FDA Approves AdreView for Cardiac Risk Evaluation in Heart Failure Patients

Nuclear Cardiology Continues to Play Important Role in Assessment and Prognosis of Heart Disease
FDA Approves AdreViewTM for Cardiac Risk Evaluation in Heart Failure Patients

BETHESDA, MD -- April 16, 2013 -- The U.S. Food and Drug Administration (FDA) has approved AdreView, the first and only FDA approved molecular imaging agent to link the nerve function in the heart to a patient's mortality risk. GE Healthcare's AdreView is the first imaging agent approved for visualization of myocardial sympathetic innervation in certain heart failure patients.

"Heart failure is a common, severe chronic condition, and can be quite challenging to manage. Currently, there are a limited number of tools available to help clinicians assess a patient's prognosis with heart failure," said James A. Arrighi, MD, Associate Professor of Medicine at Brown University and current president of the American Society of Nuclear Cardiology (ASNC). "Now, with AdreView, we have a tool that will provide clinicians with a numeric score to help stratify mortality risk, and may help to promote more informed clinical decision-making."

In clinically challenging patients, a test that helps to identify the subset of heart failure patients with a lower mortality risk may help physicians with more informed clinical decision-making. The use of imaging tests is consistent with current trends toward gaining improved and earlier understanding of heart disease at a molecular level and may enable preventive management strategies.

The introduction of AdreView is an important advance in nuclear cardiology. Nuclear cardiology has played a pivotal role in the diagnosis, assessment, and outcome of heart disease. Coronary artery disease results from the narrowing of the blood vessels that supply the heart. Tests involving nuclear cardiology use noninvasive techniques to assess myocardial blood flow, evaluate the pumping function, and now, assess innervation of the heart. Nuclear cardiology procedures utilize tracers that enable visualization of physiological processes in the heart.

"New advances that provide more information to physicians, aid in the prognosis of cardiovascular disease, and enhance patient outcome bring value to the entire healthcare community," said Kathleen B. Flood, CEO of the American Society of Nuclear Cardiology. "Innovations such as AdreView increase the quality and value of testing and are essential tools that further support physicians as judicious stewards of healthcare resources."

With continued advancements, such as AdreView, nuclear cardiology will continue to play an important role in the noninvasive assessment of patients with heart disease.

For more information, go to the American Society of Nuclear Cardiology's website at www.asnc.org.

About the American Society of Nuclear Cardiology
The American Society of Nuclear Cardiology (ASNC) is dedicated to excellence in imaging and works to educate the broader medical community, policymakers, and patients about the value of nuclear cardiology. ASNC is committed to Appropriate Use, quality assurance, and patient-centered imaging. ASNC provides professional education, advocacy, and quality guidelines to its international membership of over 4,500 physicians, radiologists, technologists, nurses, and scientists all involved in the nuclear cardiovascular field. For more information about ASNC, please visit the Society's website at: www.asnc.org.