FDA Approves Bracco Diagnostics’ Lumason as New Ultrasound Imaging Agent
The U.S. Food and Drug Administration, FDA, has approved Lumason, a brand of sulfur hexafluoride lipid microsphere produced by Bracco Diagnostics Inc., for use by patients whose echocardiograms (ultrasound image of the heart) is difficult to view with ultrasound waves.
Lumason, a contrast agent, is composed of gas-filled microbubbles, also called microspheres. The action of the gas-filled microbubbles is to reflect the sound waves in such a way as to significantly improve the image.
Lumason therefore enables clearer images to be produced of the left ventricle chamber, the inside of the heart chambers, including the endocardium, which is the smooth edge of the chambers.
This enables physicians to be able to have a clearer view of patients’ hearts and consequently be able to treat the patient more effectively.
The FDA has confirmed Lumason to be safe and effective for human use from three clinical trials that were carried out using 191 patients with heart problem, and whose echocardiograms were hard to read and interpret by doctors.
Having used 2 milliliter dose of Lumason, the imaging for the majority of the patients were significantly clearer in all three studies and the doctors were then able to view the lining of the left ventricle clearer.
Lumason shows headache and nausea as commonly reported side effects. However, like other microbubble contrast agents, Lumason displays a boxed warning of the risk that could be associated with its use, which may include acute cardiopulmonary reactions, such as a grave cardiac arrest.
Patients with some kinds of heart conditions are more predisposed to these risks, with most serious reactions occurring about 30 minutes after it is administered.
Bracco Diagnostics Inc., the company that makes Lumason is a subsidiary of Bracco Imaging SpA. Bracco Imaging is a global diagnostic imaging business with presence in over 90 countries.
Bracco Diagnostics Inc. specializes in developing and marketing of imaging agents whose use can be applied in x-ray/CT, MRI, nuclear medicine, and ultrasound in the U.S. and Canada. Its headquarters is in Township, NJ.