Bayer wins FDA approval for Gadavist

The injection has been approved to assess myocardial perfusion and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD). The approval is based on two prospective, open-label, non-randomised, multi-centre, blinded-read Phase III studies, which investigated the diagnostic results of gadobutrol-enhanced cardiac MRI for the evaluation of significant CAD. Cardiac MRI is a medical imaging technology for the non-invasive assessment of the function and structure of the cardiovascular system, and the approval is a “landmark” for making the “validated, non-invasive method available to healthcare professionals to evaluate their patients for the most common form of heart disease in the world,” according to Daniel Berman, chief 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 MRI, however with optimisation for use in the cardiovascular system.

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