CRT 2019: US FDA approves resting full-cycle ratio for measuring severity of coronary artery blockages

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Abbott has announced the US FDA clearance of the resting full-cycle ratio (RFR) diagnostic test to identify significant narrowing of arteries in patients with coronary artery disease. According to a press release, physicians can use Abbott’s RFR diagnostic test to detect the severity of coronary artery stenosis at rest, without administering potentially costly drugs known to cause patients discomfort and to lengthen procedures.

RFR measures the entire cardiac cycle resulting in an unbiased assessment of the heart at rest. It does not require the use of vasodilators.

At the 2019 Cardiovascular Research Technologies (CRT) meeting (2–5 March, Washington, DC, USA), the results of the RE-VALIDATE study—an all-comers prospective analysis of retrospective real-world hospital data—were presented. During the study, RFR demonstrated equivalence against instantaneous wave-free ratio (iFR with overall diagnostic accuracy of 97.8%.

Ziad A Ali (Center for Interventional Vascular Therapy, Columbia University Medical Center, New York, USA), says: “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 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 uniquely designed for confident and accurate physiology measurements.

Charles Simonton, chief medical officer of Abbott’s vascular business, comments: ““The FDA clearance of our RFR diagnostic tool offers doctors benefits that have not been available, allowing for more accurate measurements. Advances like RFR give doctors more options to make the most informed treatment decision for each individual patient.”

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