GE Healthcare Medical Diagnostics announced that it has re-introduced its Optison, a contrast agent used with ultrasound for echocardiogram. It is a Perflutren Protein-Type A Microspheres Injectable Suspension, USP. Optison is indicated to be used with patients with sub-optimal echocardiograms in order to enhance the delineation of the left ventricular endocardial borders. However, the safety of Optison with pharmacologic or exercise stress is not established yet.
Kimberly Wolf, Regional Marketing Leader - Americas, GE Healthcare Medical Diagnostics "We are excited to announce the reintroduction of Optison,” adding “The product gives medical professionals an option in ultrasound contrast agents when they need to increase diagnostic accuracy by converting non-diagnostic echo studies to diagnostic images.” Optison has an FDA approval in 1998. However, GE Healthcare stopped supplying it to the market in June 2009 as a result to difficulties in manufacturing. After reviewing production process, GE is now able to provide Optison again. Anthony N. DeMaria, MD, Professor of Medicine, Judith and Jack White Chair in Cardiology at the University of California, San Diego School of Medicine, said “Optison gives cardiologists, sonography professionals, cardiac catheterization laboratory nurses, echocardiography laboratory staff, and most importantly patients, an additional option in ultrasound contrast agent selection,”
Data from the Intersocietal Commission for the Accreditation of Echocardiography Laboratories (ICAEL) say that nearly 10 million echocardiograms are carried out in the US annually. Moreover, about 30% of patients undergoing stress echocardiography have non-diagnostic or reduced-quality images. Therefore, echocardiographic contrast agents were developed to enhance the quality of images. Studies show that suboptimal echocardiograms could be changed into diagnostic images in 75% to 90% of cases. Steven B. Feinstein, MD, FACC, FESC, Professor of Medicine and Director of Echocardiography, Rush University Medical Center, Chicago, said “I am pleased that Optison is back on the market because it offers an important tool for improving the accuracy and reliability of echocardiograms, without unnecessarily exposing patients to ionizing radiation or dye,” he added “By improving the accuracy of echocardiograms, the use of ultrasound contrast agents also avoids redundant downstream testing."