News | November 22, 2013

GE Healthcare Receives Approval for Its Own Manufacturing of Optison

Optison Remains an Important Diagnostic Option for Patients With Suboptimal Echocardiograms

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

Related Content

Houston Methodist Hospital Enters Multi-Year Technology and Research Agreement With Siemens Healthineers
News | Cardiac Imaging| August 17, 2017
Houston Methodist Hospital and Siemens Healthineers have entered into a multi-year agreement to bring cutting-edge...
ISMRM Issues Guidelines for MRI Gadolinium Contrast Agents
News | Magnetic Resonance Imaging (MRI)| August 15, 2017
The International Society for Magnetic Resonance in Medicine (ISMRM) has provided new guidance in the use of contrast...
Clarius Wireless Ultrasound Scanners Now Available With Advanced Features
News | Ultrasound Imaging| August 09, 2017
Clarius Mobile Health has released advanced features and options for its wireless handheld ultrasound scanner for...
Oregon Tech Partners with Mindray for High-Tech Ultrasound Education
News | Ultrasound Imaging| August 04, 2017
To better prepare its ultrasound students to compete and thrive in the evolving healthcare environment, Oregon...
Carestream Shows Touch Prime Systems at Society for Vascular Ultrasound Conference
News | Cardiovascular Ultrasound| August 03, 2017
Carestream will showcase its Carestream Touch Prime and Touch Prime XE Ultrasound Systems at the Society for Vascular...
Hitachi and West Virginia University Partner to Advance Left Ventricular Mechanical Function Evaluation
News | Cardiovascular Ultrasound| July 21, 2017
Hitachi Healthcare and the West Virginia University Heart and Vascular Institute announced the formation of a new...
3-D Vascular Ultrasound Quantifies Plaque Burden to Estimate Cardiovascular Risk
News | Cardiovascular Ultrasound| July 20, 2017
July 20, 2017 — In a large, first-of-its-kind population, researchers found an experimental technique known as...
Floyd Medical Center Acquires Quartet of Toshiba Cardiac Ultrasound Systems
News | Cardiovascular Ultrasound| July 19, 2017
Floyd Medical Center in Rome, Ga., recently installed three new Aplio 500 Platinum CV ultrasound systems from Toshiba...
Cardiac CT scan showing plaque and calcification in the coronary arteries, from a Toshiba CT scanner
News | Business| July 19, 2017
July 19, 2017 — The Society of Cardiovascular Computed Tomography (SCCT) created a reimbursement fee chart for cardia
Sponsored Content | Videos | Cardiovascular Surgery| July 19, 2017
This video educational session, provided in partnership with the American Society of Echocardiography (ASE), is title
Overlay Init