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."