Abbott receives clearance of new diagnostic to measure severity of coronary artery blockages without stressing heart

Abbott has announced the Food and Drug Administration (FDA) clearance of the Resting Full-cycle Ratio (RFR) diagnostic test to identify significant narrowing of arteries in patients with coronary artery disease. Physicians can use Abbott’s RFR diagnostic test to detect the severity of coronary artery stenosis – the significant narrowing of arteries – at rest, without administering potentially costly drugs known to cause patients discomfort and to lengthen procedures.

Diagnostics like RFR determine the pressure in an artery and provide cardiologists with an objective measurement that helps identify blockages and determine which vessels would benefit most from receiving a coronary stent. RFR measures the entire cardiac cycle resulting in an unbiased assessment of the heart at rest. It does not require the use of vasodilators – medicines that dilate blood vessels and cause the heart to be stressed.

Late-breaking trial results from the RE-VALIDATE study, an all-comers prospective analysis of retrospective real-world hospital data, were presented yesterday at the Cardiovascular Research Technologies (CRT) 2019 conference in Washington, D.C. During the study, RFR demonstrated equivalence against instantaneous wave-free ratio (iFR), an older version of resting coronary artery stenosis severity assessment, with overall diagnostic accuracy of 97.8 percent.1

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.

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