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Data From FAME II Trial Concludes FFR-Guided PCI Is Cost Effective And Improves Patient Outcomes

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced that Fractional Flow Reserve (FFR)-guided treatment using PressureWire was cost effective for coronary interventions when compared to the best available medical therapy. Cost utility analysis data from the FAME II trial was presented as a late-breaking clinical trial at the 24 th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

Three-year projected results derived from FAME II trial data revealed that FFR-guided percutaneous coronary intervention (PCI) plus medical therapy had an incremental cost-effectiveness ratio (ICER) of $32,000 per quality-adjusted life year (QALY) compared to medical therapy alone in treating patients with stable coronary artery disease. For comparison, a common threshold of $50,000 per QALY is often cited when evaluating the cost effectiveness of therapies. Interventions with ICERs from $50,000 to $150,000 per QALY are thought to be cost-effective and those below $50,000 per QALY are considered highly cost effective per thresholds established by the World Health Organization. Results reported in FAME II cost-effectiveness data are well below that threshold.

While FFR-guided PCI had a higher initial cost than patients treated by medical therapy alone, after one year the cost gap narrowed by more than 50 percent due to a higher number of hospital re-admissions for patients treated only with medical therapy.

Clinical results from the FAME II trial previously established that FFR-guided PCI plus medication improves patient outcomes. Cost-effectiveness analysis also found that the use of St. Jude Medical PressureWire™ FFR measurement technology (which measures blood flow restriction in the coronary arteries) for patients treated with FFR-guided PCI plus medical therapy also significantly improves quality of life indicators, such as freedom from angina and chest pain.

“The FAME II cost-effectiveness analysis offers evidence that FFR-guided treatment is an economically attractive option that provides improved patient outcomes,” said Dr. William F. Fearon, associate professor, Stanford University Medical Center, who presented the data. “The results are quite different from what was seen in the COURAGE trial, and I believe further demonstrate that FFR is a critical contributing factor to successful PCIs.”

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