Abbott said that FDA has cleared its resting full-cycle ratio (RFR) diagnostic test to identify significant narrowing of coronary arteries in patients with coronary artery disease.
RFR is assessed using the wireless PressureWire X guidewire, which Abbott acquired when it bought St. Jude Medical in 2017. The RFR non-hyperemic index scans through diastole and systole for the largest drop in pressure over the entire cardiac cycle. It was designed to provide cardiologists with an objective measurement that helps identify blockages and determine which vessels would benefit most from receiving a coronary stent. RFR technology can also help cardiologists determine the most significant blockage in arteries with multiple lesions, and provides full encryption of patient data, the company added.
Because RFR does not require the use of vasodilators — drugs that can stress the heart — it can potentially reduce side effects, procedural time and cost, according to Abbott. RFR has been studied in more than 2,000 lesions, the company’s website notes.
During a recent 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%, the company noted. Late-breaking trial results from the study were presented yesterday at the Cardiovascular Research Technologies conference in Washington, D.C.
“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,” said Ziad Ali, M.D., director of intravascular imaging and physiology at Columbia University Medical Center’s Center for Interventional Vascular Therapy, in a statement from Abbott. “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.”
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