GE Healthcare today announced that it has submitted an application to amend its European Marketing Authorisation that will allow the company to manufacture Optison™ 0.19 mg/ml dispersion for injection within its own facility. Upon approval, GE Healthcare will provide supply of Optison to the EU market from its manufacturing facility in Oslo, Norway.
“Adding our own manufacturing site for Optison has multiple benefits, including an ability to increase capacity to meet market demands and ensuring robust and secure stock. We look forward to serving the EU contrast media market.”
Optison is a transpulmonary echocardiographic contrast agent for use in patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers, enhance left ventricular endocardial border delineation with resulting improvement in wall motion visualisation. Optison should only be used in patients where the study without contrast enhancement is inconclusive.
"GE Healthcare is committed to providing safe, reliable, innovative, and effective diagnostic products that aid in the detection of cardiovascular diseases, and today's filing is further evidence of our commitment," said Ben Newton, Global Product Leader, Ultrasound, GE Healthcare Medical Diagnostics. "Adding our own manufacturing site for Optison has multiple benefits, including an ability to increase capacity to meet market demands and ensuring robust and secure stock. We look forward to serving the EU contrast media market."
Optison remains an important diagnostic option for patients with suboptimal echocardiograms. Additionally, Optison offers a unique, convenient value to clinicians and patients: It is stable at room temperature for up to 24 hours and takes less than 60 seconds to prepare, allowing for quick access to contrast in hospital settings like the cardiac lab or emergency room.