VIDEO: 'The results were striking': How newly approved flurpiridaz compares to SPECT

For the first time in three decades, the U.S. Food and Drug Administration (FDA) has approved a new PET nuclear myocardial perfusion imaging agent, flurpiridaz F-18, branded Flyrcado by GE HealthCare. The FDA’s clearance follows the pivotal AURORA Phase III clinical trial,[1] which demonstrated that this novel radiotracer outperforms SPECT, the current standard for cardiac nuclear perfusion imaging. The results of the trial and FDA clearance could mark a major shift toward more widespread adoption of PET in nuclear cardiology.

The AURORA trial was led by Jamshid Maddahi, MD, a professor of molecular and medical pharmacology at UCLA and director of the Biomedical Imaging Institute at UCLA. In an interview with Cardiovascular Business, Maddahi reviewed key highlights from the trial, which he believes will spur wider adoption of cardiac PET.

"The trial focused on comparing the diagnostic performance of flurpiridaz against both invasive coronary angiography and the currently widely used SPECT imaging with technetium-99m (99mTc)," Maddahi said. "The results were striking. Flurpiridaz demonstrated a significantly higher diagnostic accuracy, especially in subgroups where SPECT has traditionally been less effective, such as female and obese patients."