Wednesday, medical devices maker St. Jude Medical Inc. (STJ) said that it is welcoming the updated level of evidence for Fractional Flow Reserve or FFR-guided treatment in the Guidelines on Percutaneous Coronary Intervention or PCI. FFR specifically identifies which coronary narrowings are responsible for significantly obstructing the flow of blood to a patients' heart muscle, and it is used by the interventional cardiologist to direct coronary interventions and assess results for improved treatment outcomes.
The American College of Cardiology, American Heart Association, Society for Cardiovascular Angiography and Interventions or SCAI guidelines upgrade the level of evidence for FFR, a physiological measure of coronary stenosis, from a "B" to an "A" because of new research conducted to determine its efficacy; the landmark FAME trial demonstrated improved outcome for patients with multivessel coronary artery disease whose treatment was guided by St. Jude Medical FFR Measurement Systems rather than by standard angiography alone.
The updated recommendation for FFR was issued in response to the important FAME trial data, which demonstrated many patient benefits, including a 34% reduced risk of combined death or heart attack for those whose treatment was guided by St. Jude Medical's PressureWire Certus technology prior to coronary stenting rather than angiography alone.
The recommendations supported by a level of evidence "A" state that FFR can be useful in assessing whether an intervention in a coronary lesion(s) is necessary, as an alternative to noninvasive functional testing, and to help assess intermediate stenosis in patients with anginal symptoms. The guidelines also suggest that FFR can be useful to optimize clinical outcomes.
The FAME study was a randomized, prospective, multi-center trial which enrolled 1,005 patients with multivessel coronary artery disease. It compared outcomes for patients whose treatment was guided by FFR to those whose treatment was guided only by angiography.
STJ is traded at $38.35 up $0.13 or 0.34% on the NYSE.
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