusion regarding how far one needs to go to exclude shunts, no matter how small.”
The clinical advantage of appropriate use of the contrast agent was highlighted by the Head of Global Medical Services at GE Healthcare, Mark Hibberd, who added that Optison use will expand the imaging options and facilitate the care of “the clinically important group of patients who have suboptimal echocardiograms, and a need for left ventricular opacification and delineation of LV borders.”
The contrast market is set to surpass $6 billion by 2022, according to GlobalData research announced in April
. The market was “just over $4.3 billion in 2015,” giving a compound annual growth rate of 4.9 percent.