Health Canada Approves Cardiac AdreView; Launch of ADMIRE-ICD Clinical Trial
Health Canada has approved a cardiac indication for AdreView (Iobenguane I 123 Injection). In Canada, AdreView is indicated for scintigraphic assessment of sympathetic innervation of the myocardium in patients with NYHA II-III HF and LVEF ≤35 percent.In these patients, AdreView may be used as an adjunct test to other established tools to further assess mortality risk.
GE Healthcare also launched ADMIRE-ICD, a phase IIIb, multicenter, randomized study to evaluate the efficacy of AdreView for appropriately guiding ICD implantation in NYHA II-III HF patients with 30 percent ≤ LVEF ≤ 35 percent, and for identifying patients at low SCD risk who may not benefit from an ICD. The primary endpoint is all-cause mortality; secondary endpoints include CV death, hospitalization, shocks and resource utilization. 2,216 patients will be recruited in North America and Europe. More information