Bayer received FDA approval for Gadavist

the U.S. Food and Drug Administration (FDA) has approved Bayer's Gadhavist as the first and only heart magnetic resonance imaging (CMRI) agent for patients with coronary artery disease.
The injection has been approved for the evaluation of heart muscle perfusion and advanced radon enhancement in adult patients with known or suspected coronary artery disease (CAD).
The approval is based on two prospective, open-label, non-randomized, multi-center, blind-spot reading Phase III studies that investigated the diagnosis of a lycol-enhanced heart MRI to assess significant coronary artery disease.
Cardiac magnetic resonance imaging is a non-invasive imaging technique for non-invasive assessment of cardiovascular system function and structure, and the approval is to enable "medical professionals to use proven non-invasive methods to evaluate their patients" iconic world's most common form of heart disease," said Daniel Berman, director of cardiac imaging and nuclear cardiology at the Cedars-Sinai Heart Institute.
The technique is derived from and based on the same basic principles as magnetic resonance imaging, but is optimized for use in the cardiovascular system.
Thomas Balzer, Director of Radiology for Bayer Medical and Clinical Affairs, said: "Gadavist's approval to expand its use is significant news for the 16.5 million patients affected by coronary artery disease in the United States because it provides them with a very powerful non-invasive diagnostic option. "
industry leader in contrast media, we are committed to driving science through innovation, which is critical for patients," he continued. The use of contrast-enhanced coronary artery disease in patients with known or suspected coronary artery disease will provide cardiologists and radiologists with important information about myocardial function to support the management of patients with this highly endemic disease. corona ry artery disease
is the most common type of heart disease in the United States, as up to half of middle-age men and one-third of middle-age women in the United States have a lifetime risk of coronary artery disease.
The condition develops when the main blood vessels that supply the heart with blood, oxygen, and nutrients (coronary arteries) are damaged or sickened, and plaques build up in the arteries, reducing blood flow to the heart. (Compiled by this web)