Novel Drug & Emergent Therapeutics | Radiology
FDA Approves Flyrcado™: A Game-Changer in PET Imaging for Coronary Artery Disease Diagnosis
Time to read: 1 minute, 15 seconds
Originally published: 27 September 2024
Source: GE HealthCare
Type of article: Novel Drug & Emergent Therapy News
MedED Catalogue Reference: MNDRI001
Category: Radiology
Crossreference: Cardiology
Keywords: radiology, PET, MPI, Perfusion imaging, Coronary Arter Disease
| Product Category | Product Name | Company | Status |
|---|---|---|---|
| FDA Approved |
27th September 2024, GE HealthCare Press Release
GE HealthCare has secured FDA approval for Flyrcado™ (flurpiridaz F 18), the first-ever PET myocardial perfusion imaging (MPI) agent for detecting coronary artery disease (CAD).
Flyrcado offers enhanced diagnostic efficacy over SPECT MPI, the current nuclear cardiology standard. Due to its extended half-life of 109 minutes, the agent simplifies distribution logistics by enabling offsite production and delivery, reducing the need for on-site generator maintenance, and allowing hospitals and imaging centres to use it more easily.
This longer half-life also allows the agent to be paired with exercise stress testing, a first in PET MPI imaging, providing a robust assessment of ischemia in patients.
The agent was evaluated in the AURORA Phase III clinical trial, where it was compared to invasive coronary angiography and SPECT MPI, showing superior performance in diagnosing CAD. Clinicians can also rescan patients during the same session in the event of technical issues, enhancing the efficiency of the diagnostic process.
As part of GE HealthCare’s portfolio, Flyrcado joins other FDA-approved PET agents like Cerianna™ and Vizamyl™, expanding GE’s molecular imaging capabilities. It will be available in U.S. markets by early 2025, with further expansion to follow, providing clinicians and patients with more access to advanced cardiac diagnostics.
Access Original Press Release
27 September 2024 | GE HealthCare announces FDA approval of Flyrcado (flurpiridaz F 18) injection PET radiotracer for enhanced diagnosis of coronary artery disease
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