GE Healthcare Receives Approval for Its Own Manufacturing of Optison
November 22, 2013 – GE Healthcare announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to manufacture Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) in-house. Optison is a contrast agent that may improve the visualization of the left ventricular border ─ an area of the heart that is critical to see in order to assess and diagnose certain heart diseases. As a result of the FDA’s action, GE Healthcare will provide a supply of Optison to the U.S. and European markets from its manufacturing facility in Oslo, Norway, becoming the only contrast media manufacturer to supply its own stock to the United States.
“Adding our own manufacturing site for Optison has multiple benefits for physicians and patients, including an ability to increase capacity to meet market demands and help to ensure consistent supply to the contrast media market,” said Jan Makela, GM, Core Imaging, GE Healthcare Life Sciences.
“In part because of interrupted supply, ultrasound contrast media usage has yet to reach its full potential, so we are quite pleased that GE Healthcare has made this commitment and investment to independently manufacture Optison within its own facility,” said Benjamin F. Byrd, III, MD, FASE, President, American Society of Echocardiography. “Optison remains an important diagnostic option for patients who present with suboptimal echocardiograms. The Society believes that use of contrast in echocardiography studies can enhance the image and thus reduce the need for additional testing, helping to lower healthcare costs and provide better patient care.”
Optison is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve delineation of the left ventricular endocardial borders. Optison is not for use in patients with known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts or hypersensitivity to perflutren, blood, blood products, or albumin. It should not be administered by intra-arterial injection. As for all ultrasound contrast agents, Optison has a boxed warning indicating that serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration. Healthcare professionals should assess all patients for the presence of any condition that precludes Optison administration and always have resuscitation equipment and trained personnel readily available.
For more information: www3.gehealthcare.com/en