FDA Clears Abbott's Resting Full-Cycle Ratio Diagnostic Test

March 5, 2019—Abbott announced FDA clearance of the Resting Full-Cycle Ratio (RFR) diagnostic test to identify significant narrowing of arteries in patients with coronary artery disease. The RFR diagnostic test can be used to detect the severity of coronary artery stenosis at rest, without administering potentially costly drugs known to cause patients discomfort and to lengthen procedures.

In Abbott's announcement, Ziad A. Ali, MD, commented, “Accuracy in identifying the severity of arterial narrowing or blockages is critical in guiding if and when a stent should be implanted, avoiding unnecessary procedures. Abbott’s RFR provides interventionalists with a new, effective method of analysis that identifies important stenoses with the least discomfort, offering a better experience for patients.”

The company noted that late-breaking trial results from the RE-VALIDATE study, an all-comers prospective analysis of retrospective real-world hospital data, were presented at CRT 2019, the Cardiovascular Research Technologies annual meeting held March 2–5 in Washington, DC. In the study, RFR demonstrated equivalence against instantaneous wave-free ratio, with an overall diagnostic accuracy of 97.8%.

The RFR technology also offers capabilities to determine the most significant blockage in arteries with multiple lesions and offers improved security with full encryption of patient data. Additionally, it will be used with the new wireless PressureWire X, which is designed for confident and accurate physiology measurements, advised Abbott.