The U.S. Food and Drug Administration (FDA) has approved CMR to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD). Contrast-enhanced cardiac MRI demonstrated efficacy and safety in a global multi-center clinical trial setting at a standard dose of 0.1ml per kilogram of body weight. This new development will provide a new diagnostic tool to provide additional clinical information in less than one hour to help healthcare professionals manage their patients with known or suspected CAD.
This approval was based on the GadaCAD trials; two prospective, multinational, non-randomized, blinded-read Phase 3 studies of almost 1,000 adults with suspected or known CAD based on signs and symptoms. Nearly 800 of those patients were evaluated for efficacy. The GadaCAD trail builds on the existing scientific data that validates cardiac MRI, which includes the recent publishing of the MR-INFORM study
This milestone further validates the use of cardiac MRI as a key diagnostic tool and gives the 16.5 million patients with Coronary Artery Disease (CAD) an additional non-invasive diagnostic tool.
