TL/DR –
The US FDA has approved GE Healthcare’s first PET myocardial perfusion imaging radiotracer, flurpiridaz F-18, for detecting coronary artery disease (CAD). GE will market the radiotracer as Flyrcado, a tool that offers higher diagnostic efficacy than single-photon emission computed tomography (SPECT) currently used in nuclear cardiology. The approval of Flyrcado, which can be manufactured offsite and delivered as a ready-to-use unit, is expected to expand clinician and patient access to PET myocardial perfusion imaging, and improve diagnostic accuracy in difficult-to-image patients, such as those with high BMI and women.
Flurpiridaz F-18 Receives FDA Approval for Coronary Artery Disease Detection
GE HealthCare’s positron emission tomography (PET) myocardial perfusion imaging radiotracer, flurpiridaz F-18, has received approval from the U.S. Food and Drug Administration (FDA). The radiotracer, set to be marketed as Flyrcado, will be a significant advancement in nuclear imaging technology.
The tool, which has been a hot topic in recent American Society of Nuclear Cardiology (ASNC) annual meetings, is indicated for patients with known or suspected coronary artery disease. It offers superior diagnostic efficiency compared to traditional single-photon emission computed tomography (SPECT) MPI and is especially valuable for difficult-to-image patients, such as those with a high BMI.
Flurpiridaz, which boasts a half-life of 109 minutes, presents a significant improvement over the commonly used tracer rubidium-82. The longer half-life of flurpiridaz allows for more flexible scanning options, including the possibility of rescanning within a single session.
Noted cardiologist Jamshid Maddahi, MD, has described flurpiridaz as a game changer, stating that it will make advanced PET imaging more accessible for a larger group of patients.
Flurpiridaz Poised to Drive Expansion of PET Adoption
Despite PET and SPECT’s superior image quality, cost and limited access to radiotracers have been major barriers to widespread adoption. However, the introduction of Flyrcado could help address these issues, according to Maddahi. Furthermore, the FDA’s clearance of flurpiridaz is expected to pave the way for more economical PET nuclear imaging, as its unit doses on demand are more cost-effective than rubidium-82 generators.
Mouaz Al-Mallah, MD, MSc, of Houston Methodist Hospital, shared his optimism about the potential of flurpiridaz. He noted that its beneficial properties and convenience could help shift the balance in favor of PET investments.
ASNC and GE HealthCare have expressed enthusiasm for proposed reforms to the 2025 Medicare Physician Fee Schedule (MPFS) and the Hospital Outpatient Prospective Payment System (HOPPS). These reforms could increase revenues from PET and encourage more hospitals to adopt new PET programs.
For more information, check out this article on the impact of these potential CMS changes.
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