‘A significant milestone’: First US patients receive doses of new PET radiotracer for CAD
U.S. patients are now receiving doses of GE HealthCare’s new PET radiotracer, flurpiridaz F-18, for the first time since it gained U.S. Food and Drug Administration (FDA) approval.
Flurpiridaz F-18 is a PET myocardial perfusion imaging (MPI) radiotracer designed to improve the detection of coronary artery disease (CAD). The FDA approved its use for patients with known or suspected CAD last September after years of research and speculation. Industry experts immediately started speculating that the news could lead to an increased adoption of PET due to its superior sensitivity and specificity compared to SPECT, as well as its potential to help healthcare providers see significant cost savings. Flurpiridaz F-18 is also associated with a much longer half-life than existing PET MPI radiotracers, yet another reason so many in the nuclear cardiology community celebrated the approval.
GE HealthCare markets and sells flurpiridaz F-18 under the brand name Flyrcado. The company is celebrating the launch of the radiotracer at ACC.25 in March, but initial doses have already been rolled out to select facilities, including Houston Methodist Hospital.
“The first patient doses of Flyrcado mark a significant milestone in the journey of this product which has been more than a decade in the making,” Kevin O’Neill, CEO of the pharmaceutical diagnostics segment of GE HealthCare, said in a statement. “These imaging centers are leading the way in cardiac imaging, and we are pleased they have recognized the impact this diagnostic—which has been called a game-changer—can make both for their clinicians and their patients.”
“Flyrcado opens new frontiers for cardiac PET with a significantly longer half-life than existing PET MPI tracers, and we are proud to be one of the first to use it in our cardiac PET lab,” added cardiologist Mouaz Al-Mallah, MD, MSc, director of cardiac PET at Houston Methodist Hospital. “The longer half-life eliminates the need for onsite tracer manufacturing so it can be ordered as a ready-to-use unit dose. Additionally, it offers clinicians the flexibility to perform exercise stress testing—something not feasible with any previously available cardiac PET tracer. We anticipate Flyrcado will make PET MPI more accessible to clinicians and patients and allow more centers to provide this important imaging modality to appropriate patients.”
Lead researcher excited by radiotracer’s potential
Jamshid Maddahi, MD, director of the Biomedical Imaging Institute at UCLA, led the research that ultimately led to the FDA’s approval of flurpiridaz F-18. He spoke with Cardiovascular Business about the radiotracer’s potential impact on patient care soon after it gained approval.
“This could be a paradigm shift,” Maddahi said at the time. “With flurpiridaz, we have a radiotracer that not only surpasses SPECT in terms of diagnostic performance but also offers enhanced confidence for clinicians. This is a long-awaited development in nuclear cardiology, and I believe it will lead to much greater use of PET in the diagnosis and management of heart disease.”
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.