FDA approves GE Healthcare molecular imaging agent for cardiac risk evaluation

24 March 2013 (Last Updated March 24th, 2013 18:30)

The US Food and Drug Administration (FDA) has approved a new indication for GE Healthcare's molecular imaging agent for the evaluation of cardiac risk in heart failure patients.

The US Food and Drug Administration (FDA) has approved a new indication for GE Healthcare's molecular imaging agent for the evaluation of cardiac risk in heart failure patients.

Approved for the scintigraphic assessment of myocardial sympathetic innervation (cardiac nerve activity), AdreView (Iobenguane I 123 Injection) radiopharmaceutical agent evaluates patients with New York Heart Association (NYHA) Class II or Class III heart failure and left ventricular ejection fraction (LVEF) =35%.

Evaluation of heart failure and LVEF can help identify patients with one and two-year mortality risks as indicated by an H/M ratio =1.6, a measure of radioactivity uptake in the heart compared to that of a reference region in the mediastinum, according to the company.

American Society of Nuclear Cardiology president and Brown University medicine associate professor Dr James Arrighi said currently there are a limited number of prognostic tools available to help clinicians understand the likelihood for heart failure progression.

"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," Arrighi said.

The company said the safety and efficacy of the product were evaluated in open-label, multicentre, international trials in 985 patients with NYHA class II or class III heart failure with LVEF =35%.

A total of 110 patients without a history of heart disease also received a single dose of AdreView.

All-cause mortality, an outcome confirmed by an independent adjudication committee, was the endpoint for analysis.

GE Healthcare medical diagnostics SPECT general manager Terri Moench said; "The use of imaging tests is consistent with current trends towards gaining improved and earlier understanding of heart disease at a molecular level and may enable providers to help deliver better care to more people."