Technology | Contrast Media | July 15, 2019

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

News | Pediatric Imaging

May 24, 2023 — A new advanced form of computed tomography (CT) imaging called photon-counting computed tomography (PCCT) ...

Time May 24, 2023
arrow
News | Radiology Imaging

May 19, 2023 — Asymptomatic adults with a high accumulation of fat in their muscles, known as myosteatosis, are at an ...

Time May 19, 2023
arrow
News | Teleradiology

May 17, 2023 — Online workflow systems for off-site radiologists are one reason for health care delays that cost ...

Time May 17, 2023
arrow
News | Contrast Media

May 16, 2023 — Bracco Imaging, an innovative world leader delivering end-to-end products and solutions through a ...

Time May 16, 2023
arrow
News | Contrast Media

May 15, 2023 — Guerbet, a global leader in medical imaging with more than 30 years of experience in MRI, announced that ...

Time May 15, 2023
arrow
News | Radiation Therapy

May 15, 2023 — GE HealthCare is presenting three new global innovations – Intelligent Radiation Therapy (iRT), Auto ...

Time May 15, 2023
arrow
Feature | Radiographic Fluoroscopy (RF) | By Mohammad Sahebjalal, MD

Invented in 1896 by Enrico Salvioni, the fluoroscope remains a flagship technology of modern medicine. The live video X ...

Time May 04, 2023
arrow
Feature | Contrast Media | By Christine Book

In the past year, the radiology community has been a first-hand, hands-on witness to myriad unexpected challenges and ...

Time May 03, 2023
arrow
Feature | X-Ray | By Samuel Browd, MD, PhD

Modalities used in spine surgery, like computed tomography (CT) scan-based navigation systems and even X-rays, reached a ...

Time May 02, 2023
arrow
Feature | Magnetic Resonance Imaging (MRI) | By Johnson Polakkal Joseph

Magnetic resonance imaging (MRI) is a technology that has been around for more than four decades and is a staple in ...

Time May 01, 2023
arrow
Subscribe Now