GE Healthcare's medical diagnostic division has announced the market reintroduction in Europe of Optison, a diagnostic ultrasound contrast agent.
The product is now available in Germany, Italy, Spain, Austria, the Nordic countries, and the U.K., with availability in other countries planned for the near future.
Optison is indicated for use in patients with suboptimal echocardiograms with suspected or established cardiovascular disease to provide opacification of cardiac chambers. Its ability to enhance left ventricular endocardial border delineation helps improve wall motion visualization. More than 1 million doses of the agent have been administered to patients worldwide, and during nearly 12 years of clinical use, there were only 16 reported serious adverse effects, according to GE Healthcare.
The European Association of Echocardiography recommends the use of contrast whenever two or more left ventricular wall segments are not seen on noncontrast images.
GE Healthcare has not sold Optison in Europe since removing it from the market in November 2005 due to good manufacturing practice issues at the company's plant in the U.S.