Technology | Contrast Media | July 15, 2019

FDA Approves Bayer's Gadavist Contrast for Cardiac MRI in Adult Coronary Artery Disease Patients

Gadavist (gadobutrol) becomes first contrast agent FDA-approved for use in cardiac MR

FDA Approves Bayer's Gadavist Contrast for Cardiac MRI in Adult Coronary Artery Disease Patients

July 15, 2019 — The U.S. Food and Drug Administration (FDA) has approved Gadavist injection for use in cardiac magnetic resonance imaging (MRI) to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD). Gadavist (gadobutrol) is now the first and only contrast agent FDA-approved for use in cardiac MR, an important diagnostic tool for patients with CAD.

"Gadobutrol-enhanced cardiac MR demonstrated efficacy in a large global multicenter clinical trial," said Daniel S. Berman, M.D., FACC, chief of cardiac imaging and nuclear cardiology at the Cedars-Sinai Heart Institute and the S. Mark Taper Foundation Imaging Center. "The FDA approval is a landmark for making this validated, non-invasive method available to healthcare professionals to evaluate their patients for the most common form of heart disease in the world."

The approval was based on two 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. First approved in 2011, cardiac MR is now the fourth FDA-approved indication for Gadavist.2

The Society for Cardiovascular Magnetic Resonance (SCMR) recognizes cardiac MR as a non-invasive tool that provides relevant and actionable information to healthcare professionals.3

"We now have an approved contrast agent for use in cardiac MR to assess perfusion and late gadolinium enhancement in less than one hour," said Scott Flamm, M.D., MBA, head of cardiovascular imaging, Cleveland Clinic. "A Gadavist-enhanced cardiac MR is a key diagnostic tool, providing additional important clinical information, which can help physicians manage their patients with known or suspected CAD."

A disease that affects approximately 16.5 million Americans, CAD develops when the major blood vessels that supply the heart with blood, oxygen and nutrients (coronary arteries) become damaged or diseased.1,5 Cholesterol-containing deposits (plaque) in the arteries and inflammation are usually the cause of CAD. When plaque builds up, it narrows the coronary arteries, decreasing blood flow to the heart. Eventually, the decreased blood flow may cause chest pain (angina), shortness of breath, or other coronary artery disease signs and symptoms. A complete blockage can cause a heart attack.4

For more information: www.radiologysolutions.bayer.com

References

1. Cleveland Clinic. Coronary Artery Disease. https://my.clevelandclinic.org/health/diseases/16898-coronary-artery-disease. Updated May 14, 2019. Accessed May 23, 2019.

2. Gadavist (gadobutrol) Injection. Prescribing Information. Whippany, New Jersey, USA: Bayer Pharmaceuticals, Inc.

3. Society for Cardiovascular Magnetic Resonance: Why CMR. (n.d.). https://scmr.org/page/WhyCMR. Accessed May 23, 2019.     

4. Mayo Clinic. Coronary Artery Disease. https://www.mayoclinic.org/diseases-conditions/coronary-artery-disease/symptoms-causes/syc-20350613. Updated May 16, 2018. Accessed May 23, 2019.

Related Content

Smoldering Spots in the Brain May Signal Severe MS

NIH researchers found that dark rimmed spots representing ongoing, “smoldering” inflammation, may be a hallmark of more disabling forms of multiple sclerosis. Image courtesy of Reich lab, NIH/NINDS.

News | Neuro Imaging | August 22, 2019
Aided by a high-powered brain scanner and a 3-D printer, National Institutes of Health (NIH) researchers peered inside...
Vaping Impairs Vascular Function

Image courtesy of the American Heart Association

News | Magnetic Resonance Imaging (MRI) | August 21, 2019
Inhaling a vaporized liquid solution through an e-cigarette, otherwise known as vaping, immediately impacts vascular...
Jackson Memorial Hospital Holds Ribbon-cutting for New Cardiac Catheterization Labs
News | Angiography | August 21, 2019
Jackson Memorial Hospital in Miami celebrated the opening of two newly renovated cardiac catheterization suites during...
Videos | Treatment Planning | August 21, 2019
This is an example of the Mirada DLCExpert deep learning software that automatically identifies organs, segments and
Videos | Patient Positioning Radiation Therapy | August 21, 2019
This is a quick demonstration of the Varian Identify image-guided patient positioning system at the...
Videos | Treatment Planning | August 21, 2019
This is a lung cancer tumor radiotherapy...
Videos | Computed Tomography (CT) | August 21, 2019
This is a quick walk around of a mobile 32-slice...
Improved Imaging Technique Could Increase Chances of Prostate Cancer Survival
News | Prostate Cancer | August 20, 2019
According to the American Cancer Society, approximately one in nine men will be diagnosed with prostate cancer in their...
Some Pregnant Women Are Exposed to Gadolinium in Early Pregnancy
News | Women's Health | August 20, 2019
A small but concerning number of women are exposed to a commonly used magnetic resonance imaging (MRI) contrast agent...